A 12-Week Open-Label Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Skin-Predominant Dermatomyositis

Phase 2

Completed

• Conditions: Dermatomyositis; Dermatomyositis, Adult Type
• Interventions: Drug: Brepocitinib

• Registration Number: NCT06433999
• Lead Sponsor: Priovant Therapeutics, Inc.

Brief Summary

This is a prospective, 12-week, open-label, single-arm study. The study population comprises individuals with refractory skin disease characteristic of dermatomyositis with no to minimal muscle involvement. After an up to 8-week Screening Period, eligible participants will receive brepocitinib 30 mg orally (PO) QD for 12 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-23
• Study First Submitted QC: 2024-05-23
• Study First Posted: 2024-05-30
• Study Start: 2024-08-28
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies
• Active cutaneous manifestations of dermatomyositis
• Adult subjects (18-75 years old)
• Weight > 40 kg to < 130 kg, and with a body mass index (BMI) < 40 kg/m2.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brepocitinib	Brepocitinib	-

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the change in CDASI-A score from baseline through Week 12	12 weeks

Trial Locations

Locations (1)

Clinical Trial Site; 🇺🇸 Scottsdale, Arizona, United States