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NCT03232073 · ClinicalTrials.gov registry record · Phase 3
Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis
A Phase 3 study, sponsored by Actelion.
- Completed
- Registry status
- Phase 3
- Development phase
- 877
- Enrollment target
NCT03232073: Completed Phase 3 study, sponsored by Actelion.
NCT03232073 is a Phase 3 study that has completed, run by Actelion. The registered enrollment target is 877 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03232073, a Phase 3 study, has completed, sponsored by Actelion.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 877 participants
- Enrollment target
Study Summary
The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS). The AC-058B303 study is the long-term extension for the core study AC-058B301. The purpose of this long term extension of the core study AC-058B301 is to characterize the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with RMS.
Primary Outcome
ARR: number of confirmed relapses per patient-year. Relapse: new, worsening, or recurrent neurological symptoms that occurred at least 30 days after the onset of a preceding relapse, and that lasted at least 24 hours, in the absence of fever or infection. A confirmed relapse is identified when a patient's symptoms worsen as indicated by an increase in their Expanded Disability Status Scale (EDSS) or Functional Systems (FS) scores, consistent with previous clinically stable assessments. Specific
Interventions
- DRUG Ponesimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 877 participants |
| Start Date | 2017-07-05 |
| Est. Completion | 2024-01-16 |
| Phase | Phase 3 |
What the finished NCT03232073 record still lists
NCT03232073 is an interventional study that assigns participants to a tested intervention. The registered 877 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher).
The record links to 0 conditions, and to 1 intervention - of which Ponesimod is the first listed.
NCT03232073 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03232073 about?
NCT03232073 is a clinical study titled "Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis". The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS). The AC-058B303 study is the long-term extension for the core study AC-058B301. The purpose of this long term extension ...
What is the current status of trial NCT03232073?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 877 participants. The study started on 2017-07-05. Estimated completion is 2024-01-16.
What interventions are being tested in trial NCT03232073?
The interventions under investigation include: Ponesimod (DRUG).
Who is sponsoring clinical trial NCT03232073?
This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03232073's enrollment target sits among peer trials
877 371st of 2000 higher than 1,629 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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