title: postMONARCH: A Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy

acronym: postMONARCH

summary: This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond.

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Poland
Hungary
Argentina
Denmark
Israel
Sweden
Mexico
Belgium
United States
Korea, Republic of
Spain
Greece
Turkey
Taiwan
Czechia
France

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Tennessee Oncology-Chattanooga /Sarah Cannon Research Institute/SCRI

location_facility: COI Tijuana - Centro Oncológico Internacional

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

location_facility: The University of Vermont Medical Center Inc.

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi

location_facility: Europejskie Centrum Zdrowia - Oddzial Onkologii

location_facility: Dana-Farber Cancer Institute - Foxborough

location_facility: Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan

location_facility: Centro de Investigacion en Artritis y Osteoporosis SC

location_facility: Torrance Memorial Physician Network / Cancer Care

location_facility: P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: TRIO-US (Translational Research in Oncology-US)

location_facility: Fundación Cenit Para La Investigación En Neurociencias

location_facility: Rocky Mountain Cancer Center - Hale Parkway

location_facility: Tennessee Oncology-Nashville/Sarah Cannon Research Institute/SCRI

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: Seoul National University Bundang Hospital

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: Kapiolani Medical Center for Women and Children

location_facility: Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Florida Cancer Specialists EAST/Sarah Cannon Research Institute/SCRI

location_facility: Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego

location_facility: University General Hospital of Heraklion

location_facility: Dana Farber Cancer Center Merrimack Valley

location_facility: University of Miami Hospital and Clinics, Sylvester Cancer Center

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

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

location_facility: Hematology Oncology Clinic- Baton Rouge/Sarah Cannon Research Institute/SCRI

location_facility: Winship Cancer Institute, Emory University

location_facility: Maryland Oncology Hematology, P.A. - Clinton

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Chang Gung Medical Foundation-Linkou Branch


type: EudraCT Number

title: Phase I Open-label, Dose Escalation Trial of BI 1831169 Monotherapy and in Combination With Ezabenlimab in Patients With Advanced or Metastatic Solid Tumors

summary:
This study is open to adults with different types of advanced cancer (solid tumours) that are accessible for injection. People for whom previous treatment was not successful or for whom no other treatment options exist can join the study.

The study tests a medicine called BI 1831169 alone and in combination with another medicine called ezabenlimab. BI 1831169 and ezabenlimab may help the immune system fight cancer. In this study, BI 1831169 is given to people for the first time.

The study has 2 parts. The purpose of the first part is to find the highest dose of BI 1831169 the participants can tolerate. Part 1 also tests whether BI 1831169 can make the tumours shrink. The purpose of the second part is to find the highest dose of BI 1831169 in combination with ezabenlimab that the participants can tolerate.

Participants get BI 1831169 as an injection into the tumour, or as an infusion into the vein, or both (injection and infusion). Ezabenlimab is given as an infusion into a vein. Participants get the medicines about every 3 weeks.

Participants who get BI 1831169 alone receive this treatment for up to 3 months. Participants who take the combination treatment, get BI 1831169 for up to 3 months and ezabenlimab for up to a year. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by BI 1831169 or ezabenlimab.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Porosnicu M, Quinson AM, Crossley K, Luecke S, Lauer UM. Phase I study of VSV-GP (BI 1831169) as monotherapy or combined with ezabenlimab in advanced and refractory solid tumors. Future Oncol. 2022 Aug;18(24):2627-2638. doi: 10.2217/fon-2022-0439. Epub 2022 Jun 14.

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Future Science Ltd

ipd_sharing: No

ipd_sharing_description:
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

studies in products where Boehringer Ingelheim is not the license holder;
studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Austria
Belgium
United States
Spain
France

location_facility: University of Iowa Hospitals and Clinics

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Physician-initiated, International, Multi-center, Retrospective and Prospective, Observational Registry of Patients Treated by Preloaded Fenestrated Stent-graft Designs for Complex Endovascular Aortic Procedures

summary:
The aim of the study is to evaluate the outcomes of the preloaded stent-graft design (PLD) in the routine treatment of para-renal and thoraco-abdominal aneurysms. Results and postoperative events are reported in accordance with the current reporting standards for endovascular aortic repair prepared and revised by the Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American Association for Vascular Surgery.

The Registry will include approximately 300 patients treated from January 2015 to May 2021 (retrospective arm) and June 2021 to June 2023 (perspective arm) for the routine treatment of para-renal and thoraco-abdominal aneurysms. To reach 300 patients, the enrollments can be extended until June 2026.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Other

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Greenberg RK, West K, Pfaff K, Foster J, Skender D, Haulon S, Sereika J, Geiger L, Lyden SP, Clair D, Svensson L, Lytle B. Beyond the aortic bifurcation: branched endovascular grafts for thoracoabdominal and aortoiliac aneurysms. J Vasc Surg. 2006 May;43(5):879-86; discussion 886-7. doi: 10.1016/j.jvs.2005.11.063.

ReferenceCitation: Mohabbat W, Greenberg RK, Mastracci TM, Cury M, Morales JP, Hernandez AV. Revised duplex criteria and outcomes for renal stents and stent grafts following endovascular repair of juxtarenal and thoracoabdominal aneurysms. J Vasc Surg. 2009 Apr;49(4):827-37; discussion 837. doi: 10.1016/j.jvs.2008.11.024. Epub 2009 Feb 23.

ReferenceCitation: Manning BJ, Harris PL, Hartley DE, Ivancev K. Preloaded fenestrated stent-grafts for the treatment of juxtarenal aortic aneurysms. J Endovasc Ther. 2010 Aug;17(4):449-55. doi: 10.1583/10-3024.1.

ReferenceCitation: Kitagawa A, Greenberg RK, Eagleton MJ, Mastracci TM. Zenith p-branch standard fenestrated endovascular graft for juxtarenal abdominal aortic aneurysms. J Vasc Surg. 2013 Aug;58(2):291-300. doi: 10.1016/j.jvs.2012.12.087. Epub 2013 Apr 20.

ReferenceCitation: Bisdas T, Donas KP, Torsello G, Austermann M. Technical assessment of the preloaded fenestrated stent-graft in the management of pararenal aortic aneurysms. J Endovasc Ther. 2013 Aug;20(4):461-8. doi: 10.1583/13-4310.1.

lead_sponsor: IRCCS San Raffaele

location_country:
Germany
Italy
United Kingdom
Denmark
Sweden
United States
Spain
France

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: UMass Memorial Center for Complex Aortic Disease

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Aortic Centre Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Université Paris Saclay

location_facility: Vascular Center Malmö, Skåne University Hospital

location_facility: Department of Surgical Sciences, Vascular Surgery, Uppsala University

intervention_type: Procedure

status_simplified: Completed


acronym: Operetta 2

lead_sponsor: Hoffmann-La Roche

summary: This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with relapsing-remitting multiple sclerosis aged between 10 and < 18 years over a duration of at least 96 weeks.

sponsor_collaborators:
Hoffmann-La Roche
PPD

location_facility: Uniwersytecki Szpital Kliniczny w Poznaniu; Od. Kliniczny Neurologii Dzieci i M?odziezy

location_facility: Centre Hospitalier Ibn Sina CHIS - Hopital des Specialites

location_facility: Hospital Militaire Dinstruction Mohammed V de Rabat

location_facility: University Clinical Center Kragujevac; Clinic of neurology

location_facility: Great Ormond Street Hospital For Children; Neurology

location_facility: Debreceni Egyetem Klinikai Központ; Gyermekklinika

location_facility: Instytut Centrum Zdrowia Matki Polki; Klinika Neurologii

location_facility: Pediatric Multiple Sclerosis and Related Disorders Program at Boston Children's Hospital

location_facility: Centro Hospitalar e Universitário de Coimbra E.P.E.; Hospital Pediátrico

location_facility: Centre Hospitalier Universitaire de Bicêtre

location_facility: University of Colorado Denver Childrens Hospital Rocky Mountain MS Center

location_facility: Hôpital Universitaire des Enfants Reine Fabiola; porte 10, batiment K

