title: An Open-Label, Multicenter, Extension Study of AG-348 in Adult Subjects With Pyruvate Kinase Deficiency Previously Enrolled in AG-348 Studies

lead_sponsor: Agios Pharmaceuticals, Inc.

ReferenceCitation: Rab MAE, Van Oirschot BA, Kosinski PA, Hixon J, Johnson K, Chubukov V, Dang L, Pasterkamp G, Van Straaten S, Van Solinge WW, Van Beers EJ, Kung C, Van Wijk R. AG-348 (Mitapivat), an allosteric activator of red blood cell pyruvate kinase, increases enzymatic activity, protein stability, and ATP levels over a broad range of PKLR genotypes. Haematologica. 2021 Jan 1;106(1):238-249. doi: 10.3324/haematol.2019.238865.

location_country:
Denmark
Brazil
Portugal
Spain
Ireland
Italy
Netherlands
United Kingdom
Canada
Thailand
Switzerland
Korea, Republic of
United States
France
Turkey
Japan
Germany
Czechia

location_facility: Hospital Central da Faculdade de Medicina - USP

location_facility: Htal Clínico Universitario Virgen de la Arrixaca.

location_facility: Manchester University NHS Foundation Trust

location_facility: The Royal Liverpool and Broadgreen University

location_facility: Institute of Hematology and Blood Transfusion

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Indiana Hemophilia & Thrombosis Center Inc.

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: University of Arkansas for Medical Sciences

location_facility: Università della Campania "Luigi Vanvitelli"

location_facility: Charite - UB - CVK - Medizinische Klinik

location_facility: CHU Hopitaux de Bordeaux - Hôpital Saint-André

location_facility: Kansai Medical University, Dep. of Pediatrics, Hirakata Hospital

location_facility: Hacettepe University Faculty of Medicine

location_facility: UCSF Benioff Children's Hospital, Oakland

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Wayne State University School of Medicine

summary: This is a multicenter, open-label, extension study to evaluate the long-term safety, tolerability, and efficacy of treatment with AG-348 in participants who were previously enrolled in Study AG348-C-006 or Study AG348-C-007.


ipd_sharing: No

status: Terminated

primary_purpose: Treatment

intervention_type: Procedure

title: A Phase Ib/II Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission

study_completion_date_type: Actual

lead_sponsor: Hoffmann-La Roche

type: EudraCT Number

source: euctr

design_allocation: Non-Randomized

study_start_date_type: Actual

study_type: Interventional

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

enrollment_type: Actual

location_country:
Spain
Italy
Australia
United States
France

location_facility: Sarah Cannon Research Institute at HealthONE

location_facility: Hospital Universitario Virgen del Rocío; Servicio de Neuropediatra

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST); Onco-Ematologia

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

location_facility: UCLA Jonsson Comprehensive Cancer Center

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: University of Iowa Hospitals and Clinics; Investigational Drug Services

location_facility: ASST Papa Giovanni XXIII; Dipartimento Interaziendale di Farmacia Clinica

location_facility: University of Kansas Clinical Research Center; Clinical Trials Office

location_facility: Hospital Universitari i Politècnic La Fe

summary: This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of idasanutlin when it is given in combination with cytarabine and daunorubicin in induction, in combination with cytarabine in consolidation, and as a single agent in maintenance for treating participants with acute myeloid leukemia (AML).

lead_sponsor_type: industriel

status_simplified: Unknown


type: Other Identifier

title: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)

acronym: SLE-BRAVE-X

summary: The reason for this long term study is to see how safe and effective the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964).

design_allocation: Randomized

ipd_sharing: Yes

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
United States
Belgium
Japan
Philippines
Romania
South Africa
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
India
Israel
Mexico
Brazil
Switzerland
Hungary
China
Germany
Taiwan
Greece
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Clinica para el Diagnostico y Tratamiento de la Enfermedades

location_facility: Morales Vargas Centro de Investigacion, S.C.

location_facility: Centre hospitalier universitaire Pellegrin

location_facility: The First Affliated Hospital of Suzhou University

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

location_facility: The Feinstein Institute for Medical Research

location_facility: Clinical Research of West Florida, Inc. (Clearwater)

location_facility: Immanuel Krankenhaus Rheuma Klinik Berlin Buch

location_facility: Azienda Ospedaliera Santa Maria Della Misericordia

location_facility: Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum

location_facility: Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences

location_facility: Tianjin Medical University General Hospital

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: University of Occupational and Enviromental Health

location_facility: Synexus Affiliate - Sujata Birla Hospital & Medical Research Center

location_facility: City Clinical Hospital 1 named after N.I. Pirogov

location_facility: Kasturba Medical College Hospital, Mangalore

location_facility: First affiliated Hospital of Sun Yat-Sen University

location_facility: Napoca Emergency Clinical County Hospital

location_facility: Gen. Hosp. of Thessaloniki "Hippokration"

location_facility: HPTU-El Hospital con alma Pablo Tobon Uribe

location_facility: Klinika Reumatologii, Chorob Wewnetrznych i Geriatrii PUM

location_facility: Cincinnati Rheumatic Disease Study Group

location_facility: Centro de Estudos em Terapias Inovadoras-CETI

location_facility: Institute for Treatment and Rehabilitation Niska Banja

location_facility: Arizona Arthritis & Rheumatology Associates, P. C.

location_facility: Centro Peninsular de Investigacion S.C.P

location_facility: Twoja Przychodnia Centrum Medyczne Nowa Sol

location_facility: Orenburg State Medical Academy of Roszdrav

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: China Medical University (CMU) - First Affiliated Hospital

location_facility: Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy, Klinika Reumatologii i Chorob Tkanki Lacznej

location_facility: Arizona Arthritis & Rheumatology Research

location_facility: Centro de Investigación y Tratamiento Reumatológico S.C

location_facility: Vrije Universiteit Medisch Centrum Amsterdam

location_facility: Arthritis & Rheumatology Center of Oklahoma PLLC

location_facility: Research Institute of Clinical Immunology

location_facility: Russian National Research Medical University n.a. N.I.Pirogov

location_facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

location_facility: Shanghai Huashan Hospital Affil to Fu Dan University

location_facility: Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Angeles University Foundation and Medical Center

location_facility: V.A. Nasonova Research Institute of Rheumatology

location_facility: Russian Medical Military Academy n.a. S.M. Kirov

location_facility: People's Hospital of Xinjiang Uygur Autonomous Region

location_facility: Instituto de Investigaciones Clinicas Quilmes

location_facility: Sushruta Multispecialty Hospital & Research Center Pvt Ltd

location_facility: Aprillus Asistencia e Investigacion de Arcis Salud SRL

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.

location_facility: CINVEC- Estudos Clínicos Quinta Región Limitada

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

location_facility: Craiova Emergency Clinical County Hospital

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

location_facility: SER - Serviços Especializados em Reumatologia da Bahia S/S - ME

location_facility: The First Affiliated Hospital of Zhengzhou Universtiy

location_facility: Precision Comprehensive Clinical Research Solutions

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S. C.

location_facility: IR Medical Center S.A. Instituto de Reumatologia

location_facility: Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Seoul National University Bundang Hospital

location_facility: Box Arthritis & Rheumatology of the Carolinas, PLLC

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Sociedad Medica Del Aparato Locomotor SA

location_facility: Beijing Peking Union Medical College Hospital

location_facility: Békés Megyei Központi Kórház Pándy Kálmán Tagkórház

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika

location_facility: Universitätsmedizin Johannes Gutenberg Universität Mainz

location_facility: First Affiliated Hospital of the Harbin Medical University

location_facility: Klinikum der Universität München Großhadern

location_facility: Inland Rheumatology & Osteoporosis Medical Group

location_facility: Centro Integral en Reumatologia SA de CV

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Departmental Hospital at Smolensk Station "rzhd" JSC

location_facility: ChanRe Rheumatology And Immunology Center And Research

location_facility: Suite 509 Umhlanga Netcare Medical Centre

location_facility: The Rheumatology Research Unit Sunshine Coast

location_facility: Arthritis and Osteoporosis Associates of New Mexico

location_facility: Articularis Healthcare d/b/a/ Low Country Rheumatology, PA

location_facility: Centro de Alta Especialidad Reumatologia Inv del Potosi SC

location_facility: University General Hospital of Heraklion

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

location_facility: Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC)

location_facility: Integral Rheumatology & Immunology Specialists

location_facility: Regional General University Hospital of Larissa

location_facility: Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk

location_facility: Oncovida- Centro de Onco-Hematologia de Mato Grosso

intervention_type: Drug


title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients With Moderate Alzheimer's Disease

summary: This Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the clinical efficacy, safety, pharmacokinetics, and pharmacodynamics of semorinemab in patients with moderate AD. The study consists of a screening period, a double-blind treatment period, an optional open-label extension (OLE) period, and a safety follow-up period. There may be up to two study cohorts.

status: Active, not recruiting

study_completion_date_type: Anticipated

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)

lead_sponsor: Genentech, Inc.

location_country:
Poland
United States
Spain
France

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

location_facility: New Orleans Center for Clinical Research

location_facility: Neuropsychiatric Research; Center of Southwest Florida

location_facility: Empire Neurology PC; MS Center of Northeastern NY

location_facility: Stanford University; Stanford Clinical Cancer Ctr

location_facility: NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek

location_facility: Alzheimer's Research and Treatment Center

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Advanced Memory Research Institute of NJ

location_facility: Synexus Clinical Research US, Inc. - Orlando

location_facility: Rush University Medical Center - Chicago

location_facility: Butler Hospital; Movement Disorders Program

location_facility: KI Health Partners, LLC; New England Institute for Clinical Research

location_facility: Southern Illinois University, School of Medicine

location_facility: Collaborative Neuroscience Network, Inc.

