A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults With Dermatomyositis
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults With Dermatomyositis
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.
Inclusion Criteria:
Exclusion Criteria:
Dermatomyositis with end-stage organ involvement
Dermatomyositis with irreversible muscle involvement
History of:
Overlap myositis/connective tissue disease (except for overlap with Sjögren's syndrome)
Participants at a risk of thrombosis or cardiovascular disease
Participants with a high risk for herpes zoster reactivation
Participants with active or recent infections
Caba, 1425, Argentina