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NCT03813160 · ClinicalTrials.gov registry record · Phase 3
Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis
A Phase 3 study, sponsored by Corbus Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 176
- Enrollment target
NCT03813160: Completed Phase 3 study, sponsored by Corbus Pharmaceuticals.
NCT03813160 is a Phase 3 study that has completed, run by Corbus Pharmaceuticals. The registered enrollment target is 176 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03813160, a Phase 3 study, has completed, sponsored by Corbus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 176 participants
- Enrollment target
Study 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.
Primary Outcome
TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.
Interventions
- DRUG Placebo
- DRUG Lenabasum 20 mg
- DRUG Lenabasum 5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2018-12-17 |
| Est. Completion | 2021-10-05 |
| Phase | Phase 3 |
What the finished NCT03813160 record still lists
NCT03813160 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03813160 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03813160 about?
NCT03813160 is a clinical study titled "Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis". 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 ...
What is the current status of trial NCT03813160?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 176 participants. The study started on 2018-12-17. Estimated completion is 2021-10-05.
What interventions are being tested in trial NCT03813160?
The interventions under investigation include: Placebo (DRUG), Lenabasum 20 mg (DRUG), Lenabasum 5 mg (DRUG).
Who is sponsoring clinical trial NCT03813160?
This trial is sponsored by Corbus Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03813160's enrollment target sits among peer trials
176 1438th of 2000 higher than 561 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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