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Brigham and Womens Hospital; Center for Alzheimer Research & Treatment

status_simplified: Ongoing


type: Registry Identifier

title: A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone Deficiency

summary: The study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Researchers will test to see how well somapacitan works. The study will also test if somapacitan is safe. Participants will either get somapacitan or Norditropin® - which treatment participants get, is decided by chance. Both participants and the study doctor will know which treatment participants get. The study will last for 4 years. Participants will attend 19 clinic visits and have 1 phone call with the study doctor.

ReferenceType: derived

ReferenceCitation: Miller BS, Blair JC, Rasmussen MH, Maniatis A, Kildemoes RJ, Mori J, Polak M, Bang RB, Böttcher V, Stagi S, Horikawa R. Weekly Somapacitan is Effective and Well Tolerated in Children with GH Deficiency: The Randomized Phase 3 REAL4 Trial. J Clin Endocrinol Metab. 2022 Sep 5. pii: dgac513. doi: 10.1210/clinem/dgac513. [Epub ahead of print]

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Japan
Poland
Slovenia
Austria
Russian Federation
India
Israel
Norway
Canada
Switzerland
Germany
Ireland
Latvia
Estonia
Thailand
Algeria
France
Korea, Republic of


title: An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion

acronym: RAVEN

summary: The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to central retinal vein occlusion (CRVO).

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Greece
Italy
Australia
Netherlands
Canada
Russian Federation
Thailand
United Kingdom
Hungary
Puerto Rico
United States
France
China
Israel
Malaysia
Japan
Germany
Turkey
Czechia

intervention_type: Other


title: A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)

acronym: AEGEAN

summary: This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
United States
Costa Rica
Peru
Belgium
Philippines
Japan
Romania
Poland
Austria
Russian Federation
Argentina
India
Mexico
Brazil
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Thailand
Vietnam
Korea, Republic of
France
Chile
Netherlands


acronym: Pembrolizumab (MK-3475) as First-Line Therapy for Advanced Merkel Cell Carcinoma

title: A Phase 3 Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) as First Line Therapy in Participants With Advanced Merkel Cell Carcinoma (KEYNOTE-913)

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Spain
Italy
Australia
New Zealand
Canada
United States
France
Sweden

location_facility: CHRU Lille - Hopital Claude Huriez ( Site 0200)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 0282)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0006)

location_facility: Hospital Clinic de Barcelona ( Site 0261)

location_facility: C.H.R.U. de Tours. Hopital Trousseau ( Site 0202)

location_facility: Hospital Universitario La Paz ( Site 0263)

location_facility: Azienda Ospedaliera Universitaria Senese ( Site 0224)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0055)

location_facility: Princess Margaret Cancer Centre ( Site 0051)

location_facility: Hopital de la Cote de Nacre - Caen ( Site 0204)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0004)

location_facility: Hospital General Universitario de Valencia ( Site 0262)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 0281)

location_facility: Melanoma Institute Australia ( Site 0400)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 0222)

location_facility: Hospital Universitari Vall d Hebron ( Site 0264)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 0203)

location_facility: Hopital Ambroise Pare Boulogne ( Site 0201)

location_facility: IEO Istituto Europeo di Oncologia ( Site 0223)

summary: This is a single-arm, open-label, multicenter, efficacy, and safety study of pembrolizumab in adult and pediatric participants with previously untreated advanced Merkel Cell Carcinoma (MCC). The primary objective of the trial is to assess the objective response rate, as assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, following administration of pembrolizumab.


status: Completed

acronym: JUVE-BASIS

title: A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JIA)

location_country:
Denmark
Poland
Brazil
Spain
Italy
Austria
Australia
Mexico
Argentina
Russian Federation
United Kingdom
France
India
China
Israel
Belgium
Japan
Germany
Turkey
Czechia

location_facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

location_facility: Sri Ramachandra MedicaL College & Research Institute

location_facility: Hospital Univ. "Dr. José Eleuterio González"

location_facility: ASST Spedali Civili - Università degli Studi

location_facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant

location_facility: Children's Hospital of Chongqing Medical University

location_facility: First Moscow State Medical University n.a. Sechenov

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Investigacion y Biomedicina de Chihuahua

location_facility: Centrum detske revmatologie VFN, Klinika detskeho a dorostoveho lekarstvi 1.LFUK a VFN v Praze

location_facility: Beijing Children's hospital, Capital Medical University

location_facility: Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie

location_facility: Great Ormond Street Hospital For Children NHS Foundation Trust

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Saint-Petersburg State Pediatric Medical University

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Tokyo Medical And Dental University Medical Hospital

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Niigata University Medical & Dental Hospital

location_facility: Center for Børnereumatologi. Børn og Unge, Århus Universitetshospital

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini

location_facility: Complexo Hospitalario Universitario A Coruña, CHUAC

location_facility: Tokyo Women's Medical University Hospital

location_facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C

location_facility: V.A. Nasonova Research Institute of Rheumatology

location_facility: Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau

location_facility: Capitol Institute of Pediatrics Children'S Hospital

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

location_facility: Universidade Federal de São Paulo - Escola Paulista de Medicina

location_facility: Hospital General de Niños Dr. Pedro de Elizalde

location_facility: Morozovsky Children's City Clinical Hospital

location_facility: CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej,Klinika Kardiologii i Reumatologii Dzieciecej

location_facility: Children's Hospital of Soochow University

location_facility: Charité Universitätsmedizin Berlin Campus Buch

summary: The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with JIA from 2 years to less than 18 years old.

status_simplified: Completed


status: Recruiting

acronym: JUVE-X

title: A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients From 1 Year to <18 Years of Age With Juvenile Idiopathic Arthritis (JIA)

enrollment_type: Anticipated

location_facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

location_facility: Sri Ramachandra MedicaL College & Research Institute

location_facility: Hospital Univ. "Dr. José Eleuterio González"

location_facility: Istanbul University Cerrahpasa Medical Faculty-Department of pediatric Rheumatology

location_facility: ASST Spedali Civili - Università degli Studi

location_facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant

location_facility: The Second Affiliated Hospital Chongqing Medical University

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Investigacion y Biomedicina de Chihuahua

location_facility: Centrum detske revmatologie VFN, Klinika detskeho a dorostoveho lekarstvi 1.LFUK a VFN v Praze

location_facility: Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli

location_facility: Detska revmatologie, Detska klinika, Fakultni nemocnice Olomouc

location_facility: Beijing Children's hospital, Capital Medical University

location_facility: Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie

location_facility: Great Ormond Street Hospital For Children NHS Foundation Trust

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Saint-Petersburg State Pediatric Medical University

location_facility: Children's Hospital Capital Institute of Pediatrics

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Oxford University Hospitals - Nuffield Orthopaedic Centre

location_facility: Niigata University Medical & Dental Hospital

location_facility: Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

location_facility: Instituto de Investigaciones Clínicas para la Salud

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Beijing Peking Union Medical College Hospital

location_facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences

location_facility: Instituto da Crianca do Hospital das Clinicas da FMUSP

location_facility: The Children's Hospital of Chongqing Medical University

summary: The reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of JIA in participants ages 1 to 17. This study is for participants that have been enrolled in studies I4V-MC-JAHV (NCT03773978) or I4V-MC-JAHU.


title: IDH Mutated 1p/19q Intact Lower Grade Glioma Following Resection: Wait Or Treat? IWOT - a Phase III Study

acronym: IWOT

summary: The 1635-EORTC-BTG study - Wait or Treat - concerns patients that represent a clinically favorable group of patients with IDHmutated astrocytoma (oligo-symptomatic), without a need for immediate post-operative treatment. It will establish whether early adjuvant treatment with radiotherapy and adjuvant temozolomide in resected IDHmutated astrocytoma will improve outcome, and whether benefits of early treatment outweigh potential side-effects of that, such as deterioration in neurocognitive function or Quality of Live, seizure activity and Patient Reported outcome compared to active surveillance.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Denmark
Spain
Italy
Austria
Australia
United Kingdom
Switzerland
France
Belgium
Netherlands

location_facility: IRCCS - Istituto Neurologico Carlo Besta

location_facility: Maastro Clinic - Maastricht Radiation Oncology

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Haaglanden Medisch Centrum (HMC) - Haaglanden MC - locatie Antoniushove

location_facility: Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Westmead Hospital - Crown Princess Mary Cancer Centre

location_facility: Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

location_facility: Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone (APHM)

location_facility: CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer

location_facility: Institut Catala d'Oncologia - Hospital Germans Trias i Pujol

location_facility: Oncology Institute of Southern Switzerland (IOSI)

location_facility: ETZ Tilburg - St. Elisabethziekenhuis TweeSteden

location_facility: Universitaetskliniken der Uni Wien - Universitaetsklinikum Wien - AKH uniklinieken

location_facility: Aarhus University Hospitals - Aarhus University Hospital-Skejby

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: Princess Alexandra Hospital - University of Queensland

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze

location_facility: Illawarra Cancer Care Centre - Wollongong Hospital

location_facility: Institut de Cancerologie Strasbourg Europe (formar Paul Strauss)

location_facility: Clatterbridge Centre for Oncology NHS Trust - Clatterbridge NHS -Wirral

location_facility: Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals

intervention_type: Radiation


acronym: ECZTRA 7

title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre, Phase 3 Trial Investigating the Efficacy, Safety, and Tolerability of Tralokinumab Administered in Combination With Topical Corticosteroids to Adult Subjects With Severe Atopic Dermatitis

lead_sponsor: LEO Pharma

location_country:
Poland
Spain
United Kingdom
France
Belgium
Germany
Czechia

summary:
Primary objective:

To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating severe AD in subjects who are not adequately controlled with or have contraindications to oral cyclosporine A (CSA).

