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NCT03762265 · ClinicalTrials.gov registry record · Phase 3
A Study of PRN1008 in Patients With Pemphigus
A Phase 3 study, sponsored by Principia Biopharma, a Sanofi Company.
- Terminated
- Registry status
- Phase 3
- Development phase
- 131
- Enrollment target
NCT03762265: Clinical Trial Phase 3 study, sponsored by Principia Biopharma, a Sanofi Company.
NCT03762265 is a Phase 3 study that was terminated before completion, run by Principia Biopharma, a Sanofi Company. The registered enrollment target is 131 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03762265, a Phase 3 study, was terminated before completion, sponsored by Principia Biopharma, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 131 participants
- Enrollment target
Study 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.
Primary Outcome
Complete remission was defined as absence of new and established lesions and was intended to mean "no disease activity" for 2 consecutive weeks, with Pemphigus Disease Area Index (PDAI) activity score =0 and CS dose \<=10 mg. PDAI score weighted for number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). PDAI total score ranged from 0 to 250 points representing disease ac
Interventions
- DRUG Placebo
- DRUG Rilzabrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2019-01-08 |
| Est. Completion | 2021-12-17 |
| Phase | Phase 3 |
Why NCT03762265 stopped before completion
NCT03762265 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03762265 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03762265 about?
NCT03762265 is a clinical study titled "A Study of PRN1008 in Patients With Pemphigus". 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 ext...
What is the current status of trial NCT03762265?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 131 participants. The study started on 2019-01-08. Estimated completion is 2021-12-17.
What interventions are being tested in trial NCT03762265?
The interventions under investigation include: Placebo (DRUG), Rilzabrutinib (DRUG).
Who is sponsoring clinical trial NCT03762265?
This trial is sponsored by Principia Biopharma, a Sanofi Company, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03762265's enrollment target sits among peer trials
131 1593rd of 2000 higher than 407 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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