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

location_facility: Deenanath Mangeshkar Hospital & Research Centre

location_facility: Medizinische Universität Wien; Univ.Klinik fuer Neurologie

location_facility: Hospital Santo Antonio dos Capuchos; Servico de Neurologia

location_facility: NYU Langone Medical Center; Laura and Isaac Perlmutter Cancer Center

location_facility: IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Neurologii Rozwojowej

location_facility: A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche

location_facility: Instytut Pomnik Centrum Zdrowia Dziecka; Klinika Neurologii i Epileptologii

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: Mother and Child Health Care Institute of Serbia Dr Vukan Cupic

location_facility: Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Neurologia

location_facility: Cleveland Clinic, Mellen Center for Multiple Sclerosis

location_facility: Royal Children's Hospital Melbourne - PIN

location_facility: Universitätsklinikum Münster; Klinik für Kinder- und Jugendmedizin

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia

location_facility: Hippokration General Hospital; First Department of Pediatrics

location_facility: University Clinical Centre of Nis; Clinic of neurology

location_facility: Hopital Pierre Wertheimer - Hopital Neurologique; Service de neurologie

location_facility: Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

location_facility: Centro de Investigacion Clinica Chapultepec S. A. de C. V.

location_facility: Spitalul Clinic de Psihiatrie ?Prof. dr. Alexandru Obregia?; Sectia Clinica Neurologie Pediatrica

location_facility: KZ "Dnipropetrovska oblasna dytiacha klinichna likarnia" DOR

location_facility: Inst. Da Criança- Faculdade de Medicina Usp; Unidade de Pneumologia

location_facility: Fortis Flight Lieutenant Rajan Dhall Hospital

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Multiprofile Hospital For Active Treatment In Neurology And Psychiatry (MHATNP) ''St. Naum"

location_facility: Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

location_facility: A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS)

location_facility: Hospital Universitario de la Princesa; Servicio de Neurologia

location_facility: Universita? G. D'Annunzio; Dipartimento di Neuroscienze, Imaging e Scienze Cliniche

location_facility: Victor Gomoiu Clinical Hospital for Children

location_facility: Ospedale Pediatrico Bambino Gesù; Divisione di Neurologia

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: FAICIC S de R.L. de C.V; FAICIC Clinical Research

location_facility: Baylor College of Medicine/Texas Children's Hospital

location_facility: Royal Hospital for Children and Young People

location_facility: All India Institute Of Medical Sciences (AIIMS)

location_facility: Centro Hospitalar Lisboa Norte, E.P.E. ? Hospital de Santa Maria; Servicos Farmaceuticos

location_facility: Zydus Hospital; Department of Neuro Sciences

location_facility: Universidade de Caxias do Sul - Rio Grande do Sul

location_facility: Clinic for Neurology and Psychiatry for Children and Youth

location_facility: Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan

location_facility: L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME

location_facility: CHRU de Montpellier, Hopital Gui de Chauliac; Service de Neuropediatrie

location_facility: IRCCS Materno Infantile Burlo Garofolo - INCIPIT - PIN

location_facility: Dzieci?cy Szpital Kliniczny im. Józefa Polikarpa Brudzi?skiego; Klinika Neurologii Dzieciecej

location_facility: Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR

location_facility: Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Kinder-und Jugendmedizin_UMG

location_facility: Vestische Kinder- und Jugendklinik Datteln

location_facility: Washington University, Pediatric MS and other Demyelinating Disease Center

location_facility: Hospital Eginition; First Department of Neurology

title: A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis

source: euctr

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

design_allocation: Randomized

location_country:
Germany
Poland
Argentina
Australia
Brazil
Croatia
Canada
Serbia
France
Portugal
Hungary
Denmark
United States
Latvia
Morocco
Ukraine
India
Romania
Belgium
Estonia
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
Greece
Bulgaria

ipd_sharing: Yes


type: Other Identifier

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Two-Arm, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LY3361237 as a Treatment for Adults With At Least Moderately Active Systemic Lupus Erythematosus

summary: The main purpose of this study is to assess the efficacy and safety of LY3361237 in participants with at least moderately active systemic lupus erythematosus (SLE). Study will last up to 34 weeks and may include up to 15 visits.

status: Active, not recruiting

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:
Poland
Argentina
Mexico
United States
Taiwan
Czechia
Puerto Rico
France

location_facility: Chang Gung Memorial Hospital at Kaohsiung

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

location_facility: Instituto de Investigaciones Clinicas Zarate

location_facility: Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan

location_facility: Investigacion Biomedica para el Desarrollo de Fármacos S.A. de C.V.

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

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: Arizona Arthritis & Rheumatology Research - Sun City

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

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

location_facility: Twoja Przychodnia Poznanskie Centrum Medyczne

location_facility: Houston Rheumatology & Arthritis Specialists

location_facility: Atlanta Research Center for Rheumatology

location_facility: Twoja Przychodnia Centrum Medyczne Nowa Sol


acronym: SHIELD

summary: The SHIELD (Screening for High Frequency Malignant Disease) study is a prospective, observational, multi-site basket design trial without randomization. The primary objective of the study is to evaluate the sensitivity and specificity of a blood-based GuardantLUNAR-2 test to detect high frequency cancer in screen-relevant populations.

time_perspective: Prospective

lead_sponsor: Guardant Health, Inc.

location_country:
United States
Spain
France

location_facility: National Institute for Clinical Research

location_facility: Pulmonology Associates Inc.Pulmonology Associates Inc. (Suite 108)

location_facility: Hospital MD Anderson Cancer Center Madrid

location_facility: MedCorps Asthma and Pulmonary Specialists

location_facility: Pulmonary Critical Care & Sleep Associates, P.A.

location_facility: Pulmonary Physicians of South Florida, LLC

location_facility: Long Island Pulmonary and Sleep Medicine Associates

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Tidewater Physicians Multispecialty Group, P.C.

location_facility: Pulmonary, Critical Care & Sleep Disorders Institute of South Florida

location_facility: Best Cancer Care & Hematology - Biopharma Informatic

location_facility: Houston Pulmonary Sleep, Allergy, and Asthma Associates

location_facility: California Medical Research Associates Inc.

location_facility: Pulmonary & Sleep Disorders of New Jersey

location_facility: CHU Amiens Picardie - Centre de Recherche Clinique

intervention_type: Device


title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of treatment combinations in cancer immunotherapy (CIT)-naive participants with resectable Stage III melanoma (Cohort 1) and in participants with Stage IV melanoma (Cohort 2). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and modify the participant population.

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:
Italy
Australia
Netherlands
United States
Spain
France

location_facility: Clinica Universidad de Navarra ; Servicio de Farmacia

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: The Angeles Clinic and Research Institute - W LA Office

location_facility: Hospital Universitario HM Sanchinarro-CIOCC

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

location_facility: Azienda Ospedaliera Universitaria Senese


acronym: PSUMMIT-Jr

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to evaluate the pharmacokinetics (PK), efficacy, safety and immunogenicity of ustekinumab and guselkumab in active juvenile psoriatic arthritis (jPsA).

