type: Other Grant/Funding Number

type: U.S. NIH Grant/Contract

title: A Phase II/III Randomized, Double-Blind, Placebo-Controlled, Cognitive Endpoint, Multi-Center Study of Potential Disease Modifying Therapies in Individuals at Risk for and With Dominantly Inherited Alzheimer's Disease

acronym: DIAN-TU

summary:
The purpose of this study is to assess the safety, tolerability, biomarker and cognitive efficacy of investigational products in subjects who are known to have an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive impairment and improves disease-related biomarkers.

This is an analysis study for an MPRP: DIAN-TU-001 Master NCT01760005

status: Completed

study_completion_date_type: Actual

ReferenceType: background

ReferenceCitation: Bateman RJ, Xiong C, Benzinger TL, Fagan AM, Goate A, Fox NC, Marcus DS, Cairns NJ, Xie X, Blazey TM, Holtzman DM, Santacruz A, Buckles V, Oliver A, Moulder K, Aisen PS, Ghetti B, Klunk WE, McDade E, Martins RN, Masters CL, Mayeux R, Ringman JM, Rossor MN, Schofield PR, Sperling RA, Salloway S, Morris JC; Dominantly Inherited Alzheimer Network. Clinical and biomarker changes in dominantly inherited Alzheimer's disease. N Engl J Med. 2012 Aug 30;367(9):795-804. doi: 10.1056/NEJMoa1202753. Epub 2012 Jul 11. Erratum in: N Engl J Med. 2012 Aug 23;367(8):780.

ReferenceCitation: Farlow M, Arnold SE, van Dyck CH, Aisen PS, Snider BJ, Porsteinsson AP, Friedrich S, Dean RA, Gonzales C, Sethuraman G, DeMattos RB, Mohs R, Paul SM, Siemers ER. Safety and biomarker effects of solanezumab in patients with Alzheimer's disease. Alzheimers Dement. 2012 Jul;8(4):261-71. doi: 10.1016/j.jalz.2011.09.224. Epub 2012 Jun 5.

ReferenceCitation: Bateman RJ, Benzinger TL, Berry S, Clifford DB, Duggan C, Fagan AM, Fanning K, Farlow MR, Hassenstab J, McDade EM, Mills S, Paumier K, Quintana M, Salloway SP, Santacruz A, Schneider LS, Wang G, Xiong C; DIAN-TU Pharma Consortium for the Dominantly Inherited Alzheimer Network. The DIAN-TU Next Generation Alzheimer's prevention trial: Adaptive design and disease progression model. Alzheimers Dement. 2017 Jan;13(1):8-19. doi: 10.1016/j.jalz.2016.07.005. Epub 2016 Aug 29.

ReferenceCitation: Mills SM, Mallmann J, Santacruz AM, Fuqua A, Carril M, Aisen PS, Althage MC, Belyew S, Benzinger TL, Brooks WS, Buckles VD, Cairns NJ, Clifford D, Danek A, Fagan AM, Farlow M, Fox N, Ghetti B, Goate AM, Heinrichs D, Hornbeck R, Jack C, Jucker M, Klunk WE, Marcus DS, Martins RN, Masters CM, Mayeux R, McDade E, Morris JC, Oliver A, Ringman JM, Rossor MN, Salloway S, Schofield PR, Snider J, Snyder P, Sperling RA, Stewart C, Thomas RG, Xiong C, Bateman RJ. Preclinical trials in autosomal dominant AD: implementation of the DIAN-TU trial. Rev Neurol (Paris). 2013 Oct;169(10):737-43. doi: 10.1016/j.neurol.2013.07.017. Epub 2013 Sep 6. Review.

ReferenceCitation: Wang G, Berry S, Xiong C, Hassenstab J, Quintana M, McDade EM, Delmar P, Vestrucci M, Sethuraman G, Bateman RJ; Dominantly Inherited Alzheimer Network Trials Unit. A novel cognitive disease progression model for clinical trials in autosomal-dominant Alzheimer's disease. Stat Med. 2018 Sep 20;37(21):3047-3055. doi: 10.1002/sim.7811. Epub 2018 May 14.

ReferenceCitation: Weninger S, Carrillo MC, Dunn B, Aisen PS, Bateman RJ, Kotz JD, Langbaum JB, Mills SL, Reiman EM, Sperling R, Santacruz AM, Tariot PN, Welsh-Bohmer KA. Collaboration for Alzheimer's Prevention: Principles to guide data and sample sharing in preclinical Alzheimer's disease trials. Alzheimers Dement. 2016 May;12(5):631-2. doi: 10.1016/j.jalz.2016.04.001.

ReferenceCitation: Grill JD, Bateman RJ, Buckles V, Oliver A, Morris JC, Masters CL, Klunk WE, Ringman JM; Dominantly Inherited Alzheimer's Network. A survey of attitudes toward clinical trials and genetic disclosure in autosomal dominant Alzheimer's disease. Alzheimers Res Ther. 2015 Jul 22;7(1):50. doi: 10.1186/s13195-015-0135-0. eCollection 2015.

ReferenceCitation: McDade E, Bateman RJ. Stop Alzheimer's before it starts. Nature. 2017 Jul 12;547(7662):153-155. doi: 10.1038/547153a.

ReferenceCitation: McDade E, Wang G, Gordon BA, Hassenstab J, Benzinger TLS, Buckles V, Fagan AM, Holtzman DM, Cairns NJ, Goate AM, Marcus DS, Morris JC, Paumier K, Xiong C, Allegri R, Berman SB, Klunk W, Noble J, Ringman J, Ghetti B, Farlow M, Sperling RA, Chhatwal J, Salloway S, Graff-Radford NR, Schofield PR, Masters C, Rossor MN, Fox NC, Levin J, Jucker M, Bateman RJ; Dominantly Inherited Alzheimer Network. Longitudinal cognitive and biomarker changes in dominantly inherited Alzheimer disease. Neurology. 2018 Oct 2;91(14):e1295-e1306. doi: 10.1212/WNL.0000000000006277. Epub 2018 Sep 14.

ReferenceCitation: Ryman DC, Acosta-Baena N, Aisen PS, Bird T, Danek A, Fox NC, Goate A, Frommelt P, Ghetti B, Langbaum JB, Lopera F, Martins R, Masters CL, Mayeux RP, McDade E, Moreno S, Reiman EM, Ringman JM, Salloway S, Schofield PR, Sperling R, Tariot PN, Xiong C, Morris JC, Bateman RJ; Dominantly Inherited Alzheimer Network. Symptom onset in autosomal dominant Alzheimer disease: a systematic review and meta-analysis. Neurology. 2014 Jul 15;83(3):253-60. doi: 10.1212/WNL.0000000000000596. Epub 2014 Jun 13. Review.

ReferenceCitation: Weng H, Bateman R, Morris JC, Xiong C. Validity and power of minimization algorithm in longitudinal analysis of clinical trials. Biostat Epidemiol. 2017;1(1):59-77. doi: 10.1080/24709360.2017.1331822. Epub 2017 Jun 13.

ReferenceCitation: Atkins KJ, Evered L, Scott DA, Fowler C, Masters CL, Silbert B. Cerebrospinal fluid sampling for research of Alzheimer's disease and other neurodegenerative diseases when lumbar punctures are performed by anaesthetists. BMJ Neurol Open. 2022 Sep 5;4(2):e000335. doi: 10.1136/bmjno-2022-000335. eCollection 2022.

ipd_sharing_description: Access to DIAN-TU trial data will follow the DIAN-TU data access policy, which complies with the guidelines established by the Collaboration for Alzheimer's Prevention [CAP REF].

lead_sponsor: Washington University School of Medicine

location_country:
Spain
Ireland
United Kingdom
Australia
Canada
Puerto Rico
United States
France

location_facility: The McCuster Foundation of Alzheimer's Disease Research

location_facility: University of California San Diego Medical Center

location_facility: University of Puerto Rico, School of Medicine

location_facility: Hospital Clínic I Provincial de Barcelona

location_facility: The National Hospital for Neurology and Neurosurgery

lead_sponsor_type: academique

status_simplified: Completed


title: A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately Active Ulcerative Colitis

acronym: GLADIATOR UC

summary: The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Arena Pharmaceuticals

location_country:
Poland
Portugal
Belarus
Spain
Italy
Georgia
Australia
Russian Federation
Canada
Ukraine
Hungary
Korea, Republic of
United States
France
Israel
Belgium
Germany
Bulgaria
Czechia

location_facility: Melbourne Health, The Royal Melbourne Hospital

location_facility: Washington University School of Medicine

location_facility: CNE Kyiv City Clinical Hospital #1 of Executive Body of Kyiv City Council (Kyiv City State Administration), Dept of Therapy #2

location_facility: Gastrointestinal Biosciences Clinical Trials, LLC

location_facility: Acibadem City Clinic University Hospital EOOD

location_facility: UCI Health H.H. Chao Comprehensive Digestive Disease Center

location_facility: London Health Sciences Centre- University Hospital

location_facility: Diagnostic Consultation Center CONVEX EOOD

location_facility: Coral Sea Clinical Research Institute Pty.Ltd

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Belgyogyaszati Klinika Gasztroenterologiai Osztaly

location_facility: Ivano-Frankivsk regional clinical hospital

location_facility: Endoexpert Egészségügyi Szolgáltató Kft.

