A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease
NCT ID: NCT05662241
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
194 participants
INTERVENTIONAL
2023-01-09
2029-02-15
Brief Summary
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Detailed Description
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To enter the Screening Period (Day -28 to Day -1), patients must have active IgG4-RD signs/symptoms (i.e., flare) that require steroid therapy. On Day 1, patients will be randomized in a ratio of 1:1 to receive either obexelimab or placebo administered as subcutaneous (SC) injections. All patients will begin a steroid taper on Day 1 to discontinuation by Week 8.
Patients will be monitored for flares during scheduled in clinic visits and any unscheduled visits. The primary endpoint is time to first IgG4-RD flare that requires initiation of rescue therapy in the opinion of the investigator and the Adjudication Committee (AC).
Following the 52-week RCP, patients will have the opportunity to continue in an OLE period where all patients will receive obexelimab. During the OLE, a subset of patients may be eligible to participate in a sub-study evaluating the immune response to vaccination while receiving obexelimab treatment. Patients who do not wish to enroll into the OLE period will return for an in-clinic safety follow-up visit 8 weeks after the Week 52 visit (i.e., Week 60).
Including screening and follow-up, the maximum duration of participation in this study for an individual patient is 224 weeks (i.e., 28-day screening, 52-week RCP, 156-week OLE, and a 12-week follow-up).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ZB012
Obexelimab administered as an SC injection.
Obexelimab
Obexelimab is a monoclonal antibody that co-engages CD19 and FcγRIIb to inhibit B cell activity
Placebo
Placebo administered as an SC injection.
Placebo
Placebo
Interventions
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Obexelimab
Obexelimab is a monoclonal antibody that co-engages CD19 and FcγRIIb to inhibit B cell activity
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of IgG4-RD
3. Patients must meet the 2019 ACR/EULAR Classification Criteria for IgG4-RD
4. 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
Exclusion Criteria
2. Has received prednisone equivalent given orally at a dose greater than 60 mg/day within the 4 weeks prior to screening or during screening
3. Has received a non-biologic, disease-modifying anti-rheumatological drug or immunosuppressive agent other than GCs within the 2 weeks prior to screening
4. 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
5. Has received live vaccine or live therapeutic infectious agent within the 2 weeks prior to screening
6. Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection
7. Use of B cell depleting or targeting agents within 6 months of randomization
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Zenas BioPharma (USA), LLC
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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ZB012-03-001
Identifier Type: -
Identifier Source: org_study_id
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