At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 176 enrolled
Drug / intervention
Lenabasum 20 mg +2 moredrug
Likely dose
Lenabasum 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis
In Brief
A Phase 3 clinical trial evaluating Lenabasum 20 mg, Lenabasum 5 mg, and 1 other intervention for Dermatomyositis. Completed, enrolled 176 participants across 54 sites in 13 countries.
Detailed Summary
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of dermatomyositis. Approximately 150 subjects will be enrolled in this study at about 60 sites in North America, Europe, and Asia. The planned duration of double-blind treatment with study drug is up to 52 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDermatomyositis
CountriesBulgaria, Canada, Czechia, Germany, Hungary, Italy, Japan, Poland, South Korea, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartDec 2018
First PostedJan 2019
Primary CompletionMar 2021
Study CompletionOct 2021
TodayJul 2026
First PostedJan 23, 2019
Enrollment StartDec 17, 2018
Primary CompletionMar 31, 2021
Study CompletionOct 5, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.4 years ago
Interventions
Lenabasum 20 mgdrug
oral capsule
Lenabasum 5 mgdrug
oral capsule
Placebodrug
oral capsule