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

Inclusion Criteria: 1. Males and females, ≥ 18 years of age 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 5. Other inclusion criteria apply Exclusion Criteria: 1. Has disease in only 1 organ system whose primary manifestation is fibrosis 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 8. Other exclusion criteria apply