IgG4 Related Disease
Conditions
Keywords
IgG4, IgG4-RD
Brief summary
This study aims to examine the efficacy and safety of obexelimab for the prevention of flare of IgG4-related disease (IgG4-RD)
Detailed description
This study consists of a 1-year randomized control period (RCP), followed by an additional 3-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. During the OLE, a subset of patients may be eligible to participate in a sub-study evaluating the immune response to vaccination while receiving obexelimab treatment. 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 224 weeks (i.e., 28-day screening, 52-week RCP, 156-week OLE, and a 12-week follow-up).
Interventions
DRUGObexelimab
Obexelimab is a monoclonal antibody that co-engages CD19 and FcγRIIb to inhibit B cell activity
OTHERPlacebo
Placebo
Sponsors
Zenas BioPharma (USA), LLC
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome measure | 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. |
Countries
Argentina, Canada, China, France, Germany, Italy, Japan, Mexico, Poland, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed