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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: IgG4 Related Disease

In brief

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

Key facts

Study ID

NCT05662241

Run by

Zenas BioPharma (USA), LLC

People needed

194

Starts

2023-01-09

Expected to finish

2029-02-15

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females, ≥ 18 years of age
• Clinical diagnosis of IgG4-RD
• Patients must meet the 2019 ACR/EULAR Classification Criteria for IgG4-RD
• Patients must have active IgG4-RD signs/symptoms (i.e., flare) that require the initiation of GC therapy or the increase in background long-term GC therapy
• Other inclusion criteria apply

You may not qualify if…

• Has disease in only 1 organ system whose primary manifestation is fibrosis
• Has received prednisone equivalent given orally at a dose greater than 60 mg/day within the 4 weeks prior to screening or during screening
• Has received a non-biologic, disease-modifying anti-rheumatological drug or immunosuppressive agent other than GCs within the 2 weeks prior to screening
• Has received an investigational treatment or direct medical intervention on another clinical study within 12 weeks or < 5 half-lives of the investigational treatment, whichever is shorter, prior to screening
• Has received live vaccine or live therapeutic infectious agent within the 2 weeks prior to screening
• Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection
• Use of B cell depleting or targeting agents within 6 months of randomization
• Other exclusion criteria apply

Where it is running

• Ospedale San Giovanni Bosco — Turin, Piedmont, Italy
• 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

Full record on ClinicalTrials.gov

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