drugset / Trial / NCT02704429

A Study of PRN1008 in Adult Patients With Pemphigus Vulgaris

NCT02704429

Phase 2 Completed 42 enrolled Principia Biopharma, a Sanofi Company
NaSingle-groupOpen-labelTreatment

Summary

Open-label cohort study in adult patients with newly diagnosed or relapsing pemphigus vulgaris, with intra-patient dose-adjustment based on clinical response and BTK occupancy, and with conventional immunosuppressive "rescue treatment", if indicated. The duration of therapy in Part A will be 12 weeks, followed by 12 weeks of follow up. The extension phase, Part B includes 24 weeks of therapy, followed by 4 weeks of follow-up.

Timeline

Start
2016-01-22
Primary completion
2019-12-18
Completion
2020-01-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Rilzabrutinib Small molecule 400 mg Oral

Indications