drugset / Trial / NCT02704429
A Study of PRN1008 in Adult Patients With Pemphigus Vulgaris
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rilzabrutinib | Small molecule | 400 mg | Oral |