A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease
INDIGO
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)
1 other identifier
interventional
194
15 countries
65
Brief Summary
This study aims to examine the efficacy and safety of obexelimab for the prevention of flare of IgG4-related disease (IgG4-RD)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2023
Longer than P75 for phase_3
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2022
CompletedFirst Posted
Study publicly available on registry
December 22, 2022
CompletedStudy Start
First participant enrolled
January 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2029
ExpectedFebruary 4, 2026
February 1, 2026
2.8 years
December 14, 2022
February 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary outcome measure
Time to first IgG4-RD flare, defined as the reappearance of previous signs/symptoms or appearance of new signs/symptoms of IgG4-RD that requires initiation of rescue therapy in the opinion of the investigator and the Adjudication Committee (AC), from randomization to Week 52.
Randomization to Week 52
Other Outcomes (1)
Vaccine antibody titers
During the 3 year OLE period
Study Arms (2)
ZB012
EXPERIMENTALObexelimab administered as an SC injection.
Placebo
PLACEBO COMPARATORPlacebo administered as an SC injection.
Interventions
Obexelimab is a monoclonal antibody that co-engages CD19 and FcγRIIb to inhibit B cell activity
Eligibility Criteria
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
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zenas BioPharma (USA), LLClead
- Bristol-Myers Squibbcollaborator
Study Sites (65)
Stanford Medicine
Stanford, California, 94305, United States
GI PROS Research - Dedicated Research Facility
Naples, Florida, 34102, United States
Emory Univeristy
Atlanta, Georgia, 30322, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Henry Ford Hospital
Detroit, Michigan, 48202, 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, 33604, France
Hôpitaux Universitaires de Marseille Timone
Saint-Pierre, Marseille, 13005, 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, 10128, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, 25123, 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, 37134, Italy
Hospital of University of Occupational and Environmental Health
Kitakyushu, Fukuoka, 807-8555, 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, 390-8621, 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, 03080, South Korea
Ajou University Hospital
Suwon, 206, South Korea
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Vall d'Hebron University Hospital
Barcelona, 08035, 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, 333, Taiwan
Hacettepe University Faculty of Medicine
Altındağ, Ankara, 06230, Turkey (Türkiye)
Marmara University Pendik Training and Research Hospital
Pendik, Istanbul, Turkey (Türkiye)
John Radcliffe Hospital
Oxford, United Kingdom
Related Publications (1)
Culver EL, Baker MC, Della-Torre E, Zhang W, Perugino CA, Wells A, Mamuye A, Quinn SM, Poma A, Greene TJ, Stone JH. Efficacy and Safety of Obexelimab to Treat IgG4-Related Disease: Protocol for a Global, Randomized, Placebo-Controlled Trial. Rheumatol Ther. 2026 Mar 16. doi: 10.1007/s40744-026-00835-4. Online ahead of print.
PMID: 41840328DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2022
First Posted
December 22, 2022
Study Start
January 9, 2023
Primary Completion
November 13, 2025
Study Completion (Estimated)
February 15, 2029
Last Updated
February 4, 2026
Record last verified: 2026-02