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

location_facility: Nottingham University Hospitals NHS Trust

title: A Phase 3 Multicenter, Open-label Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Denmark
United States
Spain
Turkey
France


title: Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Symptomatic Generalized Myasthenia Gravis

acronym: NIMBLE

summary:
The primary objective is:

To evaluate the effect of pozelimab + cemdisiran on daily functioning that is impacted by signs and symptoms in patients with symptomatic generalized myasthenia gravis (gMG)

The secondary objectives of the study are:

To evaluate the effect of pozelimab + cemdisiran (ie, combination) and cemdisiran monotherapy on:

Clinician-assessed signs of myasthenia gravis (MG) and muscle strength
Daily functioning that is impacted by signs and symptoms in patients with symptomatic gMG (cemdisiran monotherapy only).
Proportion of patients with improvements in daily function that is impacted by signs and symptoms of MG
Proportion of patients that have improvements in clinician-assessed signs of MG and muscle strength
Health related quality of life
Proportion of patients with minimal MG symptoms
Patient- and clinician-reported signs and symptoms of MG
To evaluate the safety and tolerability of pozelimab + cemdisiran and cemdisiran monotherapy
To assess the concentration of total pozelimab in serum
To assess the concentrations of cemdisiran and its metabolites in plasma
To assess the immunogenicity of pozelimab
To assess the concentration of total C5 in plasma
To assess the immunogenicity of cemdisiran
To study the effect of pozelimab + cemdisiran and cemdisiran monotherapy on complement activation

ipd_sharing_description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Germany
Poland
Australia
Japan
Turkey
Czechia
Canada
Serbia
France
Denmark
United States
India
Belgium
Italy
United Kingdom
Korea, Republic of
Spain
Taiwan
Georgia

location_facility: Deenanath Mangeshkar Hospital and Research Centre

location_facility: Texas Institute for Neurological Disorders - Arlington

location_facility: Perron Institute for Neurological and Translational Science

location_facility: Amrita Institute of Medical Sciences (AIMS) and Research Centre

location_facility: Medical Hospital of Tokyo Medical and Dental University

location_facility: Wayne State University School of Medicine

location_facility: Colorado Springs Neurological Associates

location_facility: Polakulath Narayanan Renai Medicity Multi Specialty Hospital, Kochi

location_facility: Friedrich-Baur-Institute Dep. of Neurology Klinikum Munchen

location_facility: Seth G.S. Medical College & K.E.M. Hospital, Mumbai

location_facility: Prairie Education and Research Cooperative

location_facility: Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

location_facility: Clinical Research Center Spólka z Ograniczona Odpowiedzialnoscia, Medic-R Spólka Komandytowa

location_facility: Bangalore Medical College and Research Institute (BMCRI) - Victoria Hospital

location_facility: Kobe City Medical Center General Hospital

location_facility: Saitama Medical University, Saitama Medical Center

location_facility: Copenhagen Neuromuscular Clinic at Rigshospitalet

location_facility: University Hospital Essen, Dep. of Neurology

location_facility: Israeli-Georgian Medical Research Clinic HEALTHYCORE

location_facility: Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny

location_facility: Okinawa Prefectural Nanbu Medical Center and Children's Medical Center

location_facility: Odense Universitetshospital - Infektionsmedicinsk Afdeling

location_facility: LTD Academician N. Kipshidze Central University Clinic

location_facility: Dayton center for neurological disorders

location_facility: Sheffield Teaching Hospital NHS Foundation Trust

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Karadeniz Technical University Farabi Hospital

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: Centre Hospitalier Universitaire (CHU) de Nice

location_facility: Atrium Health Neurosciences Institute Charlotte, a facility of Carolinas Medical Center

location_facility: All India Institute of Medical Sciences New Delhi

location_facility: Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta

location_facility: University Of Cincinnati Gardner Neuroscience institute

location_facility: Centrum Neurologii Klinicznej, Krakowska Akademia Neurologii

location_facility: Postgraduate Institute of Medical Education & Research

location_facility: Northwest Neurology Ltd. - Clinedge - PPDS

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

location_facility: Weill Cornell Medicine - Peripheral Neuropathy Center

location_facility: University Clinical Center of Serbia - PPDS

location_facility: Centre Hospitalier Regional Universitaire (CHRU) de Nancy

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Université Libre de Bruxelles - Hôpital Erasme

location_facility: Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Nizam's Institute of Medical Sciences (NIMS)


title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Crohn's Disease (CD): AIM-CD

acronym: AIM-CD

summary:
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. This study evaluates how safe and effective ABBV-154 is in participants treated for moderately to severely active CD. Adverse events and change in the disease activity will be assessed.

ABBV-154 is an investigational drug being evaluated for the treatment of CD. In the induction period, there is a 1 in 5 chance that participants will be assigned to placebo. Depending on the dose received in the induction period, there is a 1 in 2 or 1 in 3 chance that participants will be assigned to placebo in the maintenance period. Around 265 participants 18-75 years of age with moderately to severely active CD will be enrolled in the study at approximately 200 sites worldwide.

The study is compromised of a 12-week double-blind, placebo-controlled induction period, followed by either a 12-week double-blind re-induction period for non-responders or a 40-week double-blind placebo-controlled maintenance period for responders. In the maintenance period, responders will be randomized to receive subcutaneous placebo or ABBV-154 in 2 different doses every other week. Participants in the placebo group who are initial responders will receive ABBV-154 in the maintenance period.

There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

status: Terminated

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.

lead_sponsor: AbbVie

location_country:
Germany
Poland
New Zealand
Australia
Japan
Czechia
Canada
France
Portugal
Slovakia
Hungary
United States
Belgium
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Israel

location_facility: Soroka University Medical Center /ID# 233458

location_facility: Gastroenterology Consultants PC - Roswell /ID# 233552

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 249047

location_facility: Gastro Health & Nutrition - Victoria /ID# 240158

location_facility: Iwate Medical University Uchimaru Medical Center /ID# 238953

location_facility: Hyogo Medical University Hospital /ID# 239049

location_facility: Policlinico Agostino Gemelli /ID# 233380

location_facility: Southern California Res. Ctr. /ID# 233512

location_facility: Universitaetsklinikum Erlangen /ID# 233529

location_facility: East View Medical Research, LLC /ID# 240030

location_facility: General Hospital of Athens Ippokratio /ID# 231655

location_facility: Hadassah Medical Center-Hebrew University /ID# 233518

location_facility: Sapporo Medical University Hospital /ID# 239201

location_facility: Agile Clinical Research Trials /ID# 233739

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 232373

location_facility: Hoag Memorial Hosp Presbyterian /ID# 233555

location_facility: Digestive Disease Specialists /ID# 233825

location_facility: CCA Braga - Hospital de Braga /ID# 249049

location_facility: Allegheny Health Network Research Institute /ID# 239334

location_facility: Tokyo Medical University Hospital /ID# 239668

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 234069

location_facility: Hunter Holmes McGuire VA Medical Center /ID# 233759

location_facility: Gastroenterology Associates, P.A. of Greenville /ID# 233544

location_facility: Yamagata University Hospital /ID# 239572

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 238791

location_facility: St. Marianna University Hospital /ID# 239167

location_facility: Center Hospital of the National Center for Global Health and Medicine /ID# 239792

location_facility: Hospital Universitario La Paz /ID# 232300

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 238960

location_facility: Medizinische Hochschule Hannover /ID# 238804

location_facility: The Queen Elizabeth Hospital /ID# 234242

location_facility: Tyler Research Institute, LLC /ID# 233730

location_facility: University of Colorado Hospital /ID# 239361

location_facility: CHRU Nancy - Hopitaux de Brabois /ID# 234224

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 241136

location_facility: Nemocnice Horovice - NH Hospital a.s /ID# 233915

location_facility: Radboud Universitair Medisch Centrum /ID# 241292

location_facility: University Hospital Kyoto Prefectural University of Medicine /ID# 239918

location_facility: Royal Devon University Healthcare NHS Foundation Trust /ID# 234194

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 239965

location_facility: Ustredni Vojenska Nemocnice - Vojenska fakultni nemocnice Praha /ID# 238486

location_facility: National Taiwan University Hospital /ID# 234134

location_facility: University of Utah Hospitals and Clinics /ID# 239264

location_facility: Universitaetsklinikum Freiburg /ID# 233719

location_facility: Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 233387

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 233527

location_facility: Scott Shulman Medicine Professional Corporation /ID# 239567

location_facility: UMHAT Tsaritsa Joanna - ISUL /ID# 234135

location_facility: Concord Repatriation General /ID# 233467

location_facility: Medizinische Universitaet Wien /ID# 234218

location_facility: NHS Greater Glasgow and Clyde /ID# 234186

location_facility: Digestive Disease Consultants - Orange Park /ID# 241015

location_facility: Aichi Medical University Hospital /ID# 238528

location_facility: Gastroenterology Group of Northern NJ - Englewood Division /ID# 241935

location_facility: Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 239554

location_facility: Hospital Santa Creu i Sant Pau /ID# 232301

location_facility: Universitatsklinik Regensburg /ID# 238702

location_facility: The University of Chicago DCAM /ID# 233824

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 234225

location_facility: China Medical University Hospital /ID# 234132

location_facility: Osaka Metropolitan University Hospital /ID# 238638

location_facility: Medizinische Universitaet Innsbruck /ID# 234217

location_facility: Nagoya City University Hospital /ID# 238368

location_facility: Gastroenterology and Internal Medicine Research Institution /ID# 233831

