Brepocitinib for Dermatomyositis
(VALOR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called brepocitinib for adults with dermatomyositis, a condition that causes muscle weakness and skin rashes. Researchers aim to determine if brepocitinib improves symptoms compared to a placebo (a pill with no active medicine). Participants will receive one of two doses of brepocitinib or a placebo for 52 weeks, with the option to continue with the actual medicine afterward. Ideal participants have active symptoms despite past or current treatments like steroids and no severe organ damage from dermatomyositis. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.
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.
Is there any evidence suggesting that brepocitinib is likely to be safe for humans?
Research has shown that brepocitinib, a type of medication, was tested for safety in earlier studies. In these studies, brepocitinib was generally well-tolerated, with most participants not experiencing serious problems. Reported side effects were usually mild to moderate, such as headaches, nausea, and some skin reactions, while serious side effects were rare.
Brepocitinib is now in a phase 3 trial, indicating that extensive safety information exists from earlier trials. This phase focuses more on the treatment's effectiveness, providing a solid understanding of its safety. Brepocitinib is also being tested for other conditions, offering additional safety data. Always consult a healthcare provider to understand what these findings mean for individual circumstances.12345Why do researchers think this study treatment might be promising for dermatomyositis?
Brepocitinib is unique because it targets the condition dermatomyositis with a fresh approach. Most treatments for dermatomyositis focus on suppressing the immune system broadly, but Brepocitinib works differently. It specifically inhibits Janus kinase (JAK) and tyrosine kinase 2 (TYK2), which are enzymes involved in the immune response. This targeted action could mean fewer side effects and more effective control of symptoms compared to traditional treatments. Researchers are excited about Brepocitinib because it has the potential to offer a more precise and effective treatment option for people with this challenging condition.
What evidence suggests that brepocitinib might be an effective treatment for dermatomyositis?
Research has shown that brepocitinib yields promising results for conditions like dermatomyositis, psoriasis, and psoriatic arthritis. One study found that participants taking 30 mg of brepocitinib daily experienced significantly better outcomes than those on a placebo. This trial will test different doses of brepocitinib, with some participants receiving Brepocitinib Dose Level 1 or Dose Level 2, while others receive a placebo. The drug blocks certain enzymes, TYK2 and JAK1, which play a role in inflammation. Although more research is needed specifically for dermatomyositis, these findings are encouraging.678910
Who Is on the Research Team?
Christina Crater, MD
Principal Investigator
Senior Director, Clinical Development
Noriko Iikuni, MD
Principal Investigator
VP, Clinical Development
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- Brepocitinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Priovant Therapeutics, Inc.
Lead Sponsor