An Open Label, Two-Arm Study to Evaluate the Effect of Rilzabrutinib (PRN1008/SAR444671) on Safety and Disease Activity in Patients With IgG4-Related Disease
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- STATUS
- Recruiting
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- End date
- Sep 18, 2024
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- participants needed
- 25
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- sponsor
- Principia Biopharma, a Sanofi Company
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 glucocorticoids and (2) Active Comparator: glucocorticoids only.
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.
Details
| Condition | Immunoglobulin G4 Related Disease |
|---|---|
| Treatment | Glucocorticoids, rilzabrutinib |
| Clinical Study Identifier | NCT04520451 |
| Sponsor | Principia Biopharma, a Sanofi Company |
| Last Modified on | 21 October 2022 |
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