Active IgG4 related disease
Conditions
Interventions
Obexelimab or placebo is administered as SC injections every 7 days during the Randomized Controlled Period. Obexelimab is administered as SC injections every 7 days during the open-label extension p
Sponsors
Zhang Changliang
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Males and females, 18 years of age and over 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
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 4 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
ARGENTINA, CANADA, CHINA, FRANCE, GERMANY, HONG KONG, HUNGARY, ITALY, Japan, KOREA, MEXICO, NETHERLANDS, POLAND, SPAIN, SWEDEN, TAIWAN, TURKEY, UNITED KINGDOM, UNITED STATES
Contacts
Public ContactChangliang Zhang
Bristol-Myers Squibb
Outcome results
None listed