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

Last updated: May 15, 2025
Sponsor: Priovant Therapeutics, Inc.
Overall Status: Completed

Phase

2

Condition

Lupus

Connective Tissue Diseases

Idiopathic Inflammatory Myopathies

Treatment

Brepocitinib 30 mg

Brepocitinib

Clinical Study ID

NCT06433999
PVT-2201-202
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteriafor 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

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 cellcarcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast,carcinoma in situ of the uterine cervix, or thyroid carcinoma.) Cancer-associateddermatomyositis

  • Overlap myositis/connective tissue disease (except for overlap with Sjögren'ssyndrome)

  • 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

Total Participants: 5
Treatment Group(s): 2
Primary Treatment: Brepocitinib 30 mg
Phase: 2
Study Start date:
August 28, 2024
Estimated Completion Date:
February 28, 2025

Connect with a study center

  • Clinical Trial Site

    Scottsdale, Arizona 85259
    United States

    Site Not Available

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