A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis
Public ClinicalTrials.gov record NCT05437263. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults With Dermatomyositis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05437263
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 241 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2022 (Actual)
- Primary completion
- Jul 17, 2025 (Actual)
- Completion
- Sep 9, 2026 (Actual)
- Last update posted
- Sep 15, 2026
2022 – 2026
United States locations
- U.S. sites
- 39
- U.S. states
- 20
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Trial Site | Phoenix | Arizona | 85028 | — |
| Clinical Trial Site | Scottsdale | Arizona | 85258 | — |
| Clinical Trial Site | Scottsdale | Arizona | 85259 | — |
| Clinical Trial Site | Irvine | California | 92617 | — |
| Clinical Trial Site | Los Angeles | California | 90095 | — |
| Clinical Trial Site | San Francisco | California | 94115 | — |
| Clinical Trial Site | Aurora | Colorado | 80045 | — |
| Clinical Trial Site | Denver | Colorado | 80230 | — |
| Clinical Trial Site | Boynton Beach | Florida | 33472 | — |
| Clinical Trial Site | Gainesville | Florida | 32606 | — |
| Clinical Trial Site | Jacksonville | Florida | 32224 | — |
| Clinical Trial Site | Plantation | Florida | 33324 | — |
| Clinical Trial Site | Tampa | Florida | 33613 | — |
| Clinical Trial Site | Atlanta | Georgia | 30322 | — |
| Clinical Trial Site | Augusta | Georgia | 30912 | — |
| Clinical Trial Site | Marietta | Georgia | 30060 | — |
| Clinical Trial Site | Chicago | Illinois | 60637 | — |
| Clinical Trial Site | Iowa City | Iowa | 52242 | — |
| Clinical Trial Site | Kansas City | Kansas | 66160 | — |
| Clinical Trial Site | New Orleans | Louisiana | 70112 | — |
| Clinical Trial Site | New Orleans | Louisiana | 70433 | — |
| Clinical Trial Site | Baltimore | Maryland | 21224 | — |
| Clinical Trial Site | Boston | Massachusetts | 02115 | — |
| Clinical Trial Site | Ann Arbor | Michigan | 48103 | — |
| Clinical Trial Site | Minneapolis | Minnesota | 55455 | — |
| Clinical Trial Site | Rochester | Minnesota | 55905 | — |
| Clinical Trial Site | Manhasset | New York | 11030 | — |
| Clinical Trial Site | New York | New York | 10017 | — |
| Clinical Trial Site | New York | New York | 10021 | — |
| Clinical Trial Site | Cincinnati | Ohio | 45267 | — |
| Clinical Trial Site | Cleveland | Ohio | 44195 | — |
| Clinical Trial Site | Oklahoma City | Oklahoma | 73116 | — |
| Clinical Trial Site | Portland | Oregon | 97239 | — |
| Clinical Trial Site | Philadelphia | Pennsylvania | 19104 | — |
| Clinical Trial Site | Pittsburgh | Pennsylvania | 15213 | — |
| Clinical Trial Site | Jackson | Tennessee | 38305 | — |
| Clinical Trial Site | Austin | Texas | 78756 | — |
| Clinical Trial Site | Houston | Texas | 77030 | — |
| Clinical Trial Site | Irving | Texas | 75039 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 70 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05437263, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 15, 2026 · Synced Oct 30, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05437263 live on ClinicalTrials.gov.