location_facility: Health Care Institution "Vitebsk Regional Clinical Specialized Center"

location_facility: Gut P.C., dba Digestive Health Specialists

location_facility: LTD Malkhaz Katsiashvili Multiprofile Emergency Medicine Center

location_facility: JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

location_facility: University of Utah Hospitals and Clinics

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: MGG Group Co., Inc, Chevy Chase Clinical Research

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel

location_facility: Centre Hospitalier Universitaire de Genoble Alpes - CHU Michallon

location_facility: CNE Prof. O.O. Shalimov City Clinical Hospital #2 of Kharkiv City Council, Department of Proctology

location_facility: CRC - Centro Ricerche Cliniche di Verona

location_facility: Communal Non-commercial Medical Enterprise O.T. Bohaievskyi Kremenchuk First City Hospital, Therapeutic Department #2

location_facility: Centro Hospitalar Universitario de Sao Joao, E.P.E.

location_facility: Scientific and Research Institute of Invalid Rehabilitation of National Pirogov

location_facility: CNE "Vinnytsia Reg Clinical Hosp Named After Pirogov Vinnystsia Regoinal Council", Reg Specialized Clinical Center of Gastro

location_facility: Institution "Gomel Regional Clinical Hospital"

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Medical Center of LLC Health Clinic, Med Clinical Investigational Center, Unit of Gastroenterology, Hepatology and Endocrinology

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Gasztroenterologia

location_facility: Baylor College of Medicine - Baylor Medical Center

location_facility: Hospital General Universitario de Alicante

location_facility: Severance Hospital, Yonsei University Health System

location_facility: ASST Rhodense U.O.C di Gastroenterologia ed Endoscopia Digestiva

location_facility: UCSD Clinical and Translational Research Institute

location_facility: Diagnostic-Consultative Center I - Sliven, EOOD

location_facility: Communal Non-commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council, Department of Gastroenterology

location_facility: UO di Medicina Interna e Gastroenterologia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS-CEMAD Centro

location_facility: University of Calgary - Heritage Medical Research Clinic

location_facility: Gastroenterology Department, Rabin Medical Center

location_facility: Saint Petersburg State Medical University

location_facility: McGill University Health Center - Montreal General Hospital

location_facility: Centre Hospitalier Universitaire de Nice - Hopital de l'Archet2

location_facility: LTD Academician Nikoloz Kipshideze Central University Clinic

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: University multiprofile hospital for active treatment and emergency medicine N.I. Pirogov EAD

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Centre Hospitalier Universitaire de Nantes - Hotel-Dieu

location_facility: LTD Israeli-Georgian Medical Research Clinic Helsicore

location_facility: Semmelweis Egyetem Belgyogyaszati es Hematologiai Klinika

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: CNE Andrii Novak Transcarpathian Regional Clinical Hospital of Transcarpathian Reg Council, Department of Gastroenterology

location_facility: Autonomous Noncommercial Medical Organization "Stavropol Regional Clinical Advisory-Diagnostic Centre"

location_facility: Allmedica Badania Kliniczne Sp. z.o.o. Sp.k.

location_facility: Health Care Institution "Grodno City Clinical Hospital #4"

location_facility: Nizhniy Novgorod Regional Clinical Hospital

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: Azienda Ospedaliera Saverio De Bellis, Gastroenterologia II

location_facility: EuroMediCare Szpital Specjalistyczny z Przychodnia

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand-Hopital Estaing

location_facility: Private Institution, Educational Organization of Higher Education "Medical University Reaviz"

location_facility: Ospedale San Bortolo-UOC di Gastroenterologia Vicenza

location_facility: Municipal Enterprise Dnipro Reg Council,Dept of Gastro (Hepatology)

location_facility: IRCCS Ospedale, San Raffaele, Unita di Gastroenterologia

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


ipd_sharing: Yes

status: Active, not recruiting

primary_purpose: Prevention

acronym: GRACE

intervention_type: Biological

title: A Phase III, Randomized, Double-blind, Placebo-controlled Multi-country Study to Demonstrate Efficacy of a Single Dose of Unadjuvanted RSV Maternal Vaccine, Administered IM to Pregnant Women 18 to 49 Years of Age, for Prevention of RSV Associated LRTIs in Their Infants up to 6 Months of Age

lead_sponsor: GlaxoSmithKline

type: EudraCT Number

source: euctr

ReferenceType: derived

ReferenceCitation: Ginsburg AS, Srikantiah P. Respiratory syncytial virus: promising progress against a leading cause of pneumonia. Lancet Glob Health. 2021 Dec;9(12):e1644-e1645. doi: 10.1016/S2214-109X(21)00455-1. Epub 2021 Nov 11.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

enrollment_type: Actual

location_country:
Spain
Italy
United Kingdom
Honduras
United States
Belgium
Philippines
South Africa
Australia
Argentina
India
Panama
Mexico
Brazil
Canada
Bangladesh
Taiwan
Dominican Republic
New Zealand
Finland
Thailand
Korea, Republic of
France
Colombia

summary:
The purpose of this study is to evaluate the ability of a single dose of the investigational RSV Maternal vaccine, administered intramuscularly (IM) to pregnant women aged 18-49 years, in good general maternal health, in preventing medically assessed RSV associated Lower Respiratory Tract Illnesses (LRTIs) in infants born to vaccinated mothers. The study will also evaluate the safety of the investigational RSV Maternal vaccine both in vaccinated mothers and in their corresponding infant.

Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study. Ongoing study participants will continue to be monitored as part of the study.


type: Other Identifier

title: A Phase 1 Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations

summary: This is an open-label, multi-center Phase 1 study of LY3410738, an oral, covalent IDH inhibitor, in patients with IDH1 and/or IDH2-mutant advanced hematologic malignancies who may have received standard therapy

design_allocation: Non-Randomized

lead_sponsor: Eli Lilly and Company

location_country:
Taiwan
Spain
Australia
Finland
Canada
Korea, Republic of
United States
France
Israel
Singapore
Belgium
Germany

location_facility: University of North Carolina at Chapel Hill

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)

location_facility: University of California, Davis - Health Systems

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Centre hospitalier universitaire de Haut Leveque

location_facility: Hospital Universitario Fundación Jiménez Díaz


title: A Phase 2b, Open-label, Single-arm, Multi-centre Study Assessing the Efficacy and Safety of Adavosertib as Treatment for Recurrent or Persistent Uterine Serous Carcinoma

acronym: ADAGIO

summary: This Phase 2b study aims to evaluate the efficacy and safety of adavosertib, an inhibitor of the tyrosine kinase WEE1, in subjects with recurrent or persistent uterine serous carcinoma (USC) who have previously received at least 1 prior platinum-based chemotherapy regimen for the management of USC.

ReferenceCitation: Liu J, Oza AM, Colombo N, Oaknin A. ADAGIO: a phase IIb international study of the Wee1 inhibitor adavosertib in women with recurrent or persistent uterine serous carcinoma. Int J Gynecol Cancer. 2022 Jan;32(1):89-92. doi: 10.1136/ijgc-2021-003144. Epub 2021 Oct 29.

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.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
Canada
United States
France


title: A Phase 2, Randomized, Open-label Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Hepatocellular Carcinoma Who Are Naive to IO Therapy But Progressed on Tyrosine Kinase Inhibitors (RELATIVITY-073)

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Taiwan
Brazil
Hong Kong
Romania
Spain
Russian Federation
Australia
Mexico
Argentina
New Zealand
Korea, Republic of
France
Chile
China
Turkey
Colombia
Japan
Singapore
Czechia

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica

location_facility: Unidade de Pesquisa Clínica do Hospital da Clínicas de Ribeirão Preto-Clinical Oncology

location_facility: Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia

summary: The purpose of this study is to evaluate the effectiveness and safety of relatlimab in combination with nivolumab in participants with advanced liver cancer who have never been treated with immuno-oncology therapy, after prior treatment with tyrosine kinase inhibitor therapy.


title: A Modular Phase 2a Multicentre Open-Label Study to Investigate DNA-damage Response Agents (or Combinations) in Patients With Advanced Cancer Whose Tumours Contain Molecular Alterations (PLANETTE)

summary: The study is investigating efficacy, safety and tolerability of DNA-damage Response Agents (or Combinations), in participants with advanced/metastatic solid malignancies whose tumours contain molecular alterations

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

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

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
United States
Spain
France


title: A Phase 2, Randomized, Open-Label, Multicenter Study to Evaluate Safety and Efficacy of Single Agent Selinexor Versus Treatment of Physician's Choice in Patients With Previously Treated Myelofibrosis

summary: This is a Phase 2, multicenter, two-arm, open-label study to evaluate the safety and efficacy of selinexor versus treatment per physician's choice (PC) in participants with myelofibrosis (MF) who had at least 6 months of treatment with a Janus kinase (JAK)1/2 inhibitor. Study participants will be randomized in a 1:1 ratio to either receive selinexor or physicians' choice of treatment.

