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

This study aims to examine the efficacy and safety of obexelimab for the prevention of flare of IgG4-related disease (IgG4-RD)

Inclusion Criteria:Males and females, ≥ 18 years of ageClinical diagnosis of IgG4-RDPatients must meet the 2019 ACR/EULAR Classification Criteria for IgG4-RDPatients 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 therapyOther inclusion criteria applyExclusion Criteria:Has disease in only 1 organ system whose primary manifestation is fibrosisHas received prednisone equivalent given orally at a dose greater than 60 mg/day within the 4 weeks prior to screening or during screeningHas received a non-biologic, disease-modifying anti-rheumatological drug or immunosuppressive agent other than GCs within the 4 weeks prior to screeningHas 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 screeningHas received live vaccine or live therapeutic infectious agent within the 2 weeks prior to screeningActive tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infectionUse of B cell depleting or targeting agents within 6 months of randomizationOther exclusion criteria apply