Brepocitinib for Dermatomyositis
(VALOR Trial)
Trial Summary
What is the purpose of this trial?
This trial tests brepocitinib, a drug that blocks inflammation-causing proteins, in adults with dermatomyositis. The goal is to see if it improves symptoms like muscle weakness and skin rashes by reducing inflammation. Another similar drug has shown positive results in treating difficult cases of dermatomyositis.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants can have prior or current therapy with corticosteroids, hydroxychloroquine, and one non-steroid immunosuppressant, so you might be able to continue these.
What data supports the effectiveness of the drug Brepocitinib for treating dermatomyositis?
Brepocitinib is a JAK inhibitor, similar to tofacitinib and peficitinib, which have shown effectiveness in treating dermatomyositis, a condition where the immune system attacks the skin and muscles. These drugs have helped patients who did not respond to other treatments, suggesting that Brepocitinib might also be effective.12345
How is the drug Brepocitinib unique for treating dermatomyositis?
Brepocitinib is unique because it is a JAK inhibitor, similar to other drugs like tofacitinib and baricitinib, which have shown effectiveness in treating refractory dermatomyositis. This class of drugs works by blocking specific enzymes (Janus kinases) involved in the inflammatory process, offering a novel approach for patients who do not respond to standard treatments.23467
Research Team
Christina Crater, MD
Principal Investigator
Senior Director, Clinical Development
Noriko Iikuni, MD
Principal Investigator
VP, Clinical Development
Eligibility Criteria
Adults aged 18-75 with dermatomyositis, weighing between 40-130 kg and a BMI under 40. Participants must have active muscle and skin disease, may be on or have had corticosteroids or immunosuppressants, and meet specific diagnostic criteria. Excluded are those with recent cancers (with some exceptions), high thrombosis risk, severe infections, irreversible muscle damage from the disease, end-stage organ involvement, certain other diseases or conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive brepocitinib or placebo for 52 weeks in a double-blind manner
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may opt into continuation of brepocitinib treatment for an additional 52 weeks
Treatment Details
Interventions
- Brepocitinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Priovant Therapeutics, Inc.
Lead Sponsor