Secondary objectives:

To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared to placebo in combination with TCS.

To evaluate the safety of tralokinumab in combination with TCS when treating severe AD in subjects who are not adequately controlled with or have contraindications to oral CSA compared to placebo in combination with TCS.


acronym: Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (TRuE AD1)

title: A Phase 3, Double-Blind, Randomized, 8-Week, Vehicle-Controlled Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Adolescents and Adults With Atopic Dermatitis

lead_sponsor: Incyte Corporation

ReferenceCitation: Bloudek L, Eichenfield LF, Silverberg JI, Joish VN, Lofland JH, Sun K, Augustin M, Migliaccio-Walle K, Sullivan SD. Impact of Ruxolitinib Cream on Work Productivity and Activity Impairment and Associated Indirect Costs in Patients with Atopic Dermatitis: Pooled Results From Two Phase III Studies. Am J Clin Dermatol. 2022 Oct 20. doi: 10.1007/s40257-022-00734-8. [Epub ahead of print]

ReferenceCitation: Gong X, Chen X, Kuligowski ME, Liu X, Liu X, Cimino E, McGee R, Yeleswaram S. Pharmacokinetics of Ruxolitinib in Patients with Atopic Dermatitis Treated With Ruxolitinib Cream: Data from Phase II and III Studies. Am J Clin Dermatol. 2021 Jul;22(4):555-566. doi: 10.1007/s40257-021-00610-x. Epub 2021 May 12.

ReferenceCitation: Papp K, Szepietowski JC, Kircik L, Toth D, Eichenfield LF, Leung DYM, Forman SB, Venturanza ME, Sun K, Kuligowski ME, Simpson EL. Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: Results from 2 phase 3, randomized, double-blind studies. J Am Acad Dermatol. 2021 Oct;85(4):863-872. doi: 10.1016/j.jaad.2021.04.085. Epub 2021 May 4.

ReferenceCitation: Scuron MD, Fay BL, Connell AJ, Peel MT, Smith PA. Ruxolitinib Cream Has Dual Efficacy on Pruritus and Inflammation in Experimental Dermatitis. Front Immunol. 2021 Feb 15;11:620098. doi: 10.3389/fimmu.2020.620098. eCollection 2020.

location_country:
Poland
Italy
Canada
Hungary
United States
France
Germany

location_facility: Medycyna Kliniczna Marzena Waszczak-Jeka

location_facility: Dawes Fretzin Clinical Research Group LLC

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o

location_facility: Synexus Affiliate - Synexus Magyarorszag Kft. Debrecen

location_facility: Alliance for Multispecialty Research, LLC

location_facility: Synexus (DRS) - Synexus Magyarország Kft. Gyula

location_facility: Well Pharma Medical Research Corporation

location_facility: Clinical Research Institute Of Southern Oregon - Crisor

location_facility: Synexus (DRS) - Synexus Magyarország Kft. Budapest

location_facility: Synexus (DRS) - Synexus Magyarország Kft. Zalaegerszeg

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Synexus Polska Sp. z o.o. Oddzial w Poznaniu

summary: The purpose of this study is to assess the efficacy and safety of twice daily ruxolitinib cream in adolescents and adults with Atopic Dermatitis (AD).


title: A Phase 3 Double-blind Randomized Study to Assess the Efficacy and Safety of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late Onset Pompe Disease Compared With Alglucosidase Alfa/Placebo

summary: This is a phase 3 double-blind randomized study to study the efficacy and safety of intravenous ATB200 Co-administered with oral AT2221 in adult subjects with Late Onset Pompe Disease compared with Alglucosidase Alfa/placebo.

ReferenceCitation: Schoser B, Roberts M, Byrne BJ, Sitaraman S, Jiang H, Laforêt P, Toscano A, Castelli J, Díaz-Manera J, Goldman M, van der Ploeg AT, Bratkovic D, Kuchipudi S, Mozaffar T, Kishnani PS; PROPEL Study Group. Safety and efficacy of cipaglucosidase alfa plus miglustat versus alglucosidase alfa plus placebo in late-onset Pompe disease (PROPEL): an international, randomised, double-blind, parallel-group, phase 3 trial. Lancet Neurol. 2021 Dec;20(12):1027-1037. doi: 10.1016/S1474-4422(21)00331-8.

lead_sponsor: Amicus Therapeutics

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Poland
Slovenia
Austria
Australia
Argentina
Sweden
Bosnia and Herzegovina
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
New Zealand
Korea, Republic of
France
Netherlands

location_facility: Washington University School of Medicine

location_facility: Semmelweis University, Institute of Genomic Medicine and Rare Disease

location_facility: Rigshospitalet Copenhagen Neuromuscular Center

location_facility: The Feinstein Institute for Medical Research

location_facility: University of Minnesota Clinical Research Unit

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: National Center of Neurology and Psychiatry

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University of Utah, Center for Clinical and Translational Sciences

location_facility: University of Arkansas for Medical Sciences

location_facility: UOC di Neurologia e Malattie Neuromuscolari

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: University of Texas Health Science Center San Antonio

location_facility: The Ohio State University Wexner Medical Center

location_facility: Heritage Medical Research Clinic, University of Calgary

location_facility: University of South Florida Research Center

location_facility: UF Helath: University of Florida Clinical Research Center

location_facility: Indiana University Health Neuroscience Center

intervention_type: Biological


title: Personalized CRT - Product Surveillance Registry (PSR)

summary: The purpose of this study is to evaluate the cardiac resynchronization therapy (CRT) response in a real-world patient population and evaluate options to address non-response and patient management.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic

location_country:
Serbia
Spain
Italy
United Kingdom
Netherlands
Canada
Sweden
Korea, Republic of
United States
France
Malaysia
Belgium
Germany

intervention_type: Device


title: SOLAR: A Phase 2, Randomized, Open-label, Parallel-group, Active Comparator, Multi-center Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype

acronym: SOLAR

summary:
The main objective of this clinical trial is to study the efficacy and safety of cobomarsen (also known as MRG-106) for the treatment of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) subtype. Cobomarsen is designed to inhibit the activity of a molecule called miR-155 that may be important to the growth and survival of MF cancer cells. The study will compare the effects of cobomarsen to vorinostat, a drug that has been approved for the treatment of CTCL in the United States and several other countries.

Participants in the clinical trial will be randomly assigned to receive either weekly doses of cobomarsen by injection into a vein or daily oral doses of vorinostat. Participants will continue on their assigned treatment as long as there is no evidence of progression of their cancer. The effects of treatment will be measured based on changes in skin lesion severity, as well as the length of time that the subject's disease remains stable or improved, without evidence of disease progression. The safety and tolerability of cobomarsen will be assessed based on the frequency and severity of observed side effects.

Participants assigned to receive vorinostat who experience progression of their disease during their participation in this study may have the option to be treated with cobomarsen in an open-label, crossover arm of the same study if they meet the entry criteria for that part of the study.

ReferenceCitation: Ganguly K, Kishore U, Madan T. Interplay between C-type lectin receptors and microRNAs in cellular homeostasis and immune response. FEBS J. 2021 Jul;288(14):4210-4229. doi: 10.1111/febs.15603. Epub 2020 Nov 7. Review.

ReferenceCitation: Valipour A, Jäger M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7:CD008946. doi: 10.1002/14651858.CD008946.pub3.

lead_sponsor: miRagen Therapeutics, Inc.

location_country:
Spain
Italy
United Kingdom
Australia
Canada
United States
France
Belgium

location_facility: Washington University School of Medicine

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Guy's and St. Thomas' NHS Foundation Trust, Cancer Center

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: University Hospitals of Birmingham NHS Foundation Trust, Queen Elizabeth Hospital

location_facility: Consorcio Hospital General Universitario Valencia

location_facility: Chao Family Comprehensive Cancer Center at University of California, Irvine

location_facility: AOU Citta dell Salute e della Scienza di Torino


title: A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-203)

summary: The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced solid tumors where the efficacy of PD-1 inhibitors has previously been established.

location_country:
Poland
Spain
Italy
Austria
Hungary
United States
France
Romania

location_facility: Christiana Care Helen F. Graham Cancer Center

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc.

location_facility: Azienda Ospedaliera Universitaria Ospedali Riuniti di Ancona

location_facility: Centrum Onkologii- Instytut im Marii Skłodowskiej Curie

location_facility: Oncology & Hematology Associates of Southwest Virginia, Inc.

