A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

194

Participants

Timeline

Start Date

September 30, 2022

Primary Completion Date

November 15, 2025

Study Completion Date

February 15, 2029

Conditions
IgG4 Related Disease
Interventions
DRUG

Obexelimab

Obexelimab is a monoclonal antibody that co-engages CD19 and FcγRIIb to inhibit B cell activity

OTHER

Placebo

Placebo

Trial Locations (65)

206

Ajou University Hospital, Suwon

333

Linkou Chang Gung Memorial Hospital, Taoyuan District

10128

Ospedale San Giovanni Bosco, Turin

13005

Hôpitaux Universitaires de Marseille Timone, Saint-Pierre

25123

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Brescia

28034

Hospital Universitario Ramón y Cajal, Madrid

30322

Emory Univeristy, Atlanta

33604

Haut-Lévèque Hospital Usn Building South Hospital Group, Pessac

34102

GI PROS Research - Dedicated Research Facility, Naples

37134

University of Verona, Verona

48202

Henry Ford Hospital, Detroit

94305

Stanford Medicine, Stanford

02114

Massachusetts General Hospital, Boston

Unknown

Hospital Italiano de Buenos Aires, Buenos Aires

Artus Health Centre, Vancouver

Center for Clinical Research (Nova Scotia Health), Halifax

Centre Hospitalier Universitaire de Sherbrooke CHUS, Sherbrooke

Chinese PLA General Hospital, Beijing

Peking Union Medical College Hospital, Beijing

Peking University First Hospital, Beijing

The Second Hospital of Hebei Medical University, Shijiazhuang

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhai

Yantai Yuhuangding Hospital, Yantai

Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai

Shanxi Bethune Hospital, Taiyuan

West China Hospital of Sichuan University, Chengdu

Hôpital Beaujon, Paris

Hôpital de la Pitié Salpétrière, Paris

LMU Klinikum der Universität München, München

Universitätsklinikum Ulm, Ulm

Azienda Ospedaliera Universitaria Meyer Istituto di Ricovero e Cura a Carattere Scientifico, Florence

Ospedale San Raffaele S.r.l. - PPDS, Milan

Kanazawa Medical University Hospital, Kokura

Kanazawa University Hospital, Kanazawa

Kagawa University Hospital, Hiragi

Osaka Metropolitan University Hospital, Osaka

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Bunkyō-Ku

The Institute of Medical Science, The University of Tokyo Hospital, Minato-ku

Keio University Hospital, Shinjuku-Ku

Toyama University Hospital, Toyama

Kansai Medical University Hospital, Hirakata

Hiroshima University Hospital, Hiroshima

St. Marianna University Hospital, Kawasaki

Tokyo Medical Center Hospital, Meguro City

Nagaoka Red Cross Hospital, Nagaoka

Nagasaki University Hospital, Nagasaki

Kita-Harima Medical Center, Ono

Tazuke Kofukai Medical Research Institute Kitano Hospital, Osaka

Sapporo Medical University Hospital, Sapporo

Fujita Health University Hospital, Shinjuku-Ku

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City

Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC, San Luis Potosí City

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher, Warsaw

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Bydgoszcz

Hospital Universitario Virgen del Rocio, Seville

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

Taipei Veterans General Hospital, Taipei

Marmara University Pendik Training and Research Hospital, Pendik

John Radcliffe Hospital, Oxford

807-8555

Hospital of University of Occupational and Environmental Health, Kitakyushu

390-8621

Shinshu University Hospital, Matsumoto

03080

Seoul National University Hospital, Seoul

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

08035

Vall d'Hebron University Hospital, Barcelona

06230

Hacettepe University Faculty of Medicine, Altındağ

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Zenas BioPharma (USA), LLC

INDUSTRY

NCT05662241 - A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease | Biotech Hunter | Biotech Hunter