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NCT03398837 · ClinicalTrials.gov registry record · Phase 3
Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
A Phase 3 study, sponsored by Corbus Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 365
- Enrollment target
NCT03398837: Clinical Trial Phase 3 study, sponsored by Corbus Pharmaceuticals.
NCT03398837 is a Phase 3 study that was terminated before completion, run by Corbus Pharmaceuticals. The registered enrollment target is 365 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03398837, a Phase 3 study, was terminated before completion, sponsored by Corbus Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 365 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 diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks.
Primary Outcome
The ACR CRISS exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in mRSS, FVC % predicted, physician and patient global assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement.
Interventions
- OTHER Placebo oral capsule
- DRUG Lenabasum 20 mg
- DRUG Lenabasum 5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 365 participants |
| Start Date | 2017-12-18 |
| Est. Completion | 2020-12-21 |
| Phase | Phase 3 |
Why NCT03398837 stopped before completion
NCT03398837 is an interventional study that assigns participants to a tested intervention. The registered 365 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 (53% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo oral capsule is the first listed.
NCT03398837 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03398837 about?
NCT03398837 is a clinical study titled "Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis". This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Aust...
What is the current status of trial NCT03398837?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 365 participants. The study started on 2017-12-18. Estimated completion is 2020-12-21.
What interventions are being tested in trial NCT03398837?
The interventions under investigation include: Placebo oral capsule (OTHER), Lenabasum 20 mg (DRUG), Lenabasum 5 mg (DRUG).
Who is sponsoring clinical trial NCT03398837?
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 NCT03398837's enrollment target sits among peer trials
365 1001st of 2000 higher than 998 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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