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 233765

location_facility: QE II Health Sciences Centre /ID# 233839

location_facility: Toronto Digestive Disease Asso /ID# 234143

location_facility: Taichung Veterans General Hospital /ID# 234131

location_facility: Hospital Clinico Universitario de Valencia /ID# 234103

location_facility: ASST Rhodense/Presidio Ospedaliero di Rho /ID# 233386

location_facility: Tokyo Women's Medical University Hospital /ID# 239760

location_facility: St George's University Hospitals NHS Foundation Trust /ID# 234193

location_facility: Gastroenterology Group Naples /ID# 233829

location_facility: Universitatsklinikum Mannheim /ID# 233716

location_facility: Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 238653

location_facility: Tsujinaka Hospital Kashiwanoha /ID# 239012

location_facility: Guys and St Thomas NHS Foundation Trust /ID# 234191

location_facility: Hamamatsu University Hospital /ID# 238527

location_facility: Digestive Health Specialists of the Southeast /ID# 239599

location_facility: The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 233700

location_facility: Northshore Gastroentrology Research LLC /ID# 239307

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 231657

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 245604

location_facility: Tokyo Medical And Dental University Hospital /ID# 238950

location_facility: Hiroshima University Hospital /ID# 238947

location_facility: Medical Research Center of CT /ID# 233542

location_facility: New York Gastroenterology Associates /ID# 241967

location_facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 233763

location_facility: The Chaim Sheba Medical Center /ID# 233457

location_facility: Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 232299

location_facility: Southern Star Research Institute, LLC /ID# 240132

location_facility: London Health Sciences Center- University Hospital /ID# 234058

location_facility: Tel Aviv Sourasky Medical Center /ID# 238525

location_facility: WIP Warsaw IBD Point Profesor Kierkus /ID# 233533

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 233382

location_facility: Toronto Immune and Digestive Health Institute Inc /ID# 234142

location_facility: Atlantic Medical Research Group /ID# 233506

location_facility: Acibadem City Clinic University Hospital EOOD /ID# 240003

location_facility: Fukushima Medical University Hospital /ID# 239314

location_facility: General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 231659

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 231660

location_facility: The Edith Wolfson Medical Center /ID# 234042

location_facility: Kanazawa University Hospital /ID# 239670

location_facility: Wellington Regional Hospital /ID# 238326

location_facility: Louisana Research Center, LLC /ID# 245370

status_simplified: Unknown


acronym: cosMOG

lead_sponsor: UCB Biopharma SRL

summary: The purpose of the study is to evalute the efficacy, safety and tolerability of rozanolixizumab for treatment of adult participants with myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOG-AD).

ReferenceCitation: Mader S, Kumpfel T, Meinl E. Pathomechanisms in demyelination and astrocytopathy: autoantibodies to AQP4, MOG, GFAP, GRP78 and beyond. Curr Opin Neurol. 2022 Jun 1;35(3):427-435. doi: 10.1097/WCO.0000000000001052.

oa_host_type: closed

publisher_dissemination: Wolters Kluwer Health

title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3, Pivotal Study With an Open-Label Extension Period to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-Associated Disease (MOG-AD)

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:
Germany
Italy
Portugal
United Kingdom
Australia
Brazil
Japan
Mexico
Belgium
Sweden
United States
Korea, Republic of
Spain
Switzerland
Turkey
Czechia
Ukraine
France


title: A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma

summary: The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

location_country:
United Kingdom
Australia
Netherlands
Belgium
United States
France

location_facility: Institut Universitaire du cancer de Toulouse-Oncopole


title: A Phase III, Open Label, Randomised, 3-Arm, Multi-Centre Study of Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (SAMETA)

acronym: SAMETA

summary: A clinical trial to compare the effectiveness of savolitinib plus durvalumab versus sunitinib in MET-driven (hepatocyte growth factor receptor), unresectable and locally advanced or metastatic PRCC (Papillary Renal Cell Carcinoma)

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:
Germany
Poland
Argentina
Australia
Brazil
Turkey
Chile
Czechia
Canada
France
Slovakia
Hong Kong
United States
Ukraine
India
Romania
China
Italy
United Kingdom
Singapore
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


acronym: POSTERITY

summary: This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to <12 with LN.

sponsor_collaborators:
Hoffmann-La Roche
Genentech, Inc.

location_facility: Hôpital Robert Debré; Nephrologie pediatrique

location_facility: Universidade Federal de Sao Paulo - UNIFES

location_facility: Children's Hospital Colorado, Anchutz Medical Campus

location_facility: Great Ormond Street Hospital for Children

location_facility: Szpital Specjalistyczny dla Dzieci i Doroslych; Oddzial Kliniczny Pediatrii i Nefrologii

location_facility: Red Cross War Memorial Children?s Hospital; Nephrology Unit

location_facility: Hospital Ramon y Cajal ; Servicio de Reumatologia

location_facility: Ospedale Pediatrico Bambino Gesu; U.O. Di Nefrologia E Dialisi

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadci?nienia Dzieci i Mlodziezy

location_facility: Cohen Children's Medical Center of New York; Pediatrics

location_facility: Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica

location_facility: Saint-Petersburg State; Pediatrics Medical Academy

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria

location_facility: Indiana University Health University Hospital

location_facility: IRCCS G. Gaslini; U.O. Nefrologia, Dialisi e Trapianto

location_facility: Hospital Sant Joan De Deu; Servicio de Reumatologia Pediatrica

location_facility: Hospital de La Paz; Unidad de Reumatologia Pediatrica

location_facility: Ser Servicos Especializados Em Reumatologia

location_facility: CHU de Toulouse - Hôpital des Enfants; Nephro - Rhumato - Medecine Interne - Hypertension

location_facility: CREA Hospital Mexico Americano; Clinica Pediatrica de Reumatologia y Enfermedades Autoinmunes

title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients With Active Class III or IV Lupus Nephritis, Including an Evaluation of Open Label Safety and PK in a Cohort of Pediatric Patients (Aged 5 to < 12)

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:
Italy
Poland
United Kingdom
Brazil
Mexico
United States
Spain
South Africa
Peru
Canada
Russian Federation
France


title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations.

lead_sponsor: Genentech, Inc.

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Chile
Czechia
Canada
France
Hong Kong
Denmark
United States
Romania
Belgium
Peru
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Bulgaria
Israel

location_facility: Centro Integral de Medicina Respiratoria (CIMER)

location_facility: Spitalul Clinic de Pneumoftiziologie Constanta

location_facility: Zentrum fuer Pneumologie, Onkologie und Schlafmedizin am Diako

location_facility: Pulmonary Specialists of the Palm Beaches

location_facility: University of Cape Town Lung Institute; Lung Clinical Research

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Gemeinscharftspraxis Dres Jung - Deggingen

location_facility: Instituto De Enfermedades Respiratorias E Investigacion Medica

location_facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

location_facility: Clinica Providencia (Inverconsult Sociedad Anonima)

location_facility: Centro de Investigaciones Medicas Mar Del Plata

location_facility: Neomed Out-Patient Treatment and Diagnosis Medical Center SRL

location_facility: Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility

location_facility: Cincinnati Veterans Affairs Medical Center - NAVREF - PPDS

location_facility: Piedmont Research Partners LLC - Clinedge - PPDS

location_facility: Catholic Univ. of Incheon St.Mary's Hospital

location_facility: Clinical Site Partners - Leesburg Suite 101 - HyperCore - PPDS

location_facility: Horizon Clinical Research Group: Houston Pulmonary Sleep & Allergy Associates -Clinedge ? PPDS

location_facility: Sf. Ioan cel Nou Emergency County Hospital

location_facility: Centro de Investigaciones Clínicas Belgrano

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Sherman Clinical Research - ClinEdge - PPDS

location_facility: Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD

location_facility: Medical Center Leo Clinic EOOD, branch Lovech

location_facility: University of Florida College of Medicine Jacksonville

location_facility: University of Texas Health Sciences Center in San Antonio

location_facility: Clinique de pneumologie et du sommeil de Lanaudiere

location_facility: Florida Institute for Clinical Research, LLC

location_facility: South Texas Medical Research Institute, Inc., dba TTS Research ? ClinEdge ? PPDS

