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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 is a Phase 3 study that was terminated before completion, run by Principia Biopharma, a Sanofi Company. The registered enrollment target is 131 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03762265
The ClinicalTrials.gov registry entry for NCT03762265 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Principia Biopharma, a Sanofi Company, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03762265 reports 0 study locations.
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.
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