ipd_sharing: Undecided

lead_sponsor: Karyopharm Therapeutics Inc

location_country:
Poland
Spain
Greece
Italy
Hungary
United States
France
China

location_facility: General Hospital of Athens "EVAGGELISMOS"

location_facility: Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Saint-Louis - Centre d'Investigations Cliniques (CIC)

location_facility: Nanfang Hospital of Southern Medical University

location_facility: Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

location_facility: South Pest Central Hospital, National Inst. Hematol. Inf. Dis.

location_facility: Affiliated Hospital of Nantong University

location_facility: Sir Run Run Shaw Hospital - Zhejiang University School of Medicine

location_facility: Suzhou University -The First Affiliated Hospital

location_facility: Asst Settelaghi, Ospedale Di Circolo E Fondazione Macchi

location_facility: Sorbonne Universites - Centre De Recherche Saint Antoine (CRSA)

location_facility: University of Perugia Department of Medicine Hematology Section

location_facility: Aou Policlinico S. Orsola - UO Ematologia

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga

location_facility: Università degli Studi di Firenze - Azienda Ospedaliero - Universitaria Careggi - Dipartimento di medicina sperimentale e clinica

location_facility: Tianjin Cancer Hospital Airport Hospital

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

location_facility: Centre Hospitalier Universitaire d'Angers (CHU Angers)

location_facility: Azienda Unita Sanitaria Locale Latina - Ospedale Santa Maria Goretti

intervention_type: Other


acronym: Ravulizumab in Pediatric Participants with TMA after HSCT

title: A Phase 3, Open-label, Single Arm, Multicenter Study of Ravulizumab in Addition to Best Supportive Care in Pediatric Participants With Thrombotic Microangiopathy (TMA) After Hematopoietic Stem Cell Transplantation (HSCT)

lead_sponsor: Alexion Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
Korea, Republic of
United States
Israel
France
Japan

location_facility:
Clinical Study Site
Clinical Trial Site

summary: This study will evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of ravulizumab administered by intravenous infusion to pediatric participants, from 1 month to < 18 years of age, with HSCT-TMA. The treatment period is 26 weeks, followed by a 26-week off-treatment follow-up period.


title: A Phase 3b Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

lead_sponsor: Vertex Pharmaceuticals Incorporated

ReferenceCitation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12:CD010966. doi: 10.1002/14651858.CD010966.pub3.

ipd_sharing_description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

location_country:
Denmark
Spain
United Kingdom
Australia
Netherlands
Canada
Switzerland
France
Israel
Germany

location_facility: Charite Paediatric Pulmonology Department

location_facility: University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital

location_facility: Universitatsklinikum Essen (AoR), Kinderklinik III, Abt. fur Pneumologie

location_facility: McGill University Health Centre, Glen Site, Montreal Children's Hospital

location_facility: Universitaetsklinikum Heidelberg, Zenter fuer Kinder-und Jugendmedizin

location_facility: Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital

location_facility: Erasmus Medical Center / Sophia Children's Hospital

location_facility: Groupe Hospitaler Pellegrin, CHU De Bordeaux

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Justus-Liebig-Universität Gießen Zentrum fur Kinderheilkunde und Jugendmedizin

location_facility: Hadassah University Hospital Mount Scopus

location_facility: Great Ormond Street Hospital for Sick Children

location_facility: Schneider Children's Medical Center of Israel

summary: This study will evaluate the long-term safety and efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination (TC) in subjects with CF who are 6 years of age and older with F/MF genotypes.


title: A Phase 3, Randomized, Double-blind, Multicenter, Placebo Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease

summary: This study aims to define the efficacy and safety of inebilizumab for the prevention of flare of IgG4-related disease (IgG4-RD).

lead_sponsor: Viela Bio (acquired by Horizon Therapeutics)

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Japan
Poland
Hong Kong
Australia
Argentina
India
Israel
Turkey
Mexico
Sweden
Canada
Hungary
China
Germany
Ireland
France
Netherlands

location_facility:
Viela Bio Investigative Site 3
Viela Bio Investigative Siite
Viela Bio Investigative Site 5
Viela Bio Investigative Site 1
Viela Bio Investigative Site
Viela Bio Investigative Site 2
Viela Bio Investigative Site 4


title: A Double-Blind, Vehicle-Controlled, Randomized Withdrawal and Treatment Extension Study to Assess the Long-Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo

summary: The purpose of this study is to evaluate the duration of response following withdrawal of ruxolitinib cream (Cohort A vehicle group), safety and maintenance of response with continued use of ruxolitinib cream in participants who have completed either Study NCT04052425 or NCT04057573 (parent studies) in which the participants will have been using ruxolitinib cream BID for the previous 28 to 52 weeks depending on their initial randomization in the parent study.

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Poland
Spain
Netherlands
Canada
United States
France
Germany
Bulgaria

location_facility: Delricht Clinical Research - Clinedge - Ppds Baton Rouge

location_facility: Simcoderm Medical and Surgical Dermatology Center

location_facility: International Clinical Research Tennessee Llc

location_facility: Synexus - Polska Sp Z Oo Oddzial W Gdansk

location_facility: Synexus Polska Sp. Z O.O. Oddzial W Gdyni

location_facility: Synexus Affiliate - Krakowskie Centrum Medyczne

location_facility: Synexus Polska Sp. Z O.O. Oddzial Warszawie

location_facility: Diagnostic Consultative Center Xxviii - Sofia - Eood

location_facility: Center For Dermatology Cosmetic and Laser Surgery

location_facility: Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume

location_facility: Forcare Clinical Research Fcr Forward Clinical Trials, Inc

location_facility: Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol

location_facility: Dermatology Associates of Plymouth Meeting

location_facility: Synexus Polska Sp. Z O.O. Oddzial W Poznaniu

location_facility: The Dermatology and Laser Center of San Antonio

location_facility: Synexus Polska Sp Z Oo Oddzial W Czestochowie

location_facility: Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu

location_facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

location_facility: Vitiligo & Pigmentation Institute of Southern California

location_facility: Poradnia Dermatologiczno-Wenerologiczna Mediderm S.C. Nzoz

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque

location_facility: University Multiprofile Hospital For Active Treatment Aleksandrovska

location_facility: Diagnostic Consultative Center Ii Sofia Eood


title: Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab With Adalimumab Reference Arm, in Children With Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

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.

location_country:
Denmark
Spain
Italy
United Kingdom
Mexico
Netherlands
Argentina
Switzerland
France
Belgium
Germany
Czechia

location_facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

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

location_facility: H.R.U Málaga - Hospital Materno-infantil

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: ASST Spedali Civili - Università degli Studi

location_facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Oxford University Hospitals - Nuffield Orthopaedic Centre

location_facility: UMC Utrecht - Wilhelmina Kinderziekenhuis

location_facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

location_facility: CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari

location_facility: Investigacion y Biomedicina de Chihuahua

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini

location_facility: Hôpital Arnaud de Villeneuve - CHU Montpellier

location_facility: Universitäts-Kinderspital beider Basel UKBB

location_facility: Queen's Medical Centre, Nottingham University Hospitals

location_facility: Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

summary: The reason for this study is to see if the study drug ixekizumab is safe and effective in children with juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) (including juvenile onset ankylosing spondylitis [JoAS]) and juvenile psoriatic arthritis (JPsA).


title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

lead_sponsor: Concert Pharmaceuticals

location_country:
Poland
Spain
Canada
United States
France

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: SimcoDerm Medical and Surgical Dermatology Center

location_facility: Clinical Research Trials of Florida, Inc.

location_facility: Austin Institute for Clinical Research, Inc.

location_facility: Colorado Center for Dermatology and Skin Surgery

location_facility: UC Irvine Dermatology Clinical Research Center

location_facility: Clinical Research Center of the Carolinas

location_facility: Hospital Clínico Y Provincial de Barcelona

location_facility: University of Minnesota Department of Dermatology

location_facility: Northwestern Memorial Hospital, Department of Dermatology

location_facility: Dermatology Associates Of Plymouth Meeting

location_facility: California Dermatology & Clinical Research Institute

location_facility: Clinical Investigation Specialists, Inc.

location_facility: Yale University, Church Street Research Unit

location_facility: Hôpital Saint Louis, Centre de Santé Sabouraud

location_facility: Dr Wei Jing Loo Medicine Professional Corporation

location_facility: Dr. S. K. Siddha Medicine Professional Corporation

location_facility: Dermatology Clinical Research Center of San Antonio

location_facility: Dermatology Treatment and Research Center

location_facility: Skin Laser and Surgery Specialists of NJ

location_facility: Total Skin and Beauty Dermatology Center

location_facility: Vital Prospects Clinical Research Institute, P.C.

location_facility: Wake Forest University Health Sciences, Department of Dermatology

summary: This is a multi-center Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). It is double-blinded, meaning that the Sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.


title: A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 8)

acronym: DREAMM 8

summary: This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide, bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple myeloma (RRMM).

location_country:
Poland
Spain
Greece
Italy
Australia
New Zealand
Canada
Russian Federation
United Kingdom
Korea, Republic of
United States
France
China
Israel
Turkey
Japan
Germany
Czechia


title: A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH)

location_country:
Poland
Taiwan
Brazil
Spain
Greece
Italy
Netherlands
United Kingdom
Canada
Thailand
Korea, Republic of
France
United States
Israel
Malaysia
Japan
Germany
Czechia

summary: The main objective of this study is to evaluate the efficacy of danicopan as add-on therapy to a complement component 5 (C5) inhibitor (eculizumab or ravulizumab) in participants with PNH who have clinically evident EVH.


