Phase 3 Study to Investigate the Efficacy and Safety of Brepocitinib in Adults with Dermatomyositis
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults with Dermatomyositis
IRAS ID
1005694
Contact name
Clinical Trial Administrator
Contact email
Sponsor organisation
Priovant Therapeutics Inc.
Eudract number
2021-006043-95
Clinicaltrials.gov Identifier
Research summary
Dermatomyositis is a rare inflammatory disease characterised by muscle weakness and a distinctive skin rash. As the disease progresses, patients may become disabled by irreversible muscle damage.\nBrepocitinib is being developed for the treatment of patients with dermatomyositis. The purpose of this study is to determine how effective and how safe brepocitinib is in patients with dermatomyositis. \nParticipants will be randomised 1:1:1 to 1 of 3 intervention groups - either brepocitinib 30 mg, brepocitinib 15 mg, or placebo (dummy drug with no active medicine), which they will take by mouth daily for 52 weeks. This is a double-blind study which means that neither the patient nor the study staff will know which drug they are taking. \nApproximately 225 participants will take part in this study globally.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0236
Date of REC Opinion
16 Feb 2023
REC opinion
Further Information Favourable Opinion