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: St. Joseph Health Medical Group - Annadel Medical Group

location_facility: Texas Oncology Surgical Specialists - Austin Central

location_facility: Clinical Emergency Hospital of Constanta

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Rocky Mountain Cancer Centers - Denver - Midtown

location_facility: California Cancer Associates for Research and Excellence, Inc.


title: A Phase Ib/II, Open-Label, Multicenter, Randomized, Controlled Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Poland
Spain
Austria
Korea, Republic of
United States
France

location_facility: University of Miami Miller School of Medicine

location_facility: Instytut Hematologii i Transfuzjologii; Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: University of California; Moores Cancer Center

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

location_facility: Institut Catala d´Oncologia Hospital Germans Trias i Pujol

location_facility: CHU Henri Mondor; Service d'Oncologie Medicale

location_facility: Katedra i Klinika Hematologii; Nowotworów Krwi i Transplantacji Szpiku

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Centre Henri Becquerel- Centre de Lutte Contre le Cancer

location_facility: Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien

location_facility: Pusan National University Yangsan Hospital

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU

location_facility: University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica

location_facility: Hospital San Pedro de Alcantara; Servicio de Hematología

summary: This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin (CHP-pola) in participants with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), and in previously untreated participants with diffuse large B-cell lymphoma (DLBCL).


title: A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations

summary: To evaluate the safety and efficacy of IPX203 (carbidopa and levodopa) extended-release capsules (IPX203 ER CD-LD) in comparison to immediate release (IR) CD-LD in the treatment of CD-LD-experienced subjects with Parkinson's disease (PD) who have motor fluctuations.

lead_sponsor: Impax Laboratories, LLC

location_country:
Poland
Spain
Italy
United Kingdom
United States
France
Germany
Czechia

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health (142)

location_facility: Neurologicka ordinace FORBELI s.r.o.(706)

location_facility: University of Florida Health Science Center(129)

location_facility: Roseman Medical Research Institute/Roseman Medical Group (154)

location_facility: St. Josef-Hospital, Universitatsklinik fur Neurologie, Klinisches Forschungszentrum fur Neurodegeneration (301)

location_facility: INSERM, Centre d'investigation Clinique 1402, CHU de Poitiers (402)

location_facility: Keck School of Medicine of USC/University of Southern California (106)

location_facility: Hospital Universitario Infanta Sofia (513)

location_facility: Wake Forest Baptist Health Sciences (127)

location_facility: Fondazione lstituto Neurologico Nazionale "C. Mondino" (606)

location_facility: Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice, Neurologicka klinika (702)

location_facility: Hospital Universitario Vall d' Hebron (505)

location_facility: Booth Gardner Parkinson's Care Center (112)

location_facility: Hospital Universitario Quiron Dexeus (501)

location_facility: Christiana Care Neurology Specialists (153)

location_facility: University of Arkansas for Medical Sciences (117)

location_facility: Dr. med. REINHARDT Ehret Neurologie Berlin Schlobstr. 29 (309)

location_facility: University Hospitals Cleveland Medical Center (123)

location_facility: Hospital Genral Universitario de Elche (509)

location_facility: University of Miami-UHealth at Boca Raton (152)

location_facility: NZOZ Neuromed M. i M Nastaj Spolka Partnerska(800)

location_facility: Klinik Haag i. OB, Geriatric Hospital (305)

location_facility: Premiere Research Institute at Palm Beach Neurology (174)

location_facility: Kliniken Beelitz GmbH, Neurologisches Fachkrankenhaus fUr Bewegungsstorungen/Parkinson (300)

location_facility: Rocky Mountain Movement Disorders Center (116)

location_facility: CHU de Montpellier, Hopital Gui de Chauliac(405)

location_facility: CHU de Clermont-Ferrand - Hopital Gabriel Montpied (404)

location_facility: Klinikum rechts der lsar der TUM, Klinik und Poliklinik fur Neurologie (303)

location_facility: St. Joseph's Hospital & Medical Center/ Barrow Neurological Institute (156)

location_facility: Neurology Consultants of Dallas, PA (108)

location_facility: Houston Methodist Neurological Institute/Movement Disorders Clinic (135)

location_facility: Azienda Ospedaliero-Universitaria Pisana (602)

location_facility: Hospital Universitario Ramon y Cajal (500)

location_facility: University of Toledo, Gardner-McMaster Parkinson Center (122)

location_facility: Centre Hospitalier Universitaire de Nice (400)

location_facility: University of Texas Southwestern Medical Center (143)

location_facility: Department "G.F. Ingrassia" Section of neuroscience-Policlinico "Vittorio Emanuele" (608)

location_facility: VCU Health - Neuroscience, Orthopaedic and Wellness Center (124)

location_facility: Fakultni nemocnice u sv. Anny v Brne, I. neurologicka klinika (704)

location_facility: Northwestern Medical Group Neurology Clinic(145)

location_facility: Imperial College Healthcare NHS Trust (200)

location_facility: Parkinsons's Disease Treatment Center of Southwest Florida (131)

location_facility: Hospital Universitario y politecnico La Fe (515)

location_facility: Medical Professional Clinical Research Center, INC (163)

location_facility: Gemeinschaftspraxis Dr. med. Joachim Springub/ Wolfgang Schwarz, Studienzentrum Nord-West (306)

location_facility: Medical University of South Carolina (150)

location_facility: Krakowska Akademia Neurologii Sp. z o.o.(802)

location_facility: NZOZ Neuro-Kard Ilkowski i Partnerzy Spolka Partnerska Lekarzy (801)

location_facility: Department of Neuroscience, Mental Health and Sensory System (NeSMOS), Sapienza University (603)

location_facility: Hospital Universitari General de Catalunya (504)

location_facility: Loma Linda University Health Care, Department of Neurology (137)

location_facility: Hospital Universitario Virgen del Rocio (503)

location_facility: Hospital Universitario de la Princesa (508)

location_facility: Movement Disorder Clinic of Oklahoma (115)

location_facility: Hospitalaries Del Sagrat Cor De Jesus Hospital Sant Rafael (516)

location_facility: Curiositas ad sanum, Studien und Beratungs GmbH(311)

location_facility: Hospital Universitari Mutua Terrassa (506)

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton (121)

location_facility: Centre d'Investigation Clinique 1436-CHU Purpan-Hopital Pierre Paul Riquet (403)

location_facility: Centro Ricerca Parkinson San Raffaele Cassino (601)

location_facility: Henry Ford West Bloomfield Hospital (100)

location_facility: University of Colorado Hospital Anschutz Outpatient Pavilion (120)

location_facility: Mount Sinai West-Department of Neurology(172)

location_facility: Hoag Memorial Hospital Presbyterian (134)

location_facility: Hospital De La Santa Creu i Sant Pau (502)

location_facility: Indiana University Health Neuroscience Center (164)

location_facility: University of Kansas Medical Center (118)

location_facility: Universitatsklinikum Carl Gustav Carus, Klinik und Poliklinik fur Neurologie (307)

location_facility: University of Rome Tor Vergata/Hospital Tor Vergata (605)


title: Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks

summary: The reason for this study is to see how effective and safe the study drug known as lasmiditan is in the acute treatment of 4 migraine attacks with or without aura.

ReferenceCitation: Zhou J, Luo G, Xu Y, Yang X, Pan X, Dong Z, Zhong S, Liu H, Ji F, Yu S. Safety Findings in Lasmiditan as a Novel Acute Treatment of Migraine in Chinese Patients: A Post Hoc Analysis of the Randomized Controlled Phase 3 CENTURION Trial. Adv Ther. 2022 Nov;39(11):5229-5243. doi: 10.1007/s12325-022-02291-2. Epub 2022 Sep 17.

ReferenceCitation: MacGregor EA, Komori M, Krege JH, Baygani S, Vincent M, Pavlovic J, Igarashi H. Efficacy of lasmiditan for the acute treatment of perimenstrual migraine. Cephalalgia. 2022 Aug 18:3331024221118929. doi: 10.1177/03331024221118929. [Epub ahead of print]

ReferenceCitation: Doty EG, Hauck PM, Krege JH, Komori M, Hake AM, Dong Y, Lipton RB. The Association Between the Occurrence of Common Treatment-Emergent Adverse Events and Efficacy Outcomes After Lasmiditan Treatment of a Single Migraine Attack: Secondary Analyses from Four Pooled Randomized Clinical Trials. CNS Drugs. 2022 Jul;36(7):771-783. doi: 10.1007/s40263-022-00928-y. Epub 2022 Jul 2.

ReferenceCitation: Yu T, He L, Yang X, Zhou J, Luo G, Wang H, Zhao H, Hu Q, Ji F, Yu S. Efficacy and Safety of Lasmiditan as a Novel Acute Treatment in Chinese Patients with Migraine: A Subpopulation Analysis of the Randomized Controlled Phase 3 CENTURION Trial. Neurol Ther. 2022 Sep;11(3):1269-1283. doi: 10.1007/s40120-022-00369-1. Epub 2022 Jun 17.

ReferenceCitation: Krege JH, Lipton RB, Baygani SK, Komori M, Ryan SM, Vincent M. Lasmiditan for Patients with Migraine and Contraindications to Triptans: A Post Hoc Analysis. Pain Ther. 2022 Jun;11(2):701-712. doi: 10.1007/s40122-022-00388-8. Epub 2022 Apr 26.