title: A Phase 2b, Open-label, Single-arm Study of ZW25 Monotherapy in Subjects With Advanced or Metastatic HER2-amplified Biliary Tract Cancers

summary: This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or metastatic biliary tract cancer (BTC), including intra-hepatic cholangiocarcinoma (ICC), extra-hepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).

lead_sponsor: Zymeworks Inc.

location_country:
Spain
Italy
United Kingdom
Canada
Korea, Republic of
United States
Chile
China
France

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

location_facility: Washington University School of Medicine

location_facility: Hospital General Universitario Gregorio Marañón

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

location_facility: Institut de Cancerologie et d'Hematologie Hopital Morvan - CHRU de Brest

location_facility: Hospital Universitari Parc Tauli de Sabadell

location_facility: Fondazione del Piemonte per l'Oncologia (IRCCS)

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University College London Hospitals (UCLH)

location_facility: Pontificia Universidad Catolica de Chile

location_facility: Severance Hospital Yonsei University Health System

location_facility: Winship Cancer Institute, Emory University

location_facility: Affiliated Zhongshan Hospital of Fudan University

location_facility: Département Oncologie Gastro-entérologie CHRU de Poitiers La Miletrie

location_facility: The First Affiliated Hospital, Sun Yat-sen University

location_facility: The First Hospital Of Lanzhou University

location_facility: The Third Affiliated Hospital of the Chinese PLA

location_facility: Affiliated Tumor Hospital of Harbin Medical University

location_facility: The First Affiliated Hospital of Zhejiang University

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: The Oncology Institute of Hope and Innovation

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: University of Texas Southwestern Medical Center - Hospital

intervention_type: Diagnostic Test


title: Phase IIb, Placebo-Controlled, Randomized, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB®) Single Implantation in Tibial Fracture

summary:
Although the majority of tibial fractures heal normally, some fractures may not heal within the usual time frame and is known as delayed bone healing within 4 to 6 months and absence of bone healing within 9 to 12 months in the most severe case of. Several factors can increase the risks of delayed healing complications like, for example, smoking, violent shocks (for example, due to a road accident) or even the type of fracture (an open fracture). The location of the fracture is also an important factor: among the bones of the arms and legs, the tibia is known for being the most at risk for complications. At tibial fracture with several risk factors could lead to delayed complications and interfere with patient daily life and reduce the quality of life.

The study drug, ALLOB®, is constituted of bone cells produced from the bone marrow of healthy adult donors. Preclinical studies have shown that ALLOB® cells are capable of forming bone and repairing fractures. When directly injected into a fracture, ALLOB® should therefore promote the healing of the fracture by re-establishing a healthy environment and stimulating bone production. To date, there is no treatment for fractures considered at risk of delayed complications. The current practice on diagnosis of complications is to wait at least 6-12 months before considering alternative interventions to promote fracture healing. The injection of ALLOB® quickly after the fracture should stimulate bone healing, reduce healing time, reduce complications, and improve the quality of life for the patient. ALLOB® has already shown preliminary evidence of effectiveness in the treatment of delayed bone healing fractures (ALLOB-DU1 clinical trial), including tibial fractures (8 patients). With this study, the Sponsor will evaluate whether ALLOB® promotes the healing of tibial fractures compared with placebo.

lead_sponsor: Bone Therapeutics S.A

location_country: Poland Spain Hungary France Belgium Germany Czechia


title: A Randomized, Double-Blind, Adaptive, Phase II/III Study of GSK3359609 in Combination With Pembrolizumab and 5FU-Platinum Chemotherapy Versus Placebo in Combination With Pembrolizumab Plus 5FU-Platinum Chemotherapy for First-Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

location_country:
Denmark
Poland
Brazil
Romania
Spain
Ireland
Italy
Australia
Russian Federation
Argentina
Canada
United Kingdom
Sweden
Korea, Republic of
United States
France
Belgium
Japan
Germany

summary: The purpose of this study is to evaluate if the addition of GSK3359609 to pembrolizumab in combination with 5FU-platinum based chemotherapy improves the efficacy of the pembrolizumab combination with 5FU-platinum based chemotherapy in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). This randomized, double-blinded, Phase II/III study will compare the combination of GSK3359609 with pembrolizumab and 5FU-platinum chemotherapy to placebo in combination with pembrolizumab and 5FU-platinum chemotherapy in participants with recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx or larynx.


title: GLOBAL PREVALENCE OF TRANSTHYRETIN AMYLOID CARDIOMYOPATHY (ATTR-CM) IN PARTICIPANTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFpEF)

summary: This study is a global, multi-center study designed to estimate the global prevalence of transthyretin amyloid cardiomyopathy (ATTR-CM) within a clinically at risk population [participants with heart failure with preserved ejection fraction (HFpEF)].

primary_purpose: Screening

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Poland
Spain
Italy
United Kingdom
Canada
United States
France
Japan

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Cardiology Associates of North Mississippi, LLC

location_facility: U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS

location_facility: Fondazione Toscana Gabriele Monasterio-UOC Cardiologia e Medicina Cardiovascolare

location_facility: Fondazione IRCCS Policlinico San Matteo - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Łodzi Centralny Szpital

location_facility: Centre Hospitalier Saint-Joseph Saint-Luc

location_facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II

location_facility: St George's Hospital, St George's University Hospitals NHS Foundation Trust

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

location_facility: Providence Sacred Heart Medical Center and Children's Hospital


acronym: RUXCOVID

title: Phase 3 Randomized, Double-blind, Placebo-controlled Multi-center Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (RUXCOVID)

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Han MK, Antila M, Ficker JH, Gordeev I, Guerreros A, Bernus AL, Roquilly A, Sifuentes-Osornio J, Tabak F, Teijeiro R, Bandelli L, Bonagura DS, Shu X, Felser JM, Knorr B, Cao W, Langmuir P, Lehmann T, Levine M, Savic S. Ruxolitinib in addition to standard of care for the treatment of patients admitted to hospital with COVID-19 (RUXCOVID): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Rheumatol. 2022 May;4(5):e351-e361. doi: 10.1016/S2665-9913(22)00044-3. Epub 2022 Mar 29.

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

location_country:
Brazil
Spain
United Kingdom
Russian Federation
Mexico
Argentina
France
United States
Peru
Turkey
Colombia
Germany

summary: This was a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with placebo + SoC therapy, in patients aged ≥12 years with COVID-19 disease.


title: SOLIRIS® (Eculizumab) for the Treatment of Participants With Coronavirus Disease 2019 (COVID 19) - An Expanded Access Program for Hospital-based Emergency Treatment

summary: This protocol provides access to eculizumab treatment for participants with severe COVID-19.

status: No longer available

study_type: Expanded Access

ReferenceCitation: Burwick RM, Dellapiana G, Newman RA, Smithson SD, Naqvi M, Williams J 3rd, Wong MS, Bautista M, Gaden A, Kazani SD, Dunn DA, Ma MH, Mitter S, Monteleone JPR, Ortiz SR, Ghandehari S, Merin N, Zakowski MI, Karumanchi SA. Complement blockade with eculizumab for treatment of severe Coronavirus Disease 2019 in pregnancy: A case series. Am J Reprod Immunol. 2022 Aug;88(2):e13559. doi: 10.1111/aji.13559. Epub 2022 May 12.

location_country:
United States
France

location_facility: The Ohio State University Wexner Medical Center

status_simplified: Unknown


title: A Phase 3b, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

location_facility: Charite Paediatric Pulmonology Department

location_facility: University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital

location_facility: McGill University Health Centre, Glen Site, Montreal Children's Hospital

location_facility: Universitaetsklinikum Heidelberg, Zenter fuer Kinder-und Jugendmedizin

location_facility: Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital

location_facility: Erasmus Medical Center / Sophia Children's Hospital

location_facility: Groupe Hospitaler Pellegrin, CHU De Bordeaux

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Justus-Liebig-Universität Gießen Zentrum fur Kinderheilkunde und Jugendmedizin

location_facility: Hadassah University Hospital Mount Scopus

location_facility: Great Ormond Street Hospital for Sick Children

summary: This study will evaluate the efficacy and safety of elexacaftor (ELX) / tezacaftor (TEZ) / ivacaftor (IVA) triple combination (TC) in subjects 6 through 11 years of age with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function (MF) mutation (F/MF genotypes).


title: A Phase II, Safety, and Efficacy Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Patients With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer

lead_sponsor: Hoffmann-La Roche

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
Taiwan
Brazil
Spain
Italy
Russian Federation
Australia
United Kingdom
Canada
Thailand
Korea, Republic of
United States
Costa Rica
France
Panama
Mexico
Peru

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

location_facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque

location_facility: ICIMED Instituto de Investigación en Ciencias Médicas

location_facility: FSBI "National Medical Research Center of Oncology N.N. Blokhin"

location_facility: Szpital Morski im.PCK; Oddzial Onkologii Klinicznej, Oddzial Dzienny