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Centro de Investigaciones Medicas Respiratorias

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

location_facility: Columbus Regional Research Institute at Talbotton - IACT - HyperCore - PPDS

location_facility: Instituto de Investigaciones Clinicas-Mar del Plata

location_facility: EMED Centrum Uslug Medycznych Ewa Smialek

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Clinical Site Partners - Winter Park - HyperCore - PPDS

location_facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Dr.Nikola Penchev-Paza

location_facility: SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS

location_facility: Sierra Clinical Research - ClinEdge - PPDS

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Medizinische Universitat Wien Medical University of Vienna

location_facility: PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna

location_facility: Investigaciones en Patologias Respiratorias

location_facility: Centrum Medyczne Bydgoszcz- PRATIA - PPDS

location_facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Velocity Clinical Research Spartanburg PPDS

location_facility: VA Loma Linda Healthcare System - NAVREF - PPDS

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska lek.

location_facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

location_facility: Twoja Przychodnia Centrum Medyczne Nowa Sol

location_facility: Instituto Medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion Medica

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.

location_facility: Medical Center New rehabilitation center EOOD

location_facility: St. Francis Sleep; Allergy & Lung Institute

location_facility: St. Joseph's Healthcare Hamilton- Charlton Campus

location_facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa

location_facility: Feinberg School of Medicine Northwestern University

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.

location_facility: Leon Daniello Pneumophthisiology Clinical Hospital

location_facility: University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD

location_facility: Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik; Krzysztof Cudzik

location_facility: Centro de Investigacion y Atencion Integral Durango CIAID

location_facility: Unidad de Investigacion Clinica En Medicina (Udicem) S.C.

location_facility: Private Practice Dr Jean Benoit Martinot

location_facility: CARE - Centro de Alergia y Enfermedades Respiratorias

location_facility: Zentrum fuer ambulante pneumologische Forschung Marburg GbR


title: A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

acronym: BRUIN CLL-313

summary: The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.

lead_sponsor: Loxo Oncology, Inc.

sponsor_collaborators:
Loxo Oncology, Inc.
Eli Lilly and Company

location_country:
Ireland
Poland
New Zealand
Australia
Brazil
Japan
Czechia
France
Portugal
Hungary
United States
Romania
China
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation

location_facility: Severance Hospital, Yonsei University Health System

location_facility: A.O.U. Citta' della Salute e della Scienza di Torino

location_facility: Cancer Center of Guangzhou Medical University

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)

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

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum

location_facility: Spitalul Clinic Judetean De Urgenta Oradea

location_facility: Spitalul Clinic Municipal Filantropia Craiova

location_facility: Institute of hematology&blood disease hospital

location_facility: Hospital of University of Occupational and Environmental Health

location_facility: Institutul Clinic Fundeni - Centrul de Hematologie si Transplant Medular

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Academician I.P. Pavlov First St-Petersburg State Medical University

location_facility: Shengjing Hospital of China Medical University

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures

location_facility: North Shore Hospital, Haematology Research

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C

location_facility: Oncology-Hematology Associates of West Broward

location_facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela w BydgoszczyKlinika Hematologii

location_facility: Azienda sanitaria integrata università di Trieste

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Centro Integrado de Oncologia de Curitiba

location_facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

location_facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

location_facility: The First People's Hospital of Hangzhou Linping District

location_facility: Our Lady of the Snow St. Mary's Hospital

location_facility: Centro Gaucho Integrado - Mae de Deus Center

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Hospital Universitario Central de Asturias

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

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Chu Nimes/Institut De Cancerologie Du Gard

location_facility: Dokkyo Medical University - Koshigaya Hospital

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Cuire - Państwowy Instytut Badawczy

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

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

location_facility: West China Hospital of Sichuan University

location_facility: Klinika Hematoonkologii i Transplantacji Szpiku SPSK1 Lublin

location_facility: Instituto do Câncer - Hospital São Vicente de Paulo

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"


title: A Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease

acronym: APOLLO-CD

summary:
The purpose of this study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active Crohn's Disease.

After the completion of the 12-week induction period, all participants have the option to continue in the open-label extension for another 38 weeks.

lead_sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

location_country:
Poland
Australia
Belgium
United States
Czechia
Canada
Georgia
France

location_facility:
Prometheus Biosciences Selected Site
Prometheus Biosciences Selected Center


title: A Phase 3b/4, Double-masked, Randomized, International, Parallel-assignment, Multicenter Trial in Patients With Thyroid Eye Disease to Evaluate the Safety and Tolerability of Different Dosing Durations of Teprotumumab

summary: This is a double-masked, randomized, parallel-assignment, multicenter trial examining the safety and tolerability of teprotumumab in the treatment of Thyroid Eye Disease (TED) in adult participants. This international, Phase 3b/4 trial is being conducted to fulfill an FDA post-marketing requirement for a descriptive trial to evaluate the safety, efficacy and need for re-treatment of 3 different teprotumumab treatment durations for TED. In addition, serum samples from participants with a Baseline Clinical Activity Score (CAS) ≥3 will be evaluated for biomarkers of disease.

ipd_sharing: Undecided

lead_sponsor: Horizon Therapeutics USA, Inc.

location_country:
Germany
Italy
United Kingdom
United States
Spain
France

location_facility: UCLA Health, Beverley Hills Primary & Specialty care

location_facility: Centre Hospitalier National D'ophtalmologie Des Quinze Vingts

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi

location_facility: ASST dei Sette Laghi - Ospedale Di Circolo E Fondazione Macchi

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Royal Victoria Infirmary, Newcastle Eye Centre


title: CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting

acronym: MANTRA

summary:
MANTRA is a prospective, multiple-arm, multi-center, global, post-market clinical follow-up study. The main objective is to monitor ongoing safety and performance of the CORCYM devices and accessories used for aortic, mitral and tricuspid valvular diseases in a real-world setting.

Corcym S.r.l., is a medical device manufacturer with a broad product portfolio for cardiac surgeons, offering solutions for the treatment of aortic, mitral and tricuspid valve disease.

The MANTRA Master Plan (Master Protocol) is intended as an overarching Umbrella Protocol that allows multiple sub-studies to be added, as needed. The Umbrella Master Protocol concept offers an excellent solution to provide post-marketing clinical follow-up information on the entire cardiac surgery heart valve portfolio of the sponsor in a common database, including corelab assessment of hemodynamic and structural performance, annular motion and Dynamics for one of the products.

Currently, three sub-studies are planned:

MANTRA - Aortic Sub-Study
MANTRA - Mitral/Tricuspid Sub-Study (Excluding Memo 4D)
MANTRA - Memo 4D Sub-Study

lead_sponsor: Corcym S.r.l

location_country:
Germany
Italy
Portugal
United Kingdom
Netherlands
Austria
Belgium
Switzerland
United States
Korea, Republic of
Canada
Serbia
France

location_facility: University of Calgary (Foothills Hospital)

location_facility: A.O.U. Citta della Salute e della Scienza di Torino - Ospedale Molinette

location_facility: Pusan National University Yangsan Hospital

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: CHU Toulouse_Rangueil University Hospital

location_facility: Az. Ospedaliero-Universitaria "Ospedali Riuniti" di Trieste

location_facility: CHU Clermont-Ferrand_Hopital Gabriel Montpied

location_facility: Azienda ospedaliera dei Colli - Ospedale Monaldi


acronym: EMERALD

lead_sponsor: Swedish Orphan Biovitrum

summary: The purpose of this study is to assess the safety, tolerability and efficacy of emapalumab in children and adults with macrophage activation syndrome (sHLH/MAS) in Still's disease (including systemic juvenile idiopathic arthritis and adult onset Still's disease) or with sHLH/MAS in systemic lupus erythematous, resenting an inadequate response to high dose glucocorticoid treatment.

