A Study of PRN1008 in Patients With Pemphigus

  • STATUS
    Recruiting
  • End date
    Mar 26, 2022
  • participants needed
    120
  • sponsor
    Principia Biopharma Inc.
Updated on 27 December 2020
Investigator
Regan Burns
Primary Contact
Central Recruiting (Principia Biopharma) (8.7 mi away) Contact
+158 other location
renal function
pemphigus foliaceus
autoantibody titer

Summary

This is a Phase 3 randomized, parallel-group, double-blind, placebo-controlled trial (Blinded Treatment Period) followed by an Open-Label Extension Period intended to evaluate the efficacy and safety of oral PRN1008 in moderate to severe pemphigus. After completing the Open-Label Extension Period, eligible patients may continue in a Long Term Extension Period of 48 weeks.

Description

Approximately 120 male or female patients with newly diagnosed or relapsing moderate to severe pemphigus (pemphigus vulgaris [PV] or pemphigus foliaceus [PF]) will be enrolled in the trial worldwide.

The trial will last 68 weeks (approximately 17 months) for each participant. For patients eligible to enroll in the Long Term Extension, the trial may last up to 116 weeks.

Patients will be randomized at Day 1, using a 1:1 ratio to receive PRN1008 or placebo twice per day, by relapsing/newly diagnosed disease history (newly diagnosed defined as within 6 months of Screening).

Details
Treatment Placebo Oral Tablet, PRN1008 Oral Tablet
Clinical Study IdentifierNCT03762265
SponsorPrincipia Biopharma Inc.
Last Modified on27 December 2020

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