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

NCT ID: NCT06433999

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-28
• Study Completion Date: 2025-02-28

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.

Conditions

Dermatomyositis; Dermatomyositis, Adult Type

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brepocitinib

Group Type: EXPERIMENTAL

Brepocitinib

Intervention Type: DRUG

Oral Brepocitinib PO QD

Interventions

Brepocitinib

Oral Brepocitinib PO QD

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Priovant Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mangold, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Clinical Trial Site

Scottsdale, Arizona, United States

Countries

United States

Other Identifiers

PVT-2201-202

Identifier Type: -

Identifier Source: org_study_id