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: Tokyo Medical and Dental University Hospital

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

location_facility: Centre Hospitalier Universitaire Sainte-Justine

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Ortopedyczno - Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: Nationwide Children's Hospital, Abigail Wexner Research Institute

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Centre Hospitalier de l'Université de Montréal

location_facility: Rheumatology Clinic at University of Washington Medical Center - Roosevelt

location_facility: IRCCS - Materno-Infantile Burlo Garofolo

location_facility: Szpital Specjalistyczny im. J. Dietla w Krakowie

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: University of Minnesota Masonic Children's Hospital

location_facility: Karolinska Universitetssjukhuset Solna (Ped. Rheum.)

title: A Two-cohort, Open-label, Single Arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, PK and PD, of Emapalumab in Children and Adults With MAS in Still's Disease or With MAS in Systemic Lupus Erythematous

location_country:
Germany
Italy
Poland
United Kingdom
Japan
Sweden
Netherlands
Belgium
United States
China
Spain
Czechia
Canada
France


acronym: Ravulizumab versus Placebo in Adult Participants with Dermatomyositis.

lead_sponsor: Alexion Pharmaceuticals, Inc.

summary: This is a Phase 2/3, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in adult participants with dermatomyositis (DM).

title: A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Dermatomyositis

ipd_sharing_description: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

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


lead_sponsor: Amgen

summary:
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC).

Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Participants who complete the 12-week induction period will have the option to enter an exploratory long-term treatment period for up to 40 weeks (total of up to 52 weeks of treatment) if, in the opinion of the investigator, they may benefit from continued treatment. During the long-term period, participants randomized to efavaleukin alfa will remain on the same efavaleukin alfa blinded dose; participants randomized to placebo who achieved clinical response at week 12 will remain on placebo; and placebo non-responders (ie, participants randomized to placebo who did not achieve clinical response at week 12) will receive efavaleukin alfa in a blinded manner during continued treatment. All participants will complete a safety follow-up visit 6 weeks after their last dose of investigational product.

location_facility: Birmingham Digestive Health Research, LLC

location_facility: Oleg Tyszkiwski Centrum Gastrologiczne Gorczyn Oleg Tyszkiwski

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Hastanesi

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Columbus Regional Research Institute, LLC

location_facility: Gaziantep Universitesi Tip Fakultesi Hastanesi

location_facility: Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

location_facility: General University Hospital of Patras Panagia i Voithia

location_facility: EuroMediCare Przychodnia Specjalistyczna we Wroclawiu

location_facility: Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz

location_facility: Acibadem City Clinic University Multiprofile Hospital for Active Treatment Mladost EOOD

location_facility: Aoyama Clinic GI Endoscopy and IBD Center

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: Diagnostic-Consultative Center Convex EOOD

location_facility: Santa Maria Gastroenterology Medical Group

location_facility: Digestive Health Research of North Texas LLC

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Digestive Health Specialists of the Southeast

location_facility: London Health Sciences Centre, University Hospital

location_facility: Clinica de Investigacion en Reumatologia y Obesidad SC

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Nemocnice Milosrdnych sester sv Karla Boromejskeho v Praze

location_facility: Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: The Catholic University of Korea Seoul St Marys Hospital

location_facility: New York University Langone Medical Center

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada SC

location_facility: Kocaeli Universitesi Tip Fakultesi Hastanesi

location_facility: Centro de Investigaciones Medicas Mar del Plata

location_facility: CRI Centro Regiomontano de Investigacion SC

location_facility: Hospital Privado Centro Medico de Cordoba SA

location_facility: Mersin Universitesi Tip Fakultesi Hastanesi

location_facility: Komarom-Esztergom Varmegyei Szent Borbala Korhaz

location_facility: Bekes Varmegyei Kozponti Korhaz Dr Rethy Pal Tagkorhaz

location_facility: Centre Hospitalier Universitaire Amiens Picardie

location_facility: Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi

location_facility: Investigacion Biomedica para el Desarrollo de Farmacos SA de CV

location_facility: Southern Therapy and Advanced Research LLC - Jackson

location_facility: Affiliates in Gastroenterology Digestive Disease Research

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Digestive Research of Central Texas, LLC

location_facility: Nemocnice Pardubickeho kraje as, Pardubicka nemocnice

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Pauls Stradins Clinical University Hospital

location_facility: BodyClinic spolka z ograniczona odpowiedzialnoscia

location_facility: Arizona Arthritis and Rheumatology Research, PLLC

location_facility: Uludag Universitesi Tip Fakultesi Hastanesi

location_facility: Azienda Ospedaliera Universitaria Renato Dulbecco

location_facility: Medical Corporation ENEXT Ikebukuro West Gate Hospital

location_facility: Hospital San Jose Tec Salud Fundacion Santos y de la Garza Evia IBP

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Hunter Holmes McGuire Veterans Medical Center

location_facility: Gastrointestinal Associates Research, llc

location_facility: Harvard Medical School - Brigham and Womens Hospital

location_facility: Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord

location_facility: Centre Hospitalier Universitaire Archet 2

location_facility: University General Hospital of Alexandroupolis

location_facility: Second Multiprofile Hospital for Active Treatment - Sofia EAD

location_facility: Fakultna Nemocnica s poliklinikou FD Roosevelta Banska Bystrica

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

title: A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

location_country:
Finland
Germany
Poland
Argentina
Japan
Turkey
Czechia
Canada
France
Slovakia
Hungary
Denmark
Switzerland
United States
Latvia
Romania
Belgium
Italy
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria


lead_sponsor: Novartis Pharmaceuticals

summary: This is a 52-week, Phase 3 multi-center, randomized, double-blind and placebo-controlled study to assess the safety and clinical efficacy of two dosing regimens of ligelizumab (240 mg and 120 mg) subcutaneous injection every 4 weeks (SCq4w) in participants with a medically confirmed diagnosis of IgE-mediated peanut allergy.

title: A 52 Week, Multi-center, Randomized, Double-blind Placebo-controlled Study to Assess the Clinical Efficacy and Safety of Ligelizumab (QGE031) in Decreasing the Sensitivity to Peanuts in Patients With Peanut Allergy

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:
Germany
Italy
Denmark
Australia
Japan
Netherlands
United States
Spain
Canada
France


title: A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

summary: The study is designed to compare the efficacy of asciminib 80 mg QD versus Investigator selected TKI for the treatment of newly diagnosed, previously untreated patients with Ph+ CML-CP. The Investigator selected TKI will be one of the following treatment options for first-line treatment of CML-CP - imatinib 400 mg QD or nilotinib 300 mg BID or dasatinib 100 mg QD or bosutinib 400 mg QD.

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 are 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:
Finland
Germany
Australia
Japan
Czechia
Canada
France
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
India
Belgium
China
Malaysia
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Bulgaria
Israel

location_facility: Uni of Massachusetts Medical Center Dept of Oncology

location_facility: Chattanooga Oncology and Hematology Associates PC Tennessee Oncology Chattanooga

location_facility: Florida Cancer Specialists Dept of Oncology (2)

location_facility: Wake Forest University Baptist Medical Center Comprehensive Cancer Ctr


acronym: COMMUTE-p

summary: This study aims to evaluate the efficacy and safety of crovalimab in pediatric participants with aHUS.

sponsor_collaborators:
Hoffmann-La Roche
Chugai Pharmaceutical

location_facility: Hôpital Robert Debré; Nephrologie pediatrique

location_facility: Instytut ?Centrum Zdrowia Matki Polki; Klinika Pediatrii i Immunologii i Nefrologii

location_facility: Beijing Children's Hospital, Capital Medical University

location_facility: Inst. Da Criança- Faculdade de Medicina Usp; Unidade de Pneumologia

location_facility: Hôpital Arnaud de Villeneuve; Néphrologie pédiatrique

location_facility: Red Cross War Memorial Children's Hospital; Pediatric Nephrology

location_facility: Szpital Kliniczny nr 1 im. prof. Szyszko; Oddz. Nefrologii Dzieciecej z Pododdzia?em Dializoterapii

location_facility: UT Health Science Center; SouthTexas Pediatric Blood and Cancer Ctr

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadci?nienia Dzieci i Mlodziezy

location_facility: Rambam medical Center; Pediatric Nephrology

location_facility: The children's hospital , Zhejiang university school of medicine

location_facility: Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

location_facility: Hospital de Especialidades Puerta de Hierro S.A de C.V.

