Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Dermatomyositis
• Age: Between 18 Year(s) - 75 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Male or female, and the participant must be ≥ 18 to < 75 years of age at the time of signing the informed consent form (ICF).
  2. Participants with a diagnosis of dermatomyositis.
  3. Active cutaneous manifestation of dermatomyositis documented as part of the investigator's exam.
  4. Current therapy consisting of corticosteroid = 20 mg/day.
  5. At most, one non-steroid immunomodulatory/immunosuppressive therapy, with a stable dose for at least 12 weeks prior to screening.
  6. Participants weighing > 40 kg to < 130 kg, and with a body mass index (BMI) < 40 kg/m2.
  7. Participants who have received a vaccination regimen for COVID-19 at least 2 weeks prior to randomization.
  8. Participants who have received at least 1 dose of a herpes zoster vaccine (if consistent with local guidelines and based on participant age and comorbid conditions) at least 6 weeks prior to randomization.

  
  

You may not be eligible for this study if the following are true:

• 1. Recently started (< 4 weeks prior to screening) or planning to start a physical therapy directed or other scheduled/planned/supervised exercise regimen during the study.
  2. Have had significant trauma or major surgery or blood transfusion within 4 weeks of screening or scheduled to occur during the study.
  3. History of alcohol or drug abuse, in the investigator’s opinion, unless in full remission for greater than 12 months prior to randomization.
  4. Women who are breastfeeding, pregnant, or planning to become pregnant, or women of childbearing potential who are unwilling to apply a highly effective birth control method.
  5. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Priovant Therapeutics, Inc. or affiliate employees, including their family members, directly involved in the conduct of the study.
  6. Dermatomyositis with end-stage organ involvement.
  7. Dermatomyositis with irreversible muscle involvement.
  8. Calcinosis that is motion-limiting and would prevent accurate assessment of disease activity.
  9. History of any lymphoproliferative disorder.
  10. Cancer-associated condition, cancer, or history.
  11. Participants with overlap myositis/connective tissue disease associated dermatomyositis.
  12. Participants with generalized, severe musculoskeletal or neuro-muscular conditions other than dermatomyositis that prevent a sufficient assessment of the participant by the investigator, such as severe fibromyalgia, severe osteoarthritis, severe rheumatoid arthritis, multiple sclerosis, etc.
  13. Severe liver disease.
  14. History of thrombosis (venous or arterial) or ischemic cerebrovascular event (stroke or transient ischemic attack [TIA]) within 3 years prior to screening.
  15. A history of cardiac insufficiency.
  16. Clinically significant cardiac dysrhythmia.
  17. Unstable angina within 3 months of screening.
  18. Myocardial infarction (MI) within 1 year prior to screening.
  19. Coronary artery bypass graft surgery within 1 year prior to screening.
  20. Recipient of a solid organ transplant who is currently receiving systemic immunosuppressive therapy.
  21. Any condition possibly affecting oral drug absorption.
  22. Treatment-naive (i.e., no prior dermatomyositis therapy with corticosteroids or other immunosuppressive agents).
  23. Prior exposure to brepocitinib, or participation in a brepocitinib clinical trial.
  24. History of severe allergic or anaphylactoid reaction to any constituents of the study drug formulation or other JAK inhibitors.
  25. Has been exposed to a live vaccine within 6 weeks of screening or is expected to need/receive a live vaccine during the course of the study. Participants must not have received a Bacillus Calmette-Guerin (BCG) vaccination within 52 weeks of screening.