A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Dermatomyositis
In brief
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.
Key facts
- Study ID
- NCT05437263
- Run by
- Priovant Therapeutics, Inc.
- People needed
- 241
- Starts
- 2022-10-31
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies
- Adult subjects (18-75 years old)
- Active muscle and skin disease at screening and baseline
- Prior therapy OR current therapy with corticosteroids, hydroxychloroquine, and/or one non-steroid immunosuppressant
- Weight > 40 kg to < 130 kg, and with a body mass index (BMI) < 40 kg/m2.
You may not qualify if…
- Dermatomyositis with end-stage organ involvement
- Dermatomyositis with irreversible muscle involvement
- History of:
- Any lymphoproliferative disorder
- Active malignancy;
- History of cancer within 5 years prior to randomization (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.)
- Cancer-associated dermatomyositis
- Overlap myositis/connective tissue disease (except for overlap with Sjögren's syndrome)
- Participants at a risk of thrombosis or cardiovascular disease
- Participants with a high risk for herpes zoster reactivation
- Participants with active or recent infections
Where it is running
- Clinical Trial Site — Santiago, Chile
- Clinical Trial Site — Phoenix, Arizona, United States
- Clinical Trial Site — Scottsdale, Arizona, United States
- Clinical Trial Site — Scottsdale, Arizona, United States
- Clinical Trial Site — Irvine, California, United States
- Clinical Trial Site — Los Angeles, California, United States
- Clinical Trial Site — San Francisco, California, United States
- Clinical Trial Site — Aurora, Colorado, United States
- Clinical Trial Site — Denver, Colorado, United States
- Clinical Trial Site — Boynton Beach, Florida, United States
- Clinical Trial Site — Gainesville, Florida, United States
- Clinical Trial Site — Jacksonville, Florida, United States
- Clinical Trial Site — Plantation, Florida, United States
- Clinical Trial Site — Tampa, Florida, United States
- Clinical Trial Site — Atlanta, Georgia, United States
- Clinical Trial Site — Augusta, Georgia, United States
- Clinical Trial Site — Marietta, Georgia, United States
- Clinical Trial Site — Chicago, Illinois, United States
- Clinical Trial Site — Iowa City, Iowa, United States
- Clinical Trial Site — Kansas City, Kansas, United States
- Clinical Trial Site — New Orleans, Louisiana, United States
- Clinical Trial Site — New Orleans, Louisiana, United States
- Clinical Trial Site — Baltimore, Maryland, United States
- Clinical Trial Site — Boston, Massachusetts, United States
- Clinical Trial Site — Santiago, Chile
Full record on ClinicalTrials.gov
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