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; Nefrologia Pediatrica

location_facility: University of Nebraska; Pediatric Nephrology

location_facility: Aichi Children?s Health and Medical Center

location_facility: Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego

location_facility: Santa Casa de Belo Horizonte; Centro de Hemodiálise

location_facility: University Of Utah Hosp & Clin; Investigational Pharmacy

location_facility: UPECLIN Hospital das Clinicas da Faculdade de Medicina de Botucatu

location_facility: CHU de Toulouse - Hôpital des Enfants; Nephro - Rhumato - Medecine Interne - Hypertension

location_facility: Szegedi Tudományagyetem; Gyermekgyógyászati Klinika

location_facility: Okinawa Prefectural Nanbu Medical Center & Children's Medical Center

location_facility: Cincinnati Children's Hospital Medical Center; Investigational Drug Services

title: A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Pediatric Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

location_country:
Italy
Poland
Hungary
Israel
Japan
Brazil
Mexico
Belgium
United States
China
Spain
South Africa
Canada
France


title: Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

summary: The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG).

location_country:
Germany
Italy
Poland
Denmark
Australia
Japan
Sweden
Mexico
Belgium
United States
China
Korea, Republic of
Spain
Taiwan
Czechia
Canada
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Tianjin Medical University General Hospital

location_facility: Universitatsklinikum Schleswig Holstein Campus Lubeck

location_facility: Central South University Xiangya Hospital The First Affiliated Hospital of Hunan Medical College

location_facility: Qianfoshan hospital of Shandong Province

location_facility: Neuromuscular Research Center and Clinic

location_facility: The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'

location_facility: Fujian Medical University Union Hospital

location_facility: University of Colorado - Anschutz Medical Campus

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: FM Clinical Research, LLC South Florida Neurology Associates, P. A.

location_facility: DKD HELIOS Klinik Wiesbaden, Fachbereich Neurologie

location_facility: Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli

location_facility: Beijing Tiantan Hospital, Capital Medical University

location_facility: IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: The First Bethune Hospital of Jilin University

location_facility: Washington University School of Medicine

location_facility: Xuanwu Hospital ,Capital Medical University

location_facility: Centrum Neurologii Klinicznej, Krakowska Akademia Neurologii

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

location_facility: University of Florida Health Jacksonville

location_facility: Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza

location_facility: National Hospital Organization Sendai Medical Center

location_facility: West China Hospital of Sichuan University

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital

location_facility: Kyungpook National University Chilgok Hospital


title: A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma

acronym: ChonDRAgon

summary: Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.

lead_sponsor: Inhibrx, Inc.

location_country:
Ireland
Germany
Italy
United Kingdom
Australia
Netherlands
United States
Spain
France

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

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: University of California, San Francisco (UCSF)

location_facility: IRCCS Istituto Ortopedico Rizzoli di Bologna

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Oklahoma State University (OSU) - Stephenson Cancer Center

location_facility: Oregon Health & Science University (OHSU) Knight Cancer Institute

location_facility: Washington University School of Medicine - St. Louis

location_facility: University College London Hospital (UCL)

location_facility: Policlinico Universitario Campus Biomedico

location_facility: Hospital de la Santa Creu i Sant Pau Barcelona

location_facility: Saint Vincent's University Hospital part of Irish Sarcoma Group


title: A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

summary:
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse events will be assessed.

Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of Teliso-V or Docetax at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 250 sites worldwide.

Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
France
Portugal
Slovakia
Denmark
United States
Romania
Belgium
China
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Israel

location_facility: Centro de Investigacion Clínica Chapultepec SA de CV /ID# 231928

location_facility: Bagcilar Medipol Mega Universite Hastanesi /ID# 234211

location_facility: Hiroshima University Hospital /ID# 241882

location_facility: The First Affiliated Hospital of Xiamen University /ID# 242381

location_facility: University of Miyazaki Hospital /ID# 242161

location_facility: Sjællands Universitetshospital, Roskilde /ID# 241842

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University /ID# 232023

location_facility: Alliance for Multispecialty Research (AMR) - Kansas City /ID# 247567

location_facility: Fukushima Medical University Hospital /ID# 249691

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 241930

location_facility: S.C. Sigmedical Services SRL /ID# 239108

location_facility: Thoraxklinik Heidelberg gGmbH /ID# 239656

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 231904

location_facility: Yamagata University Hospital /ID# 240815

location_facility: Nottingham University Hospitals NHS Trust /ID# 254707

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 230824

location_facility: Hirosaki University Hospital /ID# 242377

location_facility: Fundacion Arturo Lopez Perez /ID# 231151

location_facility: Hospital Universitario de Jaen /ID# 240588

location_facility: Kitasato University Hospital /ID# 239958

location_facility: National Cancer Center Hospital East /ID# 233775

location_facility: National Hospital Organization Mie Chuo Medical Center /ID# 246659

location_facility: SMG-SNU Boramae Medical Center /ID# 233710

location_facility: Hospital Clinico Universitario de Valencia /ID# 240378

location_facility: Juntendo University Hospital /ID# 239932

location_facility: Instituto D'or de Pesquisa e Ensino /ID# 233245

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 244953

location_facility: Taipei Medical University Hospital /ID# 238380

location_facility: Instituto de Ensino e Pesquisas Sao Lucas /ID# 247417

location_facility: Nemocnice AGEL Novy Jicin, a.s. /ID# 232427

location_facility: Osaka Habikino Medical Center /ID# 239989

location_facility: CHA University Bundang Medical Center /ID# 233318

location_facility: Medizinische Universitaet Wien /ID# 230615

location_facility: Universitatsklinikum Mannheim /ID# 238331

location_facility: Fujieda Municipal General Hospital /ID# 255155

location_facility: Cancer Hospital of Shantou University Medical College /ID# 242182

location_facility: Karolinska University Hospital /ID# 229853

location_facility: National Hospital Organization Tokyo Medical Center /ID# 246581

location_facility: Taizhou Hospital, Zhejiang Province /ID# 232021

location_facility: Dept Medical Oncology, University of Pretoria and Steve Biko Academic Hospital /ID# 230883

location_facility: Fujian Provincial Cancer Hospital /ID# 243134

location_facility: Azienda Socio Sanitaria Territoriale di Cremona /ID# 238698

location_facility: National Hospital Organization Mito Medical Center /ID# 241709

location_facility: Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228

location_facility: Goshen Center for Cancer Care /ID# 257734

location_facility: Inonu Universitesi Turgut Ozal /ID# 234038

location_facility: Kanagawa Cardiovascular and Respiratory Center /ID# 239052

location_facility: Yokohama City University Medical Center /ID# 246554

location_facility: Yamaguchi - Ube Medical Center /ID# 258779

location_facility: Hospital Universitario Dexeus - Grupo Quironsalud /ID# 255105

location_facility: Centro de Investigaciones Clinicas Clinica Viedma S.A. /ID# 232339

location_facility: Ensino e Terapia de Inovacao Clínica AMO - Etica /ID# 231604

location_facility: Trinity Health St. Joseph Mercy Ann Arbor /ID# 232190

location_facility: The First affiliated Hospital of Nanyang Medical College /ID# 244652

location_facility: Hopital Arnaud de Villeneuve /ID# 239404

location_facility: Azienda Ospedaliera di Perugia /ID# 238473

location_facility: Hospital Nuestra Senora de Sonsoles /ID# 255102

location_facility: Hospital Britanico de Buenos Aires /ID# 231495

location_facility: Renown Medical Group - Oncology/Hematology /ID# 247942

location_facility: National Taiwan University Hospital - Hsinchu branch /ID# 238393

location_facility: Tongji Hospital Tongji Medical College of HUST /ID# 239575

location_facility: Complex Cancer Center Plovdiv /ID# 234106

location_facility: The Oncology Institute of Hope and Innovation - DTLA /ID# 239774

location_facility: National Hospital Organization Kyushu Medical Center /ID# 238533

location_facility: Ege University Medical Faculty /ID# 234039

location_facility: Osaka Metropolitan University Hospital /ID# 238895

location_facility: The Edith Wolfson Medical Center /ID# 233781

location_facility: Hospital Universitario 12 de Octubre /ID# 240176

location_facility: Affiliated Hospital Of Guangdong Medical University /ID# 233317

location_facility: Kumamoto University Hospital /ID# 241039

location_facility: Kobe Minimally Invasive Cancer Center /ID# 254131

location_facility: Maastricht Universitair Medisch Centrum /ID# 233932

location_facility: First Health of the Carolinas /ID# 241279

location_facility: Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 240826

location_facility: Azienda Ospedaliera San Giovanni Addolorata /ID# 238618

location_facility: Hokkaido University Hospital /ID# 241289

location_facility: The First Affiliated Hospital of Nanchang University /ID# 231934

location_facility: The Second Affiliated Hospital of Nanchang University /ID# 231935

