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ACTIVE NOT RECRUITING
NCT05662241
PHASE3

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

Sponsor: Zenas BioPharma (USA), LLC

View on ClinicalTrials.gov

Summary

This study aims to examine the efficacy and safety of obexelimab for the prevention of flare of IgG4-related disease (IgG4-RD)

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With IgG4-Related Disease (INDIGO)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

194

Start Date

2023-01-09

Completion Date

2029-02-15

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

DRUG

Obexelimab

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

OTHER

Placebo

Placebo

Locations (65)

Stanford Medicine

Stanford, California, United States

GI PROS Research - Dedicated Research Facility

Naples, Florida, United States

Emory Univeristy

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Artus Health Centre

Vancouver, British Columbia, Canada

Center for Clinical Research (Nova Scotia Health)

Halifax, Nova Scotia, Canada

Centre Hospitalier Universitaire de Sherbrooke CHUS

Sherbrooke, Quebec, Canada

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

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

Wuhai, Hubei, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Haut-Lévèque Hospital Usn Building South Hospital Group

Pessac, Bordeaux, France

Hôpitaux Universitaires de Marseille Timone

Saint-Pierre, Marseille, France

Hôpital Beaujon

Paris, France

Hôpital de la Pitié Salpétrière

Paris, France

LMU Klinikum der Universität München

München, Bavaria, Germany

Universitätsklinikum Ulm

Ulm, Germany

Ospedale San Giovanni Bosco

Turin, Piedmont, Italy

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brescia, Italy

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

Florence, Italy

Ospedale San Raffaele S.r.l. - PPDS

Milan, Italy

University of Verona

Verona, Italy

Hospital of University of Occupational and Environmental Health

Kitakyushu, Fukuoka, Japan

Kanazawa Medical University Hospital

Kokura, Fukuoka, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Kagawa University Hospital

Hiragi, Kagawa-ken, Japan

Shinshu University Hospital

Matsumoto, Nagano, Japan

Osaka Metropolitan University Hospital

Osaka, Osaka, Japan

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Bunkyō-Ku, Tokyo, Japan

The Institute of Medical Science, The University of Tokyo Hospital

Minato-ku, Tokyo, Japan

Keio University Hospital

Shinjuku-Ku, Tokyo, Japan

Toyama University Hospital

Toyama, Toyama, Japan

Kansai Medical University Hospital

Hirakata, Japan

Hiroshima University Hospital

Hiroshima, Japan

St. Marianna University Hospital

Kawasaki, Japan

Tokyo Medical Center Hospital

Meguro City, Japan

Nagaoka Red Cross Hospital

Nagaoka, Japan

Nagasaki University Hospital

Nagasaki, Japan

Kita-Harima Medical Center

Ono, Japan

Tazuke Kofukai Medical Research Institute Kitano Hospital

Osaka, Japan

Sapporo Medical University Hospital

Sapporo, Japan

Fujita Health University Hospital

Shinjuku-Ku, Japan

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico City, Mexico

Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC

San Luis Potosí City, Mexico

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

Warsaw, Masovian Voivodeship, Poland

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

Bydgoszcz, Poland

Seoul National University Hospital

Seoul, Seoul, South Korea

Ajou University Hospital

Suwon, South Korea

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Vall d'Hebron University Hospital

Barcelona, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Hacettepe University Faculty of Medicine

Altındağ, Ankara, Turkey (Türkiye)

Marmara University Pendik Training and Research Hospital

Pendik, Istanbul, Turkey (Türkiye)

John Radcliffe Hospital

Oxford, United Kingdom