A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults with Dermatomyositis
1. To evaluate the efficacy of brepocitinib for the treatment of dermatomyositis based on time to use of rescue medication through 52 weeks of brepocitinib administration QD, in comparison to placebo. 2. To evaluate the efficacy of brepocitinib for the treatment of dermatomyositis based on MMT-8 after 52 weeks of brepocitinib administration QD, in comparison to placebo.
This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM). 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 have the option to continue therapy in a 52 week open-label extension phase where all participants will receive brepocitinib.More
An adult with diagnosis of dermatomyositis with active muscle and skin disease No end stage organ involvement and no overlap of myositis.connective tissue disease.
Inclusion Criteria: 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, hydroxychloroquine, and/or one non-steroid immunosuppressant Weight > 40 kg to < 130 kg, and with a body mass index (BMI) < 40 kg/m2. Exclusion Criteria: 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 and cardiovascular disease Participants with a high risk for herpes zoster reactivation Participants with active or recent infection
Barbara Davis Center
University of Colorado Hospital
Elena Weinstein, MD
Protocol Number: 22-2265
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