A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease
Trial ID or NCT#
NCT05662241
Status
RECRUITING
Purpose
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)
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. Males and females, ≥ 18 years of age2. Clinical diagnosis of IgG4-RD3. Patients must meet the 2019 ACR/EULAR Classification Criteria for IgG4-RD4. 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 therapy5. Other inclusion criteria apply
Exclusion Criteria:
- 1. Has disease in only 1 organ system whose primary manifestation is fibrosis2. Has received prednisone equivalent given orally at a dose greater than 60 mg/day within the 4 weeks prior to screening or during screening3. Has received a non-biologic, disease-modifying anti-rheumatological drug or immunosuppressive agent other than GCs within the 4 weeks prior to screening4. 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 screening5. Has received live vaccine or live therapeutic infectious agent within the 2 weeks prior to screening6. Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection7. Use of B cell depleting or targeting agents within 6 months of randomization8. Other exclusion criteria apply
Investigator(s)
Matthew C. Baker, MD MS
Immunologist,
Rheumatologist
Assistant Professor of Medicine (Immunology and Rheumatology)
View on ClinicalTrials.gov
