Trials / Completed
CompletedNCT04520451
Open Label Two-Arm Study to Evaluate Rilzabrutinib in IgG4-Related Disease Participants
An Open Label, Two-Arm Study to Evaluate the Effect of Rilzabrutinib (PRN1008/SAR444671) on Safety and Disease Activity in ParticipantsWith IgG4-Related Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Principia Biopharma, a Sanofi Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rilzabrutinib | oral tablet |
| DRUG | Glucocorticoids | oral tablet or capsule |
Timeline
- Start date
- 2020-08-22
- Primary completion
- 2024-10-15
- Completion
- 2024-10-15
- First posted
- 2020-08-20
- Last updated
- 2025-10-14
Locations
9 sites across 5 countries: United States, Canada, France, Italy, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04520451. Inclusion in this directory is not an endorsement.