A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease (INDIGO)
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|ClinicalTrials.gov Identifier: NCT05662241|
Recruitment Status : Recruiting
First Posted : December 22, 2022
Last Update Posted : March 20, 2023
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|Condition or disease||Intervention/treatment||Phase|
|IgG4 Related Disease||Drug: Obexelimab Other: Placebo||Phase 3|
This study consists of a 1-year randomized control period (RCP), followed by an additional 1-year open label extension (OLE) period.
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. 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 116 weeks (i.e., 28-day screening, 52-week RCP, 52-week OLE, and an 8-week follow-up).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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)|
|Actual Study Start Date :||September 30, 2022|
|Estimated Primary Completion Date :||October 31, 2025|
|Estimated Study Completion Date :||December 31, 2026|
Obexelimab administered as an SC injection.
Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcγRIIb, resulting in down regulation of B cell activity.
Placebo Comparator: Placebo
Placebo administered as an SC injection.
- Primary outcome measure [ Time Frame: Randomization to Week 52 ]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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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 4 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05662241
|Contact: Patient and Medical Information||833-269-4696||Clinicaltrialsinfo@zenasbio.com|
|Contact: Zenas Patient Centerfirstname.lastname@example.org|
|United States, California|
|Stanford, California, United States, 94305|
|Allergy & Asthma Clinical Research- Dedicated Research Facility||Recruiting|
|Walnut Creek, California, United States, 94598|
|United States, Florida|
|GI PROS Research - Dedicated Research Facility||Recruiting|
|Naples, Florida, United States, 34102|
|United States, Illinois|
|Rush University Medical Center||Recruiting|
|Chicago, Illinois, United States, 60612|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Responsible Party:||Zenas BioPharma (USA), LLC|
|Other Study ID Numbers:||
|First Posted:||December 22, 2022 Key Record Dates|
|Last Update Posted:||March 20, 2023|
|Last Verified:||January 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Immunoglobulin G4-Related Disease
Immune System Diseases