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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults with Dermatomyositis

IRB Number: 2022-0733

Institutional Review Board, Hospital for Special Surgery

December 13, 2023

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

David R. Fernandez, MD, PhD

Co-Investigators

Robert F. Spiera, MD
Jessica K. Gordon, MD
Lindsay S. Lally, MD
Kimberly Lakin, MD, MS

Summary

This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK.2/JAKl inhibitor) in adults with dermatomyositis (OM). The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to placebo, as measured by differences in the Total Improvement Score (TIS). After 52 weeks of double-blind treatment, participants may have the option to continue therapy in a 52 week open-label extension phase where all participants will receive brepocitinib. There is a 4 week follow-up period. 
Target enrollment: 3 

Inclusion/Exclusion 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, an antimalarial, 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 screening ( 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 Sjogren'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

Contact Information

Liza Morales 
212.774.2561 
moralesli@hss.edu