Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)
Status:
Recruiting
Trial end date:
2024-11-01
Target enrollment:
Participant gender:
Summary
This is a two-part multi-center clinical trial in participants with active IgG4-RD.
Part 1 (Cohort 1a and Cohort 1B) is an open-label, dose escalation phase to determine the
safety of elotuzumab for investigation in IgG4-RD.
Part 2 (Cohort 2) is a randomized, placebo-controlled, double-blinded (masked) trial phase to
compare the effects of elotuzumab and prednisone to elotuzumab placebo and prednisone in
participants with IgG4 RD.
Approximately 75 participants with active IgG4-RD will be enrolled in the overall program, 12
in Part 1 and 63 in Part 2. Randomization in Part 2: 2 to 1, with approximately forty-two
participants randomized to elotuzumab plus prednisone taper, and twenty-one participants
randomized to placebo for elotuzumab plus prednisone taper.
The total duration of participant follow-up in this trial will be 48 weeks (11 months).
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators:
Autoimmunity Centers of Excellence Bristol-Myers Squibb Rho Federal Systems Division, Inc.