Status:
ACTIVE_NOT_RECRUITING
A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis
Lead Sponsor:
Priovant Therapeutics, Inc.
Conditions:
Dermatomyositis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT05437263
Start Date
October 31 2022
End Date
July 1 2026
Last Update
September 29 2025
Active Locations (109)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Trial Site
Phoenix, Arizona, United States, 85028
2
Clinical Trial Site
Scottsdale, Arizona, United States, 85258
3
Clinical Trial Site
Scottsdale, Arizona, United States, 85259
4
Clinical Trial Site
Irvine, California, United States, 92617