ReferenceCitation: Tassorelli C, Bragg S, Krege JH, Doty EG, Ardayfio PA, Ruff D, Dowsett SA, Schwedt T. Safety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine. J Headache Pain. 2021 Nov 6;22(1):132. doi: 10.1186/s10194-021-01343-2.

ReferenceCitation: Reuter U, Krege JH, Lombard L, Gomez Valderas E, Krikke-Workel J, Dell-Agnello G, Dowsett SA, Buse DC. Lasmiditan efficacy in the acute treatment of migraine was independent of prior response to triptans: Findings from the CENTURION study. Cephalalgia. 2022 Jan;42(1):20-30. doi: 10.1177/03331024211048507. Epub 2021 Oct 13.

ReferenceCitation: Ashina M, Reuter U, Smith T, Krikke-Workel J, Klise SR, Bragg S, Doty EG, Dowsett SA, Lin Q, Krege JH. Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study. Cephalalgia. 2021 Mar;41(3):294-304. doi: 10.1177/0333102421989232. Epub 2021 Feb 4.

location_country:
Denmark
Spain
Italy
Austria
Mexico
Netherlands
Russian Federation
United Kingdom
Switzerland
Hungary
United States
France
China
India
Belgium
Germany
Czechia

location_facility: Synexus Thames Valley Clinical Research Centre

location_facility: Rehabilitation & Neurological Services LLC

location_facility: Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.

location_facility: HuaShan Hospital Affiliated To Fudan University

location_facility: No.2 Hospital Affiliated to Jilin University

location_facility: Synexus Merseyside Clinical Research Centre

location_facility: The First Affliated Hospital of Suzhou University

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH

location_facility: Tianjin Medical University General Hospital

location_facility: First Moscow State Medical University n.a. Sechenov

location_facility: Beijing Tiantan Hospital Affiliated to Capital Medical Univ

location_facility: The First Affiliated Hospital of Harbin Medical University

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Synexus Lancashire Clinical Research Centre

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: No 1 Affiliate Hospital of Kunming Medical College

location_facility: Synexus Midlands Clinical Research Center

location_facility: George Washington University Medical Center

location_facility: CRI Centro Regiomontano de Investigacion S.C.

location_facility: Fondazione Istituto Neurologico Nationale C. Mondino

location_facility: Synexus Scotland Clinical Research Centre

location_facility: Mangala Hospitals & Mangala Kidney Foundation

location_facility: Centro de Atención e Investigación Cardiovascular del Potosí S.C.

location_facility: Deenanth Mangeshkar Hospital and Research Centre

location_facility: Center for Clinical and Basic Research -CCBR

location_facility: Neurologicka ambulance, Neurologie Brno s.r.o.

location_facility: Synexus Manchester Clinical Research Centre

location_facility: UCSD Altman Clinical & Translational Research Institute (ACTRI)

location_facility: Centre Hospitalier Annecy Genevois - Site d'Annecy

location_facility: First Affiliated Hospital of Gannan Medical University

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C

location_facility: First Affiliated Hospital of Xi'an Jiaotong University

location_facility: First hospital affiliated to Zhengzhou University

location_facility: Dalian Municipal Central Hospital Affiliated of Dalian Medical University

location_facility: The First Affiliated Hospital of Wenzhou Medical College

location_facility: Valdor - ISOSL CCV - Clinique des céphalées du Valdor - Neurology

location_facility: The First Affiliated Hospital Chongqing Medical University

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: West China Hospital of Sichuan University

location_facility: Xiangya Hospital, Central South University

location_facility: Xuanwu Hospital-Capital Medical University

location_facility: Gemeinschaftspraxis für Neurologie und Psychiatrie

location_facility: The University of Hong Kong-Shenzhen Hospital

location_facility: Affiliated Hospital of Jiangsu University

location_facility: Hospital Universitario Marques De Valdecilla

location_facility: Saint Petersburg State Medical University n.a. Pavlov I.P.

location_facility: KH der Barmherzigen Schwestern Linz BetriebsGesmbH


acronym: CheckMate 848

title: A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination With Ipilimumab or Nivolumab Monotherapy in Participants With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

lead_sponsor: Bristol-Myers Squibb

location_country:
Denmark
Poland
Romania
Spain
Italy
United Kingdom
Australia
Netherlands
Argentina
Canada
Puerto Rico
United States
Chile
France
Singapore
Belgium
Germany

location_facility:
John Wayne Cancer Center
Local Institution - 0094
Duke Cancer Institute
Local Institution - 0068
Local Institution - 0106
Local Institution - 0107
Local Institution - 0078
Local Institution - 0036
Texas Oncology - Northeast Texas
Local Institution - 0119
Local Institution - 0113
Local Institution - 0069
Local Institution - 0062
Local Institution - 0090
Local Institution - 0029
Local Institution - 0010
Local Institution - 0112
Local Institution - 0015
Local Institution - 0071
Local Institution - 0093
Local Institution - 0088
Local Institution - 0080
Local Institution - 0018
Local Institution - 0076
Local Institution - 0110
Rocky Mountain Cancer Centers
Local Institution - 0075
Local Institution - 0030
Local Institution - 0016
Local Institution - 0082
Local Institution - 0114
Local Institution - 0087
Local Institution - 0085
Local Institution - 0073
Local Institution - 0115
Local Institution - 0060
Local Institution - 0001
Local Institution - 0084
Local Institution - 0031
Local Institution - 0065
Fundacion De Investigacion
Local Institution - 0081
Local Institution - 0074
Local Institution - 0039
Local Institution - 0086
Broome Oncology
Local Institution - 0083
Local Institution - 0118
Local Institution - 0066
Local Institution - 0002
Local Institution - 0043
Local Institution - 0079
Local Institution - 0095
Local Institution - 0077
Local Institution - 0117
Local Institution - 0072
Local Institution - 0070
Local Institution - 0032
Local Institution - 0116
Local Institution - 0067

summary: The purpose of this study is to demonstrate the clinical activity of nivolumab in combination with ipilimumab in multiple types of tumors based on their Tumor Mutational Burden status.


title: A Prospective Observational Multi-center 4 Cohort Study Comparing Robotic Assisted and Laparoscopic Invasive Right Colectomy and Intracorporeal Anastomosis Versus Extracorporeal Anastomosis

acronym: MIRCAST

summary:
Right colectomy (hemicolectomy) involves the removal of the cecum, the ascending colon, the hepatic flexure, the first one-third of the transverse colon, part of the terminal ileum, and the associated regional fat and lymph nodes, and is the accepted treatment for malignant neoplasms of the right colon.

A minimally invasive approach is commonly used for right colectomy, with studies reporting reduced complications, less blood loss, and hospital stay when compared to an open approach.

However, there remains controversy regarding whether robotic assistance is advantageous for this technique and whether an intracorporeal (ICA) or extracorporeal anastomosis (ECA) is best.

MIRCAST is a prospective, observational, international, multi-center, 4-parallel-cohorts study. Sites or surgeons will select a cohort of the study for which they are qualified. Four cohorts will be the subject of study:

Robotic Right Colectomy with ICA
Robotic Right Colectomy with ECA
Laparoscopic Right Colectomy with ICA
Laparoscopic Right Colectomy with ECA

All patient assessments will be done according to the sites standard of care. Parameters routinely recorded during right colectomy surgery will be collected prospectively. Enrolled subjects will undergo assessments at the following intervals: pre-operative, operative, discharge, 30 days, 3 months, 1 year and 2 years post-surgery.

status: Unknown status

ReferenceCitation: Gomez Ruiz M, Bianchi PP, Chaudhri S, Gerjy R, Gögenur I, Jayne D, Khan JS, Rautio T, Sánchez-Guillén L, Spinoglio G, Ulrich A, Rouanet P. Minimally invasive right colectomy anastomosis study (MIRCAST): protocol for an observational cohort study of surgical complications using four surgical techniques for anastomosis in patients with a right colon tumor. BMC Surg. 2020 Jul 13;20(1):151. doi: 10.1186/s12893-020-00803-x.

lead_sponsor: Instituto de Investigación Marqués de Valdecilla

location_country:
Denmark
Croatia
Portugal
Spain
Greece
Italy
United Kingdom
Finland
France
Germany

location_facility: ICM - Institut Régional du Cancer de Montpellier

location_facility: Hospital Universitario Marqués de Valdecilla


acronym: Trial of 1L Pembrolizumab Plus Chemotherapy in Persistent, Recurrent, or Metastatic Cervical Cancer

title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)

ReferenceCitation: Colombo N, Dubot C, Lorusso D, Caceres MV, Hasegawa K, Shapira-Frommer R, Tewari KS, Salman P, Hoyos Usta E, Yañez E, Gümüş M, Olivera Hurtado de Mendoza M, Samouëlian V, Castonguay V, Arkhipov A, Toker S, Li K, Keefe SM, Monk BJ; KEYNOTE-826 Investigators. Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer. N Engl J Med. 2021 Nov 11;385(20):1856-1867. doi: 10.1056/NEJMoa2112435. Epub 2021 Sep 18.

