drugset / Trial / NCT03762265

A Study of PRN1008 in Patients With Pemphigus

NCT03762265

Phase 3 Terminated 131 enrolled Principia Biopharma, a Sanofi Company
RandomizedParallel-groupQuadruple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Rilzabrutinib Small molecule 400 mg Oral

Indications