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: IRCCS S. Raffaele; Ginecologia Oncologica

location_facility: Taichung Veterans General Hospital; Obstetrics and Gynecology

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: Hamilton Health Sciences - Juravinski Cancer Centre

location_facility: Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica

location_facility: Chelyabisnk regional clinical center for oncology and nuclear medicine

location_facility: Maharaj Nakorn Chiang Mai Hospital; Faculty of Medicine Chiangmai University

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: McGill University Health Centre - Glen Site

location_facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

location_facility: Murmansk Regional Clinical Hospital named after P.A. Bayandin

location_facility: Tomsk scientific research institute of oncology SO RAMN, PAD; Pathological

location_facility: Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej

location_facility: Mackay Memorial Hospital; Obstetrics & Gynaecology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: National Taiwan University Hospital; Obstetrics & Gynecology

location_facility: Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.

location_facility: Chang Gung Medical Foundation, Linkou Branch; Gynecologic Oncology

summary: The purpose of this study is to evaluate the efficacy and safety of tiragolumab in combination with atezolizumab and atezolizumab monotherapy in patients with programmed death-ligand 1 (PD-L1)-positive cervical cancer (metastatic and/or recurrent).


acronym: PHOENYCS GO

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

lead_sponsor: UCB Biopharma SRL

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Peru
Belgium
Philippines
Romania
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Argentina
Mexico
Canada
Hungary
Germany
Bulgaria
Taiwan
Greece
Korea, Republic of
France
Chile
Colombia

summary: The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.


title: A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe COVID-19

lead_sponsor: Gilead Sciences

ReferenceCitation: Goldman JD, Lye DCB, Hui DS, Marks KM, Bruno R, Montejano R, Spinner CD, Galli M, Ahn MY, Nahass RG, Chen YS, SenGupta D, Hyland RH, Osinusi AO, Cao H, Blair C, Wei X, Gaggar A, Brainard DM, Towner WJ, Muñoz J, Mullane KM, Marty FM, Tashima KT, Diaz G, Subramanian A; GS-US-540-5773 Investigators. Remdesivir for 5 or 10 Days in Patients with Severe Covid-19. N Engl J Med. 2020 Nov 5;383(19):1827-1837. doi: 10.1056/NEJMoa2015301. Epub 2020 May 27.

ReferenceCitation: Jacobson KB, Rao M, Bonilla H, Subramanian A, Hack I, Madrigal M, Singh U, Jagannathan P, Grant P. Patients With Uncomplicated Coronavirus Disease 2019 (COVID-19) Have Long-Term Persistent Symptoms and Functional Impairment Similar to Patients with Severe COVID-19: A Cautionary Tale During a Global Pandemic. Clin Infect Dis. 2021 Aug 2;73(3):e826-e829. doi: 10.1093/cid/ciab103.

ReferenceCitation: Olender SA, Perez KK, Go AS, Balani B, Price-Haywood EG, Shah NS, Wang S, Walunas TL, Swaminathan S, Slim J, Chin B, De Wit S, Ali SM, Soriano Viladomiu A, Robinson P, Gottlieb RL, Tsang TYO, Lee IH, Hu H, Haubrich RH, Chokkalingam AP, Lin L, Zhong L, Bekele BN, Mera-Giler R, Phulpin C, Edgar H, Gallant J, Diaz-Cuervo H, Smith LE, Osinusi AO, Brainard DM, Bernardino JI; GS-US-540-5773 and GS-US-540-5807 Investigators. Remdesivir for Severe Coronavirus Disease 2019 (COVID-19) Versus a Cohort Receiving Standard of Care. Clin Infect Dis. 2021 Dec 6;73(11):e4166-e4174. doi: 10.1093/cid/ciaa1041.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

location_country:
Taiwan
Hong Kong
Spain
Italy
United Kingdom
Netherlands
Switzerland
Sweden
Korea, Republic of
United States
France
China
Singapore
Japan
Germany

location_facility: Icahn School of Medicine at Mount Sinai, 350 East 17th Street

location_facility: Kaiser Permanente Oakland Medical Center, 2500 Merced St

location_facility: National Centre for Infectious Diseases, Tan Tock Seng Hospital

location_facility: Icahn School of Medicine at Mount Sinai, 1000 10th Avenue

location_facility: Klinikum St. Georg gGmbH Klinik fur Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie

location_facility: John H. Stroger Jr. Hospital of Cook County

location_facility: Robert Wood Johnson University Hospital Somerset, 201 Lyons Avenue

location_facility: Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue

location_facility: Kaiser Permanente Los Angeles Medical Center, 4647 Zion Avenue

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Klinik für Hämatologie, Onkologie, Immunologie

location_facility: Kaiser Sunnyside Medical Center, 2875 NW Stucki Ave

location_facility: Universitatsklinikum Dusseldorf, Klinik fur Gastroenterologie, Hepatologie und Infektiologie

location_facility: UOC Malattie Infettive ad Alta Intensita di Cure, Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.

location_facility: SCL Health St. Joseph Hospital, 1375 East 19th Ave

location_facility: Icahn School of Medicine at Mount Sinai, 440 West 114th St.

location_facility: Baylor University Medical Center, 1400 8th Ave

location_facility: Kaiser Permanente Oakland Medical Center, 700 Lawrence Expressway

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Providence St Patrick Hospital and International Heart Institute of MT Foundation

location_facility: Hospital of the University of Pennsylvania

location_facility: Columbia University Medical Center-New York Presbyterian Hospital

location_facility: UO Malattie Infettive, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Kaiser Permanente Los Angeles Medical Center, 9455 Clairemont Mesa Blvd

location_facility: UOC Medicina Di Laboratorio, Azienda Ospedaliera di Padova

location_facility: UOC Malattie Infettive, ASST Papa Giovanni XXIII

location_facility: ASST di Cremona - Azienda Socio Sanitaria Territor

location_facility: Sutter Medical Center Sacramento, One Medical Plaza

location_facility: UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 6201 Harry Hines Blvd

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Hull University Teaching Hospitals NHS Trust

location_facility: Kaiser Permanente Oakland Medical Center, 1200 El Camino Real

location_facility: Kaiser Permanente Oakland Medical Center, 2425 Geary Blvd

location_facility: Manchester University NHS Foundation Trust

location_facility: New York Presbyterian Hospital/Weill Cornell Medical Center

location_facility: Providence Regional Medical Center Everett

location_facility: Baylor University Medical Center, 2401 S. 31st St.

location_facility: Kaiser Permanente Los Angeles Medical Center, 9961 Sierra Ave

location_facility: Kaiser Permanente Los Angeles Medical Center, 27300 Iris Avenue

location_facility: UOC Malattie Infettive I, Fondazione IRCCS Policlinio San Matteo

location_facility: Hospital Regional Universitario de Málaga

location_facility: Kaiser Permanente Los Angeles Medical Center, 9333 Imperial Highway

location_facility: Kaiser Permanente Los Angeles Medical Center, 5601 De Soto Avenue

location_facility: Kaiser Permanente Oakland Medical Center, 250 Hospital Parkway, Suite 850

location_facility: University Hospitals Cleveland Medical Center

location_facility: UOC Malattie Infettive, IRCCS Ospedale San Raffaele

location_facility: California Pacific Medical Center-Infectious Disease Associates Medical Group

location_facility: Kaiser Permanente Hawaii Moanalua Medical Center

location_facility: The Liver Institute of Methodist Dallas Medical Center

location_facility: Dipartimento di Malattie Infettive, Malattie Infettive I- Malattie Infettive III, AssT Fatebenefratelli Sacco Ospedale Luigi Sacco

location_facility: Kaiser Permanente Oakland Medical Center

location_facility: Kaiser Permanente Los Angeles Medical Center, 2295 S. Vineyard Avenue

location_facility: Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave.

location_facility: The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange

location_facility: UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 5201 Harry Hines Blvd.

location_facility: Mission Hospital Regional Medical Center

location_facility: CHU de Montpellier-Hopital Gui de Chauliac

location_facility: University of Colorado Denver, University of Colorado Hospital

location_facility: Amsterdam University Medical Centre - Location AMC

location_facility: Kaiser Permanente Los Angeles Medical Center, 13651 Willard Street

location_facility: Robert Wood Johnson University Hospital Somerset, 1 RWJ Place

location_facility: Hospital of the University of Pennsylvania, 51 N. 31st Street

location_facility: Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum, Medizinische Klinik Infektiologie Pneumologie

location_facility: Kaiser Permanente Los Angeles Medical Center, 10800 Magnolia Avenue

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: James J. Peters Veterans Administration Medical Center

location_facility: Kaiser Permanente Los Angeles Medical Center, 6041 Cadillac Ave.