location_country:
Taiwan
Spain
Italy
Russian Federation
Australia
Mexico
Argentina
Canada
Ukraine
Korea, Republic of
United States
Chile
France
Israel
Colombia
Japan
Germany
Peru
Turkey

location_facility: Centro Estatal de Cancerologia de Chihuahua ( Site 1123)

location_facility: London Regional Cancer Program - London HSC ( Site 1723)

location_facility: Policlinico Universitario -Agostino Gemelli ( Site 1241)

location_facility: BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 1734)

location_facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 1153)

location_facility: Gynoncological Practice Lueck. Schrader. Noeding ( Site 1224)

location_facility: MI Odessa Regional Oncological Centre ( Site 1493)

location_facility: The Jikei University Hospital ( Site 1697)

location_facility: Centro Oncologico Riojano Integral ( Site 1004)

location_facility: Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 1152)

location_facility: FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1334)

location_facility: University of the Ryukyus Hospital ( Site 1706)

location_facility: Istituto Europeo di Oncologia ( Site 1250)

location_facility: University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 1784)

location_facility: Seattle Cancer Care Alliance ( Site 1777)

location_facility: West Cancer Center - East Campus ( Site 1763)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 1367)

location_facility: Arizona Oncology Associates, PC- HAL ( Site 8005)

location_facility: Hospital Nacional Arzobispo Loayza ( Site 1159)

location_facility: Instituto Medico Especializado Alexander Fleming ( Site 1009)

location_facility: Columbia University Medical Center ( Site 1800)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 1633)

location_facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 1729)

location_facility: The Jikei University Kashiwa Hospital ( Site 1701)

location_facility: City Clinical Hosp.4 of DCC ( Site 1482)

location_facility: National Cancer Center Hospital ( Site 1702)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 1636)

location_facility: Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 1125)

location_facility: Hacettepe University Medical Faculty ( Site 1459)

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 1214)

location_facility: National Hospital Organization Hokkaido Cancer Center ( Site 1700)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 1703)

location_facility: Rotkreuzklinikum Muenchen gGmbH. Studienzentrale Frauenklinik ( Site 1225)

location_facility: Centro de Cancer Nuestra Senora de la Esperanza ( Site 1063)

location_facility: Kaohsiung Veterans General Hospital ( Site 1632)

location_facility: Medeniyet University Goztepe Egitim ve Arastırma Hast. Merdivenkoy ( Site 1458)

location_facility: Sunnybrook Research Institute ( Site 1733)

location_facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1006)

location_facility: Sociedad de Oncologia y Hematologia del Cesar Ltda. ( Site 1103)

location_facility: Barbara Ann Karmanos Cancer Institute ( Site 1785)

location_facility: Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 1456)

location_facility: Texas Oncology-San Antonio Medical Center ( Site 8001)

location_facility: H. Lee Moffitt Cancer Center and Research Institute ( Site 1754)

location_facility: Princess Margaret Cancer Centre ( Site 1732)

location_facility: Baskent Universitesi Ankara Hastanesi ( Site 1451)

location_facility: Universitatsklinikum Essen AoR ( Site 1213)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 1489)

location_facility: Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1275)

location_facility: MUSC Hollings Cancer Center ( Site 1819)

location_facility: National Cancer Center Hospital East ( Site 1704)

location_facility: Taichung Veterans General Hospital ( Site 1634)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 1487)

location_facility: Centro Medico Monte Carmelo ( Site 1156)

location_facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1276)

location_facility: A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1245)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1331)

location_facility: Universitaetsklinikum Duesseldorf ( Site 1220)

location_facility: CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 1127)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1242)

location_facility: Consultorio de Medicina Especializada del Sector Privado ( Site 1129)

location_facility: Hospital Nacional Maria Auxiliadora ( Site 1155)

location_facility: Hospital de Oncologia Angel Roffo ( Site 1003)

location_facility: St John of God Subiaco Hospital ( Site 1512)

location_facility: Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1457)

location_facility: Queen Elizabeth II Health Sciences Centre ( Site 1731)

location_facility: National Research Ogarev Mordovia State University ( Site 1347)

location_facility: Washington University School of Medicine ( Site 1779)

location_facility: Smilow Cancer Hospital at Yale New Haven ( Site 1809)

location_facility: Saitama Medical University International Medical Center ( Site 1691)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 1061)

location_facility: Instituto Nacional de Cancerologia. ( Site 1130)

location_facility: The Cancer Institute Hospital of JFCR ( Site 1698)

location_facility: Cancer Institute of New Jersey at University Hospital ( Site 1762)

location_facility: Mater Misericordiae Ltd Mater Cancer Care Centre ( Site 1521)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1768)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 1095)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 1158)

location_facility: CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 1724)

location_facility: Medical Care and Research S.A. de C.V. ( Site 1135)

location_facility: Taipei Veterans General Hospital ( Site 1631)

location_facility: Groupe Hospitalier Broca Cochin Hotel Dieu ( Site 1183)

location_facility: BC Cancer - Vancouver Center ( Site 1722)

location_facility: Hospital Universitario Virgen Macarena ( Site 1274)

location_facility: National Medical Research Center of Oncology n.a. N. N. Petrov ( Site 1348)

location_facility: Keimyung University Dongsan Medical Center ( Site 1603)

location_facility: China Medical University Hospital ( Site 1635)

location_facility: Medical Rehabilitation Center ( Site 1337)

location_facility: Monash Health-Monash Medical Centre ( Site 1519)

location_facility: Iwate Medical University Hospital ( Site 1695)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 1452)

location_facility: Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 1157)

location_facility: Akdeniz Universitesi Tip Fakultesi ( Site 1453)

location_facility: Tomsk Scientific Research Institute of Oncology ( Site 1360)

location_facility: MD Anderson Cancer Center Madrid ( Site 1273)

location_facility: Instituto Clinico Oncologico del Sur ( Site 1062)

location_facility: Georgia Cancer Center at Augusta University ( Site 1767)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 1211)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 1726)

location_facility: Novosibirsk Regional Clinical Oncology Dispensary ( Site 1358)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1345)

location_facility: Medical Centre LLC Oncolife ( Site 1485)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1721)

location_facility: Institut Curie - Centre Rene Huguenin ( Site 1185)

location_facility: Universitatsklinikum Hamburg-Eppendorf ( Site 1212)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 1484)

location_facility: Shaare Zedek Medical Center ( Site 1366)

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 1730)

location_facility: Centro di Riferimento Oncologico de Aviano Istituto Nazionale Tumori ( Site 1243)

location_facility: Instituto Cancerologico de Narino Ltda ( Site 1097)

location_facility: The Ottawa Hospital Cancer Centre ( Site 1736)

location_facility: Seoul National University Hospital ( Site 1602)

location_facility: Municipal Clinical Oncology Center ( Site 1346)

summary:
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab.

The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS).


title: A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab as First Line Therapy for Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects (CANOPY-1)

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Spain
Italy
United Kingdom
United States
Iceland
Japan
Philippines
Romania
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
India
Turkey
Norway
Malaysia
Singapore
Sweden
Slovakia
Brazil
Lebanon
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Greece
Finland
Thailand
Vietnam
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: USC Kenneth Norris Comprehensive Cancer Center

summary:
This is a phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC subjects.

The study will assess primarily the safety and tolerability (safety run-in part) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab and then the efficacy (double-blind, randomized, placebo controlled part) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.


title: A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Canakinumab in Combination With Docetaxel Versus Placebo in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancer (NSCLC) Previously Treated With PD-(L)1 Inhibitors and Platinum-based Chemotherapy (CANOPY 2)

location_country:
Spain
Italy
United States
Belgium
Japan
Czechia
Poland
Russian Federation
Australia
Argentina
Israel
Singapore
Brazil
Lebanon
Canada
Hungary
China
Germany
Denmark
Taiwan
Jordan
Greece
Korea, Republic of
France
Chile
Netherlands

location_facility: Saint Luke's Hospital/Marion Bloch Neuroscience Institute Dept of Regulatory

location_facility: Montefiore Medical Center Albert Einstein College of Med

location_facility: Emory University School of Medicine/Winship Cancer Institute

location_facility: University of Cincinnati Cancer Institute

summary: This phase III study is designed to evaluate the role of IL-1β inhibition in combination with docetaxel in subjects with advanced NSCLC previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy. The randomized III part will be preceded by a safety run-in part in which the recommended dose of the combination of canakinumab and docetaxel will be confirmed.


