Clinical Trial Alert: Phase 3 Study of Brepocitinib in Adults with Dermatomyositis

Researchers at Priovant Therapeutics are seeking adults with dermatomyositis to participate in a phase 3 clinical trial (VALOR) to evaluate the safety and effectiveness of the investigational therapy brepocitinib to treat the condition. Brepocitinib is designed to block the part of the immune system involved in causing the inflammation seen in dermatomyositis. The current study is testing the ability of brepocitinib treatment to improve the visible skin changes and muscle weakness experienced by people with dermatomyositis.

This is a phase 3, double-blinded, placebo-controlled study. This means that participants will be randomly assigned to receive the drug or an inactive placebo control, and no one will know which participants received the drug. The duration of the study for participants will be up to 15 months for screening and treatment, up to 13 months for an optional open-label extension, and one additional month for follow-up. Participants will be required to attend up to 12 study visits (every 4-6 weeks) during screening and treatment, up to 5 visits if participating in the open-label extension, and one visit during the follow-up.

Participants will receive brepocitinib or a placebo control orally (by mouth). The effects of the drug may be evaluated using a number of tests and procedures including but not limited to: a medication review, health checks, manual muscle testing, skin checks, questions about symptoms, vital signs (such as blood pressure, heart rate, height and weight), blood and urine testing, and heart activity (electrocardiogram/EKG). Some participants may also need a CT or PET-CT scan, lung function testing, a chest x-ray, skin photos, and/or a pregnancy test.

To be eligible, individuals must meet the following inclusion criteria:

• A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies
• Adult dermatomyositis patient (18-75 years old)
• Active muscle and skin disease at screening and baseline
• Prior therapy OR current therapy with corticosteroids, hydroxychloroquine, and/or one non-steroid immunosuppressant
• Weight > 40 kg to < 130 kg, and with a body mass index (BMI) < 40 kg/m2

Individuals may not be eligible to participate if they are affected by another illness or receiving another treatment that might interfere with the ability to undergo safe testing.

Please visit this link for the full listing of inclusion and exclusion criteria.

Travel support is available for eligible participants.

To learn more about the study or inquire about participation, please visit the study website or contact the Patient Evaluation Manager Taryn Smith by email: patientsupport@priovanttx.com.