Status:
COMPLETED
Open Label Two-Arm Study to Evaluate Rilzabrutinib in IgG4-Related Disease Participants
Lead Sponsor:
Principia Biopharma, a Sanofi Company
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Immunoglobulin G4 Related Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2a, multi-center, open-label, two-arm study of approximately 25 patients with active IgG4-related disease (IgG4-RD). The two arms include (1) Experimental: rilzabrutinib with glucocort...
Detailed Description
4 weeks of screening, 12 weeks of main treatment, 12 weeks of cross-over (for GC-only group), 40 weeks of extension treatment and 4-week follow-up.
Eligibility Criteria
Inclusion
- Key
- Be male or female with age ≥18 years.
- Have a clinical diagnosis of IgG4-RD.
- Be willing to taper off an equivalent prednisone dose of between 20-40 mg/day in 2 weeks.
- Key
Exclusion
- Currently or within 6 months of screening taking rituximab, other B-cell depleting agents, or alkylating agents unless B cell concentrations have been demonstrated by flow cytometry to return to normal values (defined as 5 cells per cubic mm).
- History of solid organ transplant
- Positive at Screening for HIV, hepatitis B, hepatitis C, or TB
- Female patients who are pregnant or nursing.
- NOTE: Other Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
August 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2024
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04520451
Start Date
August 22 2020
End Date
October 15 2024
Last Update
October 14 2025
Active Locations (9)
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1
Investigational Site Number 84019
Stanford, California, United States, 94305
2
Investigational Site Number 84016
Boston, Massachusetts, United States, 02114
3
Investigational Site Number 84018
Detroit, Michigan, United States, 48202
4
Investigational Site Number 84030
New York, New York, United States, 10021