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

NCT06433999 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: PVT-2201-202
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Keywords

skin-predominant dermatomyositis; dermatomyositis

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the change in CDASI-A score from baseline through Week 12

  12 weeks

Study Arms (1)

Brepocitinib

EXPERIMENTAL

Drug: Brepocitinib

Interventions

Brepocitinib DRUG

Oral Brepocitinib PO QD

Brepocitinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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

Sponsors & Collaborators

• Priovant Therapeutics, Inc.: lead

Study Sites (1)

Clinical Trial Site

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Dermatomyositis

Condition Hierarchy (Ancestors)

Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Mangold, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: August 28, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)