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel

location_facility: Ospedale Guglielmo da Saliceto AUSL di Piacenza

location_facility: The University of Michigan Hospitals and Health Systems

location_facility: Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia

location_facility: Brigham & Women's Hospital and Harvard Medical School

location_facility: Robert Wood Johnson University Hospital Somerset

location_facility: SCL Health St. Joseph Hospital, 200 Exempla Circle.

location_facility: Prisma Health Richland Hospital, 701 Grove Road

location_facility: Robert-Bosch-Krankenhaus (RBK), Klinik Schillerhohe (KSH) und Dr. Margarete Fischer-Bosch-Institut fur klinische Pharmakologie (IKP)

location_facility: North Shore University Hospital, 270-05 76th Ave

location_facility: Klinikum rechts der Isar der TU Munchen, Klinik und Poliklinik Innere Medizin 2

summary: The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.


title: A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate COVID-19 Compared to Standard of Care Treatment

ReferenceType: result

ReferenceCitation: Spinner CD, Gottlieb RL, Criner GJ, Arribas López JR, Cattelan AM, Soriano Viladomiu A, Ogbuagu O, Malhotra P, Mullane KM, Castagna A, Chai LYA, Roestenberg M, Tsang OTY, Bernasconi E, Le Turnier P, Chang SC, SenGupta D, Hyland RH, Osinusi AO, Cao H, Blair C, Wang H, Gaggar A, Brainard DM, McPhail MJ, Bhagani S, Ahn MY, Sanyal AJ, Huhn G, Marty FM; GS-US-540-5774 Investigators. Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2020 Sep 15;324(11):1048-1057. doi: 10.1001/jama.2020.16349.

ReferenceCitation: Ansems K, Grundeis F, Dahms K, Mikolajewska A, Thieme V, Piechotta V, Metzendorf MI, Stegemann M, Benstoem C, Fichtner F. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Aug 5;8:CD014962. doi: 10.1002/14651858.CD014962.

location_facility: Icahn School of Medicine at Mount Sinai, 350 East 17th Street

location_facility: Kaiser Permanente Oakland Medical Center, 2500 Merced St

location_facility: National Centre for Infectious Diseases, Tan Tock Seng Hospital

location_facility: NHS Lothian, Royal lnfirmary of Edinburgh

location_facility: Icahn School of Medicine at Mount Sinai, 1000 10th Avenue

location_facility: Malattie Infettive I, Fondazione IRCCS Policlinico San Matteo

location_facility: Klinikum St. Georg gGmbH Klinik fur Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie

location_facility: Robert Wood Johnson University Hospital Somerset, 201 Lyons Avenue

location_facility: UOC Malattie Infettive e Tropicali, Azienda Ospedaliera di Padova

location_facility: Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue

location_facility: Kaiser Permanente Los Angeles Medical Center, 4647 Zion Avenue

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center

location_facility: Klinik für Hämatologie, Onkologie, Immunologie

location_facility: Kaiser Sunnyside Medical Center, 2875 NW Stucki Ave

location_facility: Universitatsklinikum Dusseldorf, Klinik fur Gastroenterologie, Hepatologie und Infektiologie

location_facility: UOC Malattie Infettive ad Alta Intensita di Cure, Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.

location_facility: SCL Health St. Joseph Hospital, 1375 East 19th Ave

location_facility: Icahn School of Medicine at Mount Sinai, 440 West 114th St.

location_facility: Baylor University Medical Center, 1400 8th Ave

location_facility: Kaiser Permanente Oakland Medical Center, 700 Lawrence Expressway

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Kaiser Permanente Los Angeles Medical Center,27300 Iris Avenue

location_facility: Providence St Patrick Hospital and International Heart Institute of MT Foundation

location_facility: UO Malattie Infettive, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Kaiser Permanente Los Angeles Medical Center, 9455 Clairemont Mesa Blvd

location_facility: UOC Malattie Infettive, ASST Papa Giovanni XXIII

location_facility: ASST di Cremona - Azienda Socio Sanitaria Territor

location_facility: Weill Cornell Medical College/NYU Presbyterian Hospital

location_facility: Sutter Medical Center Sacramento, One Medical Plaza

location_facility: UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 6201 Harry Hines Blvd

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Kaiser Permanente Los Angeles Medical Center,13651 Willard Street

location_facility: Hull University Teaching Hospitals NHS Trust

location_facility: Kaiser Permanente Oakland Medical Center, 1200 El Camino Real

location_facility: Kaiser Permanente Oakland Medical Center, 2425 Geary Blvd

location_facility: Manchester University NHS Foundation Trust

location_facility: Baylor University Medical Center, 2401 S. 31st St.

location_facility: Kaiser Permanente Los Angeles Medical Center, 9961 Sierra Ave

location_facility: Hospital Regional Universitario de Málaga

location_facility: Kaiser Permanente Los Angeles Medical Center, 9333 Imperial Highway

location_facility: Kaiser Permanente Los Angeles Medical Center, 5601 De Soto Avenue

location_facility: Kaiser Permanente Oakland Medical Center, 250 Hospital Parkway, Suite 850

location_facility: University Hospitals Cleveland Medical Center

location_facility: UOC Malattie Infettive, IRCCS Ospedale San Raffaele

location_facility: California Pacific Medical Center-Infectious Disease Associates Medical Group

location_facility: Kaiser Permanente Hawaii Moanalua Medical Center

location_facility: The Liver Institute of Methodist Dallas Medical Center

location_facility: Kaiser Permanente Oakland Medical Center

location_facility: Kaiser Permanente Los Angeles Medical Center, 2295 S. Vineyard Avenue

location_facility: Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave.

location_facility: Columbia University Irving Medical Center

location_facility: The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange

location_facility: UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 5201 Harry Hines Blvd.

location_facility: Mission Hospital Regional Medical Center

location_facility: CHU de Montpellier-Hopital Gui de Chauliac

location_facility: University of Colorado Denver, University of Colorado Hospital

location_facility: Amsterdam University Medical Centre - Location AMC

location_facility: Robert Wood Johnson University Hospital Somerset, 1 RWJ Place

location_facility: Hospital of the University of Pennsylvania, 51 N. 31st Street

location_facility: Hospital Universitari i Politecnic La Fe

summary: The primary objective of this study was to evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with respect to clinical status assessed by a 7-point ordinal scale on Day 11.


title: Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

acronym: ADHERE+

summary: This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.

lead_sponsor: argenx

location_country:
Serbia
Spain
Italy
Ukraine
United States
Romania
Belgium
Japan
Czechia
Poland
Austria
Russian Federation
Israel
China
Germany
Bulgaria
Denmark
Latvia
Georgia
France
Netherlands

location_facility:
Investigator site 42
Investigator site 78
Investigator site 39
Investigator site 63
Investigator site 47
Investigator site 24
Investigator site 65
Investigator Site 7
Investigator site 86
Investigator site 2
Investigator site 13
Investigator site 9
Investigator site 85
Investigator site 76
Investigator site 55
Investigator site 56
Investigator site 92
Investigator site 75
Investigator site 96
Investigator site 80
Investigator site 68
Investigator site 69
Investigator site 20
Investigator site 12
Investigator site 51
Investigator site 16
Investigator Site 4
Investigator site 32
Investigator site 34
Investigator site 46
Investigator site 70
Investigator site 79
Investigator site 10
Investigator site 88
Investigator site 43
Investigator site 30
Investigator site 33
Investigator site 52
Investigator site 59
Investigator site 91
Investigator site 25
Investigator site 35
Investigator site 72
Investigator site 94
Investigator Site 5
Investigator site 27
Investigator site 23
Investigator site 95
Investigator site 82
Investigator site 54
Investigator site 26
Investigator site 67
Investigator site 90
Investigator site 15
Investigator site 50
Investigator site 73
Investigator site 87
Investigator site 11
Investigator site 44
Investigator site 22
Investigator site 31
Investigator site 40
Investigator site 60
Investigator site 66
Investigator site 37
Investigator site 45
Investigator site 74
Investigator site 28
Investigator site 93
Investigator site 62
Investigator site 41
Investigator Site 3
Investigator site 84
Investigator site 81
Investigator Site 6
Investigator site 38
Investigator site 61
Investigator site 83
Investigator site 58
Investigator site 77
Investigator site 71
Investigator site 14
Investigator site 89
Investigator site 53
Investigator site 19
Investigator site 17
Investigator site 21
Investigator site 18
Investigator site 8
Investigator site 49
Investigator site 29
Investigator site 1
Investigator site 64
Investigator site 48
Investigator site 57


title: DREAMM 7: A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared With the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants With Relapsed/Refractory Multiple Myeloma

acronym: DREAMM 7

summary: This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Brazil
Spain
Greece
Italy
Australia
Netherlands
Canada
New Zealand
Russian Federation
United Kingdom
Korea, Republic of
United States
France
China
Israel
Belgium
Japan
Germany
Czechia


title: A Phase I, Open-label, Parallel Group Study to Investigate Olaparib Safety and Tolerability, Efficacy and Pharmacokinetics in Paediatric Patients With Solid Tumours

summary: A study to find out whether olaparib is safe and well tolerated when administered to children and adolescents with solid tumours.

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:
Denmark
Poland
Spain
Italy
Russian Federation
Australia
United Kingdom
Canada
Ukraine
Hungary
Korea, Republic of
United States
France
Israel
Germany


title: Clinical Trial of Atrial Fibrillation Patients Comparing Left Atrial Appendage Occlusion Therapy to Non-vitamin K Antagonist Oral Anticoagulants

acronym: CATALYST

summary:
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy.