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus

acronym: BRAVE II

summary: The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

location_country:
Poland
Romania
Serbia
Spain
Italy
Argentina
Philippines
Korea, Republic of
France
United States
Chile
India
Colombia
Japan
South Africa

location_facility: Centre hospitalier universitaire Pellegrin

location_facility: Clinical Research of West Florida, Inc. (Clearwater)

location_facility: Azienda Ospedaliera Santa Maria Della Misericordia

location_facility: NHL Municipal Medical College & VS General Hospital

location_facility: University of Occupational and Enviromental Health

location_facility: Synexus Affiliate - Sujata Birla Hospital & Medical Research Center

location_facility: Kasturba Medical College Hospital, Mangalore

location_facility: Napoca Emergency Clinical County Hospital

location_facility: Charlotte Maxeke Johannesburg Academic Hospital

location_facility: HPTU-El Hospital con alma Pablo Tobon Uribe

location_facility: Cincinnati Rheumatic Disease Study Group

location_facility: Johns Hopkins University School of Medicine

location_facility: Institute for Treatment and Rehabilitation Niska Banja

location_facility: Arizona Arthritis & Rheumatology Associates, P. C.

location_facility: Twoja Przychodnia Centrum Medyczne Nowa Sol

location_facility: Centro Integral de Reumatologia e Inmunologia

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Glacier View Research Institute - Endocrinology

location_facility: Arizona Arthritis & Rheumatology Research

location_facility: Centre hospitalier universitaire de Haut Leveque

location_facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

location_facility: Ortopedyczno-Rehabilitacyjny Szpital Kliniczny UM w Poznaniu

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Angeles University Foundation and Medical Center

location_facility: Instituto de Investigaciones Clinicas Quilmes

location_facility: Sushruta Multispecialty Hospital & Research Center Pvt Ltd

location_facility: Aprillus Asistencia e Investigacion - Servicio de neurologia

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.

location_facility: Craiova Emergency Clinical County Hospital

location_facility: IR Medical Center S.A. Instituto de Reumatologia

location_facility: Seoul National University Bundang Hospital

location_facility: Box Arthritis & Rheumatology of the Carolinas, PLLC

location_facility: Sociedad Medica Del Aparato Locomotor SA

location_facility: Comite de Etica en Investigacion - CEMIC

location_facility: Inland Rheumatology & Osteoporosis Medical Group

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: ChanRe Rheumatology And Immunology Center And Research

location_facility: Suite 509 Umhlanga Netcare Medical Centre

location_facility: Arthritis and Osteoporosis Associates of New Mexico

location_facility: Articularis Healthcare d/b/a/ Low Country Rheumatology, PA

location_facility: The Catholic University of Korea-Seoul St. Mary's Hospital

location_facility: Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej

location_facility: Integral Rheumatology & Immunology Specialists

location_facility: Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk


title: A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Who Completed the SIDEROS Study

acronym: SIDEROS-E

summary: The purpose of the study is to assess the long-term safety and efficacy of idebenone in patients with Duchenne muscular dystrophy (DMD) who completed the SIDEROS study.

ReferenceType: background

ReferenceCitation: Buyse GM, Voit T, Schara U, Straathof CSM, D'Angelo MG, Bernert G, Cuisset JM, Finkel RS, Goemans N, McDonald CM, Rummey C, Meier T; DELOS Study Group. Efficacy of idebenone on respiratory function in patients with Duchenne muscular dystrophy not using glucocorticoids (DELOS): a double-blind randomised placebo-controlled phase 3 trial. Lancet. 2015 May 2;385(9979):1748-1757. doi: 10.1016/S0140-6736(15)60025-3. Epub 2015 Apr 20.

ReferenceCitation: McDonald CM, Meier T, Voit T, Schara U, Straathof CS, D'Angelo MG, Bernert G, Cuisset JM, Finkel RS, Goemans N, Rummey C, Leinonen M, Spagnolo P, Buyse GM; DELOS Study Group. Idebenone reduces respiratory complications in patients with Duchenne muscular dystrophy. Neuromuscul Disord. 2016 Aug;26(8):473-80. doi: 10.1016/j.nmd.2016.05.008. Epub 2016 May 12.

ReferenceCitation: Buyse GM, Voit T, Schara U, Straathof CS, D'Angelo MG, Bernert G, Cuisset JM, Finkel RS, Goemans N, Rummey C, Leinonen M, Mayer OH, Spagnolo P, Meier T, McDonald CM; DELOS Study Group. Treatment effect of idebenone on inspiratory function in patients with Duchenne muscular dystrophy. Pediatr Pulmonol. 2017 Apr;52(4):508-515. doi: 10.1002/ppul.23547. Epub 2016 Aug 29.

ReferenceCitation: Mayer OH, Leinonen M, Rummey C, Meier T, Buyse GM; DELOS Study Group. Efficacy of Idebenone to Preserve Respiratory Function above Clinically Meaningful Thresholds for Forced Vital Capacity (FVC) in Patients with Duchenne Muscular Dystrophy. J Neuromuscul Dis. 2017;4(3):189-198. doi: 10.3233/JND-170245.

lead_sponsor: Santhera Pharmaceuticals

location_country:
Spain
Italy
Austria
United Kingdom
Switzerland
United States
France
Belgium
Germany

location_facility: Great Ormond Street Hospital for Children

location_facility: Center for Integrative Rare Disease Research, Rare Disease Research, LLC

location_facility: Hospital La Fe de Valencia Avinguda de Fernando Abril Martorell Servicio de Neurologia Torre D

location_facility: Reparto Di Neurologia dell'Osperdale Di Padova

location_facility: Children's Hospital Boston, Harvard Medical School, Department of Neurology

location_facility: Hospital Sant Joan de Deu Neuropediatra, Unidad de patologia nueromuscular, Servicio de Neurologia

location_facility: Robert Jones and Agnes Hunt Orthopaedic Hospital

location_facility: Centro Clinico NEMO (NEuroMuscular Omnicentre), Niguarda Hospital

location_facility: Hôpital Hôtel Dieu, Service Explorations Fonctionnelles - Centre de Référence de Maladies Neuromusculaires rares

location_facility: Scientific Coordinator Nemo Sud Clinical CenterAOU Policlinico "G. Martino"

location_facility: I-Motion - Plateforme d'essais cliniques pédiatriques Hôpital Armand Trousseau bâtiment Lemariey porte 20, 2ème étage

location_facility: Banner University of Arizona Medical Center

location_facility: Center for neuromuscular disorders, Universitäts-Kinderspital beider Basel (UKBB)

location_facility: Neurosciences Institute, Neurology - Charlotte Carolinas Healthcare System

location_facility: Dipartimento di Clinica Neurologica e Psichiatrica dell'Eta Evolutiva della Fondazione IRCCS "C. Mondino" di Pavia

location_facility: Servizio di Cardiomiologia e Genetica Medica AOU Università degli Studi della Campania Luigi Vanvitelli

location_facility: Clinical Research Facility Level 6 Leazes Wing Royal Victoria Infirmary

location_facility: University Medical Center Hamburg - Eppendorf, Department of Paediatrics

location_facility: U.O. Malattie Neuromuscolari, Istituto Giannina Gaslini

location_facility: Gillette Children's Specialty Healthcare

location_facility: University of Alabama - Birmingham, Child Health Research

location_facility: UCL, National Hospital for Neurology and Neurosurgery

location_facility: Center for neuromuscular disorders, Dr. v. Haunersche Kinderklinik, Universität München

location_facility: UC Davis Department of Physical Medicine and Rehabilitation

location_facility: University of Iowa, Department of Pediatrics

location_facility: Hôpital des enfants, Pédiatrie Neurologie et infectiologie Pôle enfants

location_facility: Children's Hospital of Philadelphia, Division of Pulmonology

location_facility: Service de neuropédiatrie Pôle Pédiatrie CHRU de Lille - Hôpital Jeanne de Flandre

location_facility: CHRU de Montpellier - Hôpital Gui de Chauliac, Département de pédiatrie - neuropédiatrie


title: A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines

location_country:
Croatia
Spain
United States
Peru
South Africa
Czechia
Poland
Austria
Russian Federation
Argentina
Puerto Rico
India
Turkey
Malaysia
Singapore
Sweden
Brazil
Canada
Guatemala
Hungary
Germany
Bulgaria
Denmark
Greece
Oman
Thailand
Korea, Republic of
France
Colombia

summary:
The purpose of this study is to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo.

The study population will consist of approximately 1050 male and female subjects aged ≥ 12 years who have been diagnosed with CSU and who remain symptomatic despite the use of H1-antihistamines. Of these, approximately 1000 adults and 50 adolescents are planned for inclusion in the study.

This is a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There is a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.


location_country:
Spain
Italy
United Kingdom
United States
Romania
Philippines
Belgium
Japan
Poland
Russian Federation
Australia
Argentina
Tunisia
India
Israel
Mexico
Slovakia
Brazil
Lebanon
Germany
Taiwan
Estonia
Finland
Vietnam
France
Chile
Netherlands

summary:
The purpose of this study was to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remained symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo.

The study population consisted of 1,079 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines.

This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.


title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis

acronym: SPIRIT

summary: The primary objective of this study is to evaluate the efficacy of BG00011 compared with placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). The secondary objectives of this study are: to evaluate the efficacy of BG00011 compared with placebo in participants with IPF as determined by change in percent predicted forced (expiratory) vital capacity (FVC); to assess progression-free survival in participants who receive BG00011 compared with placebo; to assess the occurrence of IPF exacerbation in participants who receive BG00011 compared with placebo; to assess the incidence of absolute decline in FVC ≥10% in participants who receive BG00011 compared with placebo; to assess the time to death or lung transplantation in participants who receive BG00011 compared with placebo, and the transplant-free survival rate at Week 26 and Week 52; to assess the time to non-elective hospitalizations in participants who receive BG00011 compared with placebo; to assess additional pulmonary function test (PFT) findings in participants who receive BG00011 compared with placebo; To assess performance on the 6 minute walk test (6MWT) in participants who receive BG00011 compared with placebo; to evaluate the safety and tolerability of BG00011; and to evaluate the serum concentration of BG00011.

ReferenceCitation: Raghu G, Mouded M, Chambers DC, Martinez FJ, Richeldi L, Lancaster LH, Hamblin MJ, Gibson KF, Rosas IO, Prasse A, Zhao G, Serenko M, Novikov N, McCurley A, Bansal P, Stebbins C, Arefayene M, Ibebunjo S, Violette SM, Gallagher D, Behr J. A Phase IIb Randomized Clinical Study of an Anti-α(v)β(6) Monoclonal Antibody in Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2022 Nov 1;206(9):1128-1139. doi: 10.1164/rccm.202112-2824OC.

