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NCT05437263 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis
A Phase 3 study of Dermatomyositis, sponsored by Priovant Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 241
- Enrollment target
- 20
- Study locations
NCT05437263: Active Phase 3 study of Dermatomyositis, sponsored by Priovant Therapeutics.
NCT05437263 is a Phase 3 study of Dermatomyositis that is active but no longer recruiting, run by Priovant Therapeutics. The registered enrollment target is 241 participants, below the 472-participant average among 19 other Dermatomyositis trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05437263, a Phase 3 study of Dermatomyositis, is active but no longer recruiting, sponsored by Priovant Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 241 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to placebo, as measured by differences in the Total Improvement Score (TIS). After 52 weeks of double-blind treatment, participants have the option to continue therapy in a 52 week open-label extension phase where all participants will receive brepocitinib.
Primary Outcome
TIS is a composite endpoint based on improvement in the 6 Disease Activity Core Set Measure (CSM) scores and ranges from 0 to 100 (2016 American College of Rheumatology \[ACR\] Myositis Response Criteria/European League Against Rheumatism \[EULAR\]) where a higher score indicates more improvement
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Brepocitinib
Study Locations (20)
Florida
- Clinical Trial Site - Boynton Beach
- Clinical Trial Site - Gainesville
- Clinical Trial Site - Jacksonville
- Clinical Trial Site - Plantation
- Clinical Trial Site - Tampa
Arizona
- Clinical Trial Site - Phoenix
- Clinical Trial Site - Scottsdale
- Clinical Trial Site - Scottsdale
California
- Clinical Trial Site - Irvine
- Clinical Trial Site - Los Angeles
- Clinical Trial Site - San Francisco
Georgia
- Clinical Trial Site - Atlanta
- Clinical Trial Site - Augusta
- Clinical Trial Site - Marietta
Colorado
- Clinical Trial Site - Aurora
- Clinical Trial Site - Denver
Illinois
- Clinical Trial Site - Chicago
Iowa
- Clinical Trial Site - Iowa City
Kansas
- Clinical Trial Site - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2022-10-31 |
| Est. Completion | 2026-07 |
| Phase | Phase 3 |
What the registry record for NCT05437263 still lists
NCT05437263 is an interventional study that assigns participants to a tested intervention. The registered 241 participants enrollment target is mid-sized for trials with a published cap, below the 472-participant average among 19 other Dermatomyositis trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Dermatomyositis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05437263 names 20 study sites across 9 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT05437263 about?
NCT05437263 is a clinical study titled "A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis". This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to placebo, as m...
What is the current status of trial NCT05437263?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 241 participants. The study started on 2022-10-31. Estimated completion is 2026-07.
What conditions does trial NCT05437263 study?
This clinical trial studies the following conditions: Dermatomyositis.
What interventions are being tested in trial NCT05437263?
The interventions under investigation include: Placebo (DRUG), Brepocitinib (DRUG).
Who is sponsoring clinical trial NCT05437263?
This trial is sponsored by Priovant Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05437263 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05437263's enrollment target sits among peer trials
241 8th of 19 higher than 12 of 19 other Dermatomyositis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dermatomyositis 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.
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