The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion.

lead_sponsor: Abbott Medical Devices

location_country:
Denmark
Poland
Hong Kong
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Switzerland
United States
France
Japan
Germany
Czechia

location_facility: Cardioangiologisches Centrum am Bethanien Krankenhaus

location_facility: CHI Health Creighton University Medical Center-Bergan Mercy

location_facility: Baylor All Saints Medical Center at Fort Worth

location_facility: Tennova Healthcare-Turkey Creek Medical Center

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)

location_facility: AdventHealth Florida Cardiology - Oviedo

location_facility: The University of Hong Kong (Queen Mary Hospital)

location_facility: Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

location_facility: Institute Cardio. Paris-Sud - Institut Jacques Cartier

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: St. Cloud Hospital - Central MN Heart Clinic

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Northside Hospital (CardioVascular Group Lawrenceville)

location_facility: University Hospital - Univ. of Alabama at Birmingham (UAB)

location_facility: Cardiovascular Research Institute of Kansas

location_facility: Kansas City Cardiac Arrhythmia Research Foundation

location_facility: AdventHealth Florida Cardiology - Altamonte Springs

location_facility: AdventHealth Florida Cardiology - Lake Mary

location_facility: CHI St. Luke's Health Baylor College of Medicine Med. Ctr.

location_facility: New York Presbyterian Hospital/Cornell University

intervention_type: Device


acronym: Phase 2 Study in 1L HNSCC of IT MK-1454 / MK-3475 IV vs MK-3475 IV

title: A Phase 2 Study in First Line Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma to Evaluate Intratumoral MK-1454 in Combination With IV Pembrolizumab vs IV Pembrolizumab Monotherapy

lead_sponsor: Merck Sharp & Dohme LLC

ReferenceCitation: McIntosh JA, Liu Z, Andresen BM, Marzijarani NS, Moore JC, Marshall NM, Borra-Garske M, Obligacion JV, Fier PS, Peng F, Forstater JH, Winston MS, An C, Chang W, Lim J, Huffman MA, Miller SP, Tsay FR, Altman MD, Lesburg CA, Steinhuebel D, Trotter BW, Cumming JN, Northrup A, Bu X, Mann BF, Biba M, Hiraga K, Murphy GS, Kolev JN, Makarewicz A, Pan W, Farasat I, Bade RS, Stone K, Duan D, Alvizo O, Adpressa D, Guetschow E, Hoyt E, Regalado EL, Castro S, Rivera N, Smith JP, Wang F, Crespo A, Verma D, Axnanda S, Dance ZEX, Devine PN, Tschaen D, Canada KA, Bulger PG, Sherry BD, Truppo MD, Ruck RT, Campeau LC, Bennett DJ, Humphrey GR, Campos KR, Maddess ML. A kinase-cGAS cascade to synthesize a therapeutic STING activator. Nature. 2022 Mar;603(7901):439-444. doi: 10.1038/s41586-022-04422-9. Epub 2022 Mar 16.

location_country:
Brazil
Spain
United Kingdom
Austria
Australia
Korea, Republic of
United States
France
Israel
Norway

location_facility: Royal Marsden NHS Foundation Trust ( Site 0031)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 0114)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0064)

location_facility: Monash Health-Monash Medical Centre ( Site 0041)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0078)

location_facility: Sanford Cancer Center Oncology Clinic ( Site 0014)

location_facility: University of California at San Francisco ( Site 0006)

location_facility: Hospital Clinico de Barcelona ( Site 0116)

location_facility: Hospital de Caridade de Ijui ( Site 0061)

location_facility: Calvary Central Districts Hospital ( Site 0042)

location_facility: Ordensklinikum Linz Gmbh - Barmherzige Schwestern ( Site 0051)

location_facility: Centro Regional Integrado de Oncologia ( Site 0062)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 0085)

location_facility: Royal Marsden Hospital Sutton-Surrey ( Site 0032)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0058)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0115)

location_facility: Allgemeines Krankenhaus der Stadt Wien ( Site 0049)

location_facility: Haukeland Universitetssykehus, Klinisk forskningspost voksne ( Site 0086)

summary:
The purpose of this study is to assess the efficacy and safety of intratumoral (IT) ulevostinag in PLUS pembrolizumab (MK-3475) compared to pembrolizumab alone as a first line treatment of adults with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

The primary study hypotheses are that IT ulevostinag in combination with pembrolizumab results in a superior Objective Response Rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), compared to pembrolizumab alone:

in participants with a tumor that has a programmed cell death-ligand 1 (PD-L1) Combined Positive Scoring (CPS) ≥ 1, and
in participants with a tumor that has a PD-L1 CPS ≥ 20.


title: A Multi-center, Double-blinded and Open-label Extension Study to Evaluate the Efficacy and Safety of Ligelizumab as Retreatment, Self-administered Therapy and Monotherapy in Chronic Spontaneous Urticaria Patients Who Completed Studies CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Peru
Belgium
Japan
Philippines
Romania
South Africa
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Tunisia
Puerto Rico
India
Israel
Turkey
Mexico
Malaysia
Singapore
Slovakia
Brazil
Lebanon
Canada
Guatemala
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Oman
Estonia
Thailand
Vietnam
Korea, Republic of
France
Chile
Colombia
Netherlands

summary:
The purpose of this extension study was to establish efficacy and safety of ligelizumab. This was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. In a subset of subjects, the safety and efficacy of ligelizumab monotherapy was assessed.

This study also fulfills the Novartis commitment to provide post-trial access to patients who have completed studies CQGE031C2302, CGQE031C2303, CQGE031C2202 or CQGE031C1301.


title: Evaluation of Efficacy, Safety and Tolerability of NGM282 (Aldafermin) in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (ALPINE 4)

summary: A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis.

lead_sponsor: NGM Biopharmaceuticals, Inc

location_country:
Poland
Hong Kong
Spain
United Kingdom
Australia
Puerto Rico
United States
France
Belgium
Germany


title: MasterKey-01: A Phase 1/2, Open-label, Two-part, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics & Antitumor Activity of BDTX-189, an Inhibitor of Allosteric ErbB Mutations, in Patients w/ Advanced Solid Malignancies

summary:
This is a clinical study with an orally administered drug, BDTX-189 in participants with advanced solid tumors that have select mutations or alterations in human epidermal growth factor receptor 2 (HER2/ErbB2) genes or epidermal growth factor receptor (EGFR/ErbB1). The main goals of this study are to:

Find the recommended dose of BDTX-189 that can be given safely to participants
Learn more about the side effects of BDTX-189
Learn what the body does to BDTX-189 after it has been taken (pharmacokinetics or PK)
Determine the antitumor activity of BDTX-189 in participants with select allosteric ErbB gene mutations

status: Terminated

ReferenceCitation: Erika Paige Hamilton, Manish R. Patel, Jordi Rodon, David S. Hong, Alison M. Schram, Pasi A. Janne, Patricia LoRusso, Jasgit C. Sachdev, Sai Hong Ou, Elizabeth A Buck, Matthew O'Connor, Nigel Waters, Karsten Witt, Carl Cook. Masterkey-01: Phase I/II, open-label multicenter study to assess safety, tolerability, pharmacokinetics, and antitumor activity of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies. J Clin Oncol 38: 2020 (suppl; abstr TPS3665)

lead_sponsor: Black Diamond Therapeutics, Inc.

location_country:
Denmark
United States
Spain
France


title: A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010).

type: Registry Identifier

ReferenceCitation: Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.

location_country:
Poland
Taiwan
Brazil
Spain
Italy
Russian Federation
Australia
United Kingdom
Canada
Hungary
Korea, Republic of
United States
France
China
Peru
Mexico
Japan
Germany
Turkey

location_facility: The Third Affiliated Hospital of Harbin Medical University ( Site 3302)

location_facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 0701)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2506)

location_facility: National Cancer Center Hospital ( Site 1102)

location_facility: Medipol Universite Hastanesi ( Site 2800)

location_facility: ASST Santi Paolo e Carlo - Presidio Ospedaliero San Paolo ( Site 2405)

location_facility: Peking Union Medical College Hospital ( Site 3304)

location_facility: National Cancer Center Hospital East ( Site 1100)

location_facility: Universitaetsklinikum Frankfurt ( Site 2107)

location_facility: Wuhan Union hospital Cancer Center ( Site 3307)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 2200)

location_facility: Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 2508)

location_facility: National Cheng Kung University Hospital ( Site 1603)

location_facility: University of Colorado Cancer Center ( Site 0023)

location_facility: California Cancer Associates for Research & Excellence ( Site 0059)

location_facility: Hospital Universitario 12 de Octubre ( Site 2702)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 2507)

location_facility: Tokyo Medical and Dental University Hospital ( Site 1101)

location_facility: Washington University School of Medicine ( Site 0060)

location_facility: Trakya Universitesi Tip Fakultesi ( Site 2801)

location_facility: Hospital Universitario La Paz ( Site 2706)

location_facility: Dana Farber Cancer Institute ( Site 0019)

location_facility: Fundacao Sao Francisco Xavier ( Site 0409)

location_facility: Fujian Provincial Cancer Hospital ( Site 3326)

location_facility: Hospital Nacional Arzobispo Loayza ( Site 0703)

location_facility: Tongji Hospital Tongji Medical,Science & Technology ( Site 3316)

location_facility: Orszagos Onkologiai Intezet ( Site 2202)

location_facility: Universitaetsklinikum Regensburg ( Site 2100)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 2804)

location_facility: Memorial Regional Hospital-Memorial Cancer Institute ( Site 0069)

