A Study of PRN1008 in Patients With Pemphigus
Summary
This was a Phase 3 randomized, parallel-group, double-blind, placebo-controlled trial (blinded treatment \[BT\] period) followed by an open-label extension \[OLE\] period intended to evaluate the efficacy and safety of oral PRN1008 in moderate to severe pemphigus. After completing the open-label extension period, eligible participants might continue in a long term extension (LTE) Period of 48 weeks.
Timeline
- Start
- 2019-01-08
- Primary completion
- 2021-07-30
- Completion
- 2021-12-17
Outcome
Missed primary endpoint
Stopped (Business): “Sponsor decision based on lack of efficacy”
registry analysis (superiority test); Placebo Then Rilzabrutinib vs Rilzabrutinib Then Rilzabrutinib; p = 0.4469 NCT03762265 ↗
registry analysis (superiority test); Placebo Then Rilzabrutinib vs Rilzabrutinib Then Rilzabrutinib; p = 0.2510 NCT03762265 ↗
release “The Phase 3 PEGASUS trial evaluating rilzabrutinib to treat pemphigus, a rare autoimmune skin condition, did not meet its primary or key secondary endpoints.” sanofi.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rilzabrutinib | Unknown | 400 mg | Oral |