ReferenceCitation: Shenderov K, Collins SL, Powell JD, Horton MR. Immune dysregulation as a driver of idiopathic pulmonary fibrosis. J Clin Invest. 2021 Jan 19;131(2). pii: 143226. doi: 10.1172/JCI143226. Review.

lead_sponsor: Biogen

location_country:
Denmark
Poland
Spain
Greece
Italy
Australia
Russian Federation
Argentina
United Kingdom
Korea, Republic of
United States
Chile
France
Israel
Belgium
Netherlands
Czechia

location_facility:
Reserach Site
Research Site


acronym: AD Up

title: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

lead_sponsor: AbbVie

ReferenceCitation: Silverberg JI, Simpson EL, Calimlim BM, Litcher-Kelly L, Li X, Sun X, Leshem YA. Determining Severity Strata for Three Atopic Dermatitis Patient-Reported Outcome Questionnaires: Defining Severity Score Ranges for the Worst Pruritus Numerical Rating Scale and the Atopic Dermatitis Symptom and Impact Scales (ADerm-SS and ADerm-IS). Dermatol Ther (Heidelb). 2022 Nov 4. doi: 10.1007/s13555-022-00836-5. [Epub ahead of print]

ReferenceCitation: Mendes-Bastos P, Ladizinski B, Guttman-Yassky E, Jiang P, Liu J, Prajapati VH, Simpson EL, Vigna N, Teixeira HD, Barbarot S. Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials. J Am Acad Dermatol. 2022 Oct;87(4):784-791. doi: 10.1016/j.jaad.2022.06.012. Epub 2022 Jun 15.

ReferenceCitation: Reich K, Teixeira HD, de Bruin-Weller M, Bieber T, Soong W, Kabashima K, Werfel T, Zeng J, Huang X, Hu X, Hendrickson BA, Ladizinski B, Chu AD, Silverberg JI. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021 Jun 5;397(10290):2169-2181. doi: 10.1016/S0140-6736(21)00589-4. Epub 2021 May 21. Erratum in: Lancet. 2021 Jun 19;397(10292):2336. Lancet. 2021 Aug 28;398(10302):746.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Hong Kong
Austria
Australia
Puerto Rico
Israel
Norway
Sweden
Slovakia
Canada
Hungary
China
Germany
Greece
Ireland
New Zealand
France
Netherlands

location_facility: Northwestern University Feinberg School of Medicine /ID# 201646

location_facility: Dermatology Research Institute Inc. /ID# 200341

location_facility: Hospital Universitario 12 de Octubre /ID# 201135

location_facility: Hospital Universitario La Paz /ID# 205438

location_facility: Tokai University Hachioji Hospital /ID# 201711

location_facility: Beth Israel Deaconess Medical Center /ID# 200545

location_facility: Michigan Center for Research Company /ID# 200560

location_facility: 401 GSNA - 401 Army General Hospital /ID# 211963

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202256

location_facility: Florida Academic Centers Research and Education /ID# 200544

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202093

location_facility: Universitetssykehuset N-Norge, Harstad /ID# 201269

location_facility: The Centre for Clinical Trials /ID# 205404

location_facility: Chinese PLA General Hospital /ID# 206786

location_facility: A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200742

location_facility: Advanced Clinical Research - Woseth Dermatology /ID# 213745

location_facility: Sahlgrenska University Hospital /ID# 201274

location_facility: Dartmouth-Hitchcock Medical Center /ID# 200918

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 205780

location_facility: Hospital Universitario de la Princesa /ID# 201517

location_facility: Fakultna nemocnica s poliklinikou Nove Zamky /ID# 204240

location_facility: Progressive Clinical Research /ID# 201582

location_facility: Universitaetsklinikum Muenster /ID# 202094

location_facility: Vital Prospects Clinical Research Institute, PC /ID# 200901

location_facility: Dermatology Physicians of Connecticut /ID# 201004

location_facility: Arlington Research Center, Inc /ID# 200559

location_facility: Guy's and St Thomas' NHS Foundation Trust /ID# 201193

location_facility: Guy's and St Thomas' NHS Foundation Trust /ID# 204642

location_facility: Clinical Research of West Florida, Inc /ID# 203643

location_facility: Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628

location_facility: Juntendo University Hospital /ID# 202888

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 204372

location_facility: Total Skin and Beauty Derm Ctr /ID# 200548

location_facility: The First Hospital of China Medical University /ID# 209840

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 209567

location_facility: Duplicate_Vseobecna Fakultni Nemocnice /ID# 205248

location_facility: St George Dermatology & Skin Cancer Centre /ID# 204788

location_facility: Eastern Canada Cutaneous Resea /ID# 200335

location_facility: Rivergate Dermatology & Skin Care Center /ID# 201698

location_facility: NHS Greater Glasgow and Clyde /ID# 201374

location_facility: Universitair Medisch Centrum Utrecht /ID# 202194

location_facility: CHRU Tours - Hopital Gatien de Clocheville /ID# 218209

location_facility: IMTR - Grand Hopital de Charleroi /ID# 202029

location_facility: Tel Aviv Sourasky Medical Center /ID# 201608

location_facility: Colorado Center for Dermatology, PLLC /ID# 203626

location_facility: Skane University Hospital Lund /ID# 201244

location_facility: Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403

location_facility: Huashan Hospital of Fudan University /ID# 207437

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 202045

location_facility: University Hospital Waterford /ID# 201253

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 201765

location_facility: GCM Medical Group PSC - Hato Rey /ID# 202003

location_facility: Advanced Dermatology and Skin Care Centre /ID# 213550

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 206669

location_facility: Epiphany Dermatology of Kansas LLC /ID# 203026

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205194

location_facility: Papageorgiou General Hospital Thessaloniki /ID# 202392

location_facility: Hospital General Universitario Alicante /ID# 200873

location_facility: Hospital Santa Creu i Sant Pau /ID# 201325

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 204144

location_facility: University General Hospital Attikon /ID# 201126

location_facility: The Chaim Sheba Medical Center /ID# 201611

location_facility: Osaka Habikino Medical Center /ID# 204243

location_facility: South Infirmary Victoria University Hospital /ID# 201079

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 203014

location_facility: Duplicate_Western States Clinical Research, Inc. /ID# 201702

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 200744

location_facility: Karolinska University Hospital /ID# 201243

location_facility: Arizona Research Center, Inc. /ID# 200546

location_facility: Medizinische Hochschule Hannover /ID# 202098

location_facility: Bakersfield Derma & Skin Cance /ID# 200892

location_facility: Children's Hosp P. A. Kyriakou /ID# 217573

location_facility: AP-HM - Hopital de la Timone /ID# 206128

location_facility: Clear Dermatology & Aesthetics Center /ID# 201257

location_facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 200330

location_facility: Jichi Medical University Hospital /ID# 201913

location_facility: Clinical Research Puerto Rico /ID# 203644

location_facility: General Hospital Andreas Syggros /ID# 201123

location_facility: Angela Montgomery Medicine Professional Corporation /ID# 212653

location_facility: CMS3 Company for Medical Study /ID# 205195

location_facility: Soroka University Medical Center /ID# 206652

location_facility: Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 204373

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 202052

location_facility: Therapeutics Clinical Research /ID# 200593

location_facility: Queens Square Medical Center dermatology allergology /ID# 203850

location_facility: Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822

location_facility: Oregon Dermatology and Research Center /ID# 200601

location_facility: Xiangya Hospital Central South University /ID# 207510

location_facility: Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 217866

location_facility: Universitetssykehuset N-Norge, Tromso /ID# 201270

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 207132

location_facility: Northshore University Health System Dermatology Clinical Trials Unit /ID# 200556

location_facility: Center for Clinical Studies - Webster TX /ID# 203186

location_facility: Psoriasis Treatment Center of Central New Jersey /ID# 200714

location_facility: Sanatorium profesora Arenbergera /ID# 202082

location_facility: Universitaetsklinikum Frankfurt /ID# 202095

location_facility: Yamate Dermatological Clinic /ID# 202130

location_facility: Hospital Universitario de Puerto Real /ID# 200875

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 207442

location_facility: Medizinische Universitaet Innsbruck /ID# 210897

location_facility: Medical Corporation Matsuo Clinic /ID# 202312

location_facility: National Hospital Organization Sagamihara National Hospital /ID# 201658

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 201106

location_facility: Medizinische Universitaet Wien /ID# 201080

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 200751

location_facility: Universitair Medisch Centrum Groningen /ID# 202195

location_facility: Kepler Universitaetsklinikum GmbH /ID# 201075

location_facility: Thessaloniki Hospital of Skin and Venereal Diseases /ID# 201124

location_facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 206728

location_facility: Universitaetsklinik Heidelberg /ID# 202097

location_facility: Dermatology Associates of Seattle /ID# 200717

location_facility: Haukeland University Hospital /ID# 201152

location_facility: University of California Irvine /ID# 200902

location_facility: Univerzitna nemocnica Martin /ID# 203851

location_facility: University of Wisconsin - Madison /ID# 204933

location_facility: Clin Res Inst of Michigan, LLC /ID# 208020

location_facility: Hiroshima University Hospital /ID# 201914

summary: The objective of this study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.