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0053)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0002)

location_facility: California Cancer Associates for Research & Excellence ( Site 0025)

location_facility: Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 2803)

location_facility: Altay Regional Oncology Dispensary ( Site 2611)

location_facility: Seoul National University Bundang Hospital ( Site 1205)

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2502)

location_facility: Providence Portland Medical Center ( Site 0048)

location_facility: Georgia Cancer Center at Augusta University ( Site 0013)

location_facility: IEO Istituto Europeo di Oncologia ( Site 2406)

location_facility: Hospital Clinico Universitario Lozano Blesa ( Site 2703)

location_facility: Northwest Georgia Oncology Centers PC ( Site 0028)

location_facility: University of Louisville, James Graham Brown Cancer Center ( Site 0045)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 2605)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 0700)

location_facility: St. Vincent Frontier Cancer Center ( Site 0008)

location_facility: Yokohama City University Hospital ( Site 1104)

location_facility: Hiroshima University Hospital ( Site 1109)

location_facility: Chonnam National University Hwasun Hospital ( Site 1202)

location_facility: Christie NHS Foundation Trust ( Site 2903)

location_facility: Taunton and Somerset Hospital ( Site 2900)

location_facility: Hospital Nacional Edgardo Rebagliati Martins ( Site 0702)

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0602)

location_facility: ASL Liguria 2 - Ospedale San Paolo ( Site 2401)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 1111)

location_facility: Universitätsklinikum Leipzig-Department for ENT ( Site 2106)

location_facility: Oaxaca Site Management Organization S.C. ( Site 0603)

location_facility: SUNY Upstate Medical University ( Site 0051)

location_facility: McGill University Health Centre ( Site 0206)

location_facility: Inova Schar Cancer Institute ( Site 0009)

location_facility: Taipei Veterans General Hospital ( Site 1601)

location_facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2504)

location_facility: Royal Marsden NHS Foundation Trust ( Site 2910)

location_facility: University of North Carolina- Chapel Hill ( Site 0056)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2609)

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 2509)

location_facility: Weill Cornell Medicine New York Presbyterian Hospital ( Site 0040)

location_facility: Medical Park Izmir Hospital ( Site 2807)

location_facility: University of Connecticut Health Center ( Site 0020)

location_facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

location_facility: Christus Muguerza Clinica Vidriera ( Site 0607)

location_facility: Aichi Cancer Center Hospital ( Site 1113)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Glowy i Szyi ( Site

location_facility: National Taiwan University Hospital ( Site 1600)

location_facility: Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 0604)

location_facility: University of Wisconsin- Madison Carbone Cancer Center ( Site 0006)

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 2402)

location_facility: Tianjin Medical University Cancer Hospital ( Site 3312)

location_facility: Universitaetsklinikum Koeln ( Site 2111)

location_facility: Szegedi Egyetem Szent-Gyorgyi Albert Klinikai Kozpont ( Site 2207)

location_facility: Hospital Nacional Cayetano Heredia ( Site 0704)

location_facility: Guangxi Medical University Affiliated Tumor Hospital ( Site 3322)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1604)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2400)

location_facility: Princess Margaret Cancer Centre ( Site 0200)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 2206)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 1105)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 3328)

location_facility: Fudan University Shanghai Cancer Center ( Site 3324)

location_facility: Hacettepe Universitesi Tip Fakultesi ( Site 2805)

location_facility: Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0414)

location_facility: Keimyung University Dongsan Hospital ( Site 1203)

location_facility: The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 1204)

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce

location_facility: University of Kansas Cancer Center ( Site 0033)

location_facility: Xiangya Hospital of Central South University ( Site 3305)

location_facility: The Cancer Institute Hospital of JFCR ( Site 1103)

location_facility: Universitaetsklinikum Tuebingen ( Site 2108)

location_facility: Cryptex Investigación Clínica S.A. de C.V. ( Site 0608)

location_facility: West China Hospital of Sichuan University ( Site 3308)

location_facility: Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 2112)

summary:
This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.

Hypotheses include:

Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR.
Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).


acronym: Heads UP

title: A Phase 3b, Open-Label Treatment Extension Study of Upadacitinib For the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis Who Completed Treatment in Study M16-046

lead_sponsor: AbbVie

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, analyses plans, 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:
Croatia
Spain
Italy
United Kingdom
Ukraine
United States
Czechia
Poland
Australia
Israel
Norway
Malaysia
Singapore
Canada
Hungary
Germany
Taiwan
Ireland
New Zealand
Finland
France
Netherlands

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214221

location_facility: Miami Dermatology and Laser Institute /ID# 218664

location_facility: Hospital Universitario de Bellvitge /ID# 214257

location_facility: Hospital Pakar Sultanah Fatimah /ID# 218877

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 218959

location_facility: Allergy, Asthma & Immunology Associates, PC /ID# 218548

location_facility: Kyiv City Clinical Skin and Venereal Hospital /ID# 218382

location_facility: Dr. Chih-ho Hong Medical Inc. /ID# 218725

location_facility: Universitatsklinikum Munster /ID# 214222

location_facility: University Hospitals Sussex NHS Foundation Trust /ID# 213562

location_facility: Nemocnice Jihlava, prispevkova organizace /ID# 214178

location_facility: Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 218879

location_facility: Clinical Research Partners, LLC /ID# 218480

location_facility: Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 218376

location_facility: Oulun yliopistollinen sairaala /ID# 214628

location_facility: National University Hospital /ID# 219093

location_facility: CHU Toulouse - Hopital Larrey /ID# 218958

location_facility: The Royal Free London NHS Foundation Trust /ID# 213560

location_facility: Hospital Universitario Arnau Vilanova /ID# 214254

location_facility: St Vincent's University Hospital /ID# 213558

location_facility: The Chaim Sheba Medical Center /ID# 218522

location_facility: Dermatology Research Institute Inc. /ID# 218728

location_facility: ClinicMed Daniluk, Nowak Sp.j. /ID# 214299

location_facility: Medical University of South Carolina /ID# 221072

location_facility: DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 218377

location_facility: Keski-pohjanmaa Central Hospital /ID# 214630

location_facility: Clinical Research Trials of Florida, Inc. /ID# 218438

location_facility: Oregon Medical Res Center PC /ID# 218440

location_facility: Universitair Medisch Centrum Utrecht /ID# 218771

location_facility: Michigan Center for Research Company /ID# 218577

location_facility: Clinical Research Solutions, LLC /ID# 218447

location_facility: Oregon Health and Science University /ID# 218578

location_facility: ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 218385

location_facility: Wellington Regional Hospital /ID# 218689

location_facility: Dermatology Research Associates /ID# 218637

location_facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 218724

location_facility: National Taiwan University Hospital /ID# 218917

location_facility: Niakosari Medicine Professional Corporation /ID# 218729

location_facility: Azienda Ospedaliero-Universitaria di Modena /ID# 214096

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 214984

location_facility: NHS Greater Glasgow and Clyde /ID# 213561

location_facility: Beacon Clinical Research, LLC /ID# 218636

location_facility: Dermatologische Gemeinschaftspraxis Mahlow /ID# 214225

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214095

location_facility: Universitetssykehuset N-Norge, Tromso /ID# 214634

location_facility: Fakultni nemocnice Hradec Kralove /ID# 214176

location_facility: Dermoklinika Centrum Medyczne s.c. /ID# 214300

location_facility: Georgia Pollens Clinical Research Centers, Inc /ID# 218441

location_facility: Taipei Municipal Wan Fang Hospital /ID# 218918

location_facility: Sneeze, Wheeze, & Itch Associates, LLC /ID# 218552

location_facility: Hospital Universitario Dr. Negrin /ID# 214256

location_facility: Dr. Wei Jing Loo Medicine Prof /ID# 218722

location_facility: Klinika Ambroziak Sp. z o.o. /ID# 214301

location_facility: California Allergy and Asthma Medical Group /ID# 218635

location_facility: Klinicki bolnicki centar Zagreb /ID# 218375

location_facility: Medical Dermatology Associates of Chicago /ID# 218551

location_facility: China Medical University Hospital /ID# 218409

location_facility: University Hospitals Case Medical Center /ID# 218574

location_facility: Royalderm Agnieszka Nawrocka /ID# 214302

location_facility: Medizinische Hochschule Hannover /ID# 214226

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 214093

location_facility: University of Arkansas for Medical Sciences /ID# 221021

location_facility: Complejo Hospitalario Universitario de Pontevedra /ID# 214255

location_facility: Universitair Medisch Centrum Groningen /ID# 218775

location_facility: AP-HM - Hopital de la Timone /ID# 218957

location_facility: Holdsworth House Medical Practice /ID# 218755

location_facility: Hospital Universitario y Politecnico La Fe /ID# 214252

location_facility: Florida International Rsrch cr /ID# 218663

location_facility: Universitaetsklinikum Frankfurt /ID# 214223

location_facility: Chung Shan Medical University Hospital /ID# 218919

summary:
This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completed.

Main objective of this study is to assess long-term safety, tolerability and efficacy of upadacitinib in participants with moderate to severe atopic dermatitis who successfully completed treatment in the study M16-046.