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.
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).
|Treatment||Placebo Oral Tablet, PRN1008 Oral Tablet|
|Clinical Study Identifier||NCT03762265|
|Sponsor||Principia Biopharma Inc.|
|Last Modified on||27 December 2020|
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