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 230084

location_facility: Gyeongsang National University Hospital /ID# 234244

location_facility: Tianjin Medical University Cancer Institute and Hospital /ID# 233176

location_facility: Edward-Elmhurst Cancer Center /ID# 238552

location_facility: I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 238696

location_facility: Chung Shan Medical University Hospital /ID# 238444

location_facility: Sociedad Prosalud Montes y Orlandi /ID# 231154

location_facility: Beijing Chest Hospital, Capital Medical University /ID# 232202

location_facility: Guizhou Provincial People's Hospital /ID# 243614

location_facility: Sandton Oncology Medical Group PTY Ltd /ID# 230843

location_facility: Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 241572

location_facility: Instytut Centrum Zdrowia Matki Polki /ID# 239024

location_facility: Gunma Prefectural Cancer Center /ID# 233723

location_facility: Clinical Research & Oncology Oaxaca /ID# 231883

location_facility: Wakayama Medical University Hospital /ID# 234004

location_facility: Affiliated Hospital of Hebei University /ID# 239586

location_facility: Casa de Saúde Santa Marcelina /ID# 231605

location_facility: The First Hospital of China Medical University /ID# 231924

location_facility: UOMi Cancer Center - Clinica Tres Torres /ID# 240584

location_facility: Hospital Universitario Fundacion Alcorcon /ID# 255100

location_facility: Hospital La Louviere Site Jolimont - Helora /ID# 246771

location_facility: National Cancer Center Hospital /ID# 251134

location_facility: Klinikum Wels-Grieskirchen GmbH /ID# 249000

location_facility: Kaiser Permanente Moanalua Medical Center /ID# 238363

location_facility: Ibaraki Prefectural Central Hospital /ID# 246145

location_facility: Tianjin Medical University General Hospital /ID# 231839

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 231509

location_facility: Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie /ID# 239025

location_facility: Henan Provincial People's Hospital /ID# 242187

location_facility: SC RTC Radiology Therapeutic Center SRL /ID# 240744

location_facility: Complex Oncology Center - Burgas /ID# 240532

location_facility: Kansai Medical University Hospital /ID# 233476

location_facility: West China Hospital, Sichuan University /ID# 233703

location_facility: Iwate Medical University Hospital /ID# 239027

location_facility: The Second Hospital of Dalian Medical University /ID# 239755

location_facility: Oncocenter - Oncologie Clinica Srl /Id# 239103

location_facility: CHU UCL Namur - Sainte Elisabeth /ID# 246769

location_facility: Universitaetsklinikum Giessen /ID# 252973

location_facility: Sahlgrenska University Hospital /ID# 229943

location_facility: University College London Hospitals NHS Foundation Trust /ID# 249407

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 233247

location_facility: The First Affiliated Hospital of Guangzhou Medical University /ID# 238591

location_facility: National Taiwan University Hospital /ID# 238378

location_facility: Clinica Universidad Catolica del Maule /ID# 231294

location_facility: Peking Union Medical College Hospital /ID# 233175

location_facility: Hospital of the University of Occupational and Environmental Health, Japan /ID# 241191

location_facility: Universitaetsklinikum Hamburg-Eppendorf /ID# 239658

location_facility: The Affiliated Hospital of Inner Mongolia Medical University /ID# 242179

location_facility: Universitair Ziekenhuis Antwerpen /ID# 239971

location_facility: Uludag University Medical Faculty /ID# 234205

location_facility: San Juan Oncology Associates /ID# 244387

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 232032

location_facility: Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 234209

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 240967

location_facility: Harbin Medical University Cancer Hospital /Id# 231941

location_facility: Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 232467

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre /ID# 233249


title: A Multi-center, Open-label Study to Determine the Dose and Safety of Oral Asciminib in Pediatric Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia in Chronic Phase (Ph+ CML-CP), Previously Treated With One or More Tyrosine Kinase Inhibitors

summary: The aim of this study is to support development of asciminib in the pediatric population (1 to <18 years) previously treated with one or more TKIs. Full extrapolation of the efficacy of asciminib from adult to pediatric patients will be conducted. Full extrapolation is based on the concept that CML in the pediatric population has the same pathogenesis, similar clinical characteristics and progression pattern as in adults.

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

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

location_country:
Germany
Italy
Poland
Hungary
Japan
Netherlands
United States
China
Korea, Republic of
Thailand
Greece
Turkey
Russian Federation
France

location_facility: Dana Farber Cancer Institute Dept.of DFCI

location_facility: Columbia University Medical Center- New York Presbyterian Herbert Irving Cancer Center

location_facility: University of Utah Primary Childrens Hospital


title: A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Best Standard of Care in Patients With Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor-Positive (SSTR+), Neuroendocrine Tumours of GastroEnteric or Pancreatic Origin

acronym: COMPOSE

summary: The purpose of the study is to evaluate the efficacy, safety & patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.

lead_sponsor: ITM Solucin GmbH

location_country:
Germany
Italy
India
United Kingdom
Australia
Sweden
Netherlands
United States
Spain
France

location_facility: Washington University Alvin J. Siteman Cancer Center

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University Hospital Bonn, Department of Nuclear Medicine

location_facility: University Hospital "Federico II", Department of Molecular and Clinical Endocrinology and Oncology

location_facility: Uppsala University Hospital, Department of Oncology

location_facility: University Hospital Vall d'Hebron, Department of Medical Oncology

location_facility: University Hospital Erlangen, Department of Internal Medicine I - Endocrinology

location_facility: University and Polytechnic Hospital La Fe, Endocrinology

location_facility: Tata Memorial Hospital, Nuclear Medicine & Molecular Imaging

location_facility: Duke University School of Medicine, Duke Cancer Institute

location_facility: European Institute of Oncology (IEO), IRCCS

location_facility: University of Utah, Huntsman Cancer Institute

location_facility: University Polyclinic Hospital "G. Martino", Department of Biomedical Sciences, Dentistry and Morphological and Functional Imaging, Complex Operational Unit of Nuclear Medicine

location_facility: Nantes University Hospital Center - Hotel Dieu Hospital

location_facility: University Hospital Complex of Santiago (CHUS)

location_facility: ICO Hospitalet, Catalan Institute of Oncology

location_facility: University of Colorado Hospital, Nuclear Medicine

location_facility: All India Institute Of Medical Sciences, Nuclear Medicine

location_facility: Edouard Herriot Hospital, Medical Oncology Unit

location_facility: Haut-Leveque Hospital, Department of Hepatogastroenterology and Digestive Tract Oncology

location_facility: Mayo Clinic - Rochester, Department of Oncology

location_facility: University Polyclinic Foundation "Agostino Gemelli" - IRCCS, Complex Operative Unit of Medical Oncology

location_facility: University Hospital 12 de Octubre, Department of Gastroenterology

location_facility: University Duisburg-Essen, University Hospital Essen, Clinic for Nuclear Medicine

location_facility: Central University Hospital de Asturias (HUCA), IUOPA - Universitary Institute of Oncology

location_facility: IUCT Oncopole - Institut Universitaire du Cancer de Toulouse

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: VU Medical Center (VUMC), Department of Medical Oncology