Safety and efficacy Phase 3 study of lenabasum in dermatomyositis
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis
IRAS ID
257629
Contact name
Hector Chinoy
Contact email
Sponsor organisation
Corbus Pharmaceuticals, Inc.
Eudract number
2018-003273-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Dermatomyositis (DM) is a severe autoimmune disease. The investigational drug, lenabasum, is a drug that binds on cannabinoid type 2 receptor (CB2) expressed mostly by activated immune cells. Binding of lenabasum to CB2 on activated immune cells triggers the well-described process of resolution of innate immune responses, potentially allowing physicians to reduce immunosuppressant treatment.
The aim of the study is to assess the safety and efficacy of lenabasum in a population of DM patients, with serious and systemic manifestations of the disease. The total subject duration for this study will be approximately 60 weeks and will include the following: a screening (up to 4 weeks), a 52-week-treatment period, and a safety follow up that will be conducted 4±1 weeks after the last study drug dose.
Subjects enrolled in this study will be allowed to continue their current treatment. Allowing subjects to continue treatment will also reduce the risk of disease flare precipitated by discontinuation of baseline medication to meet the entry criteria.
Subjects will be randomized to receive lenabasum 20 mg, lenabasum 5 mg, or placebo twice-daily (BID) in a 2:1:2 ratio. During the study, for subjects that show at least mild improvement compared to baseline for two consecutive visits (improvement demonstrated by a TIS score ≥ 20), the investigator will be allowed to recommend a reduction in subjects’ immunosuppressant treatment.
Approximately 150 male and female subjects ≥ 18 years of age with active dermatomyositis will participate in this study at approximately 60 investigational sites in North America, Europe and Asian Pacific regions.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
19/NW/0144
Date of REC Opinion
21 May 2019
REC opinion
Further Information Favourable Opinion