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NCT04140305 · ClinicalTrials.gov registry record · Phase 3
Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)
A Phase 3 study, sponsored by Celgene.
- Terminated
- Registry status
- Phase 3
- Development phase
- 188
- Enrollment target
NCT04140305: Clinical Trial Phase 3 study, sponsored by Celgene.
NCT04140305 is a Phase 3 study that was terminated before completion, run by Celgene. The registered enrollment target is 188 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04140305, a Phase 3 study, was terminated before completion, sponsored by Celgene.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 188 participants
- Enrollment target
Study Summary
This is a multicenter, longitudinal, single-arm, open-label study to describe the change from baseline in cognitive processing speed, measured by the SDMT, in subjects with RMS treated with ozanimod HCl 1 mg at 3 years. All subjects will receive orally administered ozanimod HCl 1 mg. The primary efficacy endpoint is the proportion of subjects with a clinically meaningful increase in raw score of ≥ 4 points or 10% from baseline (improved). The treatment period is 36 months. For all subjects who finish the subject and for those who discontinue, there will be a 30-day (± 15 days) and a 90-day (± 10 days) Safety Follow-up Visit. There is no planned protocol extension following the end of the study. Approximately 250 subjects with RMS will be recruited for this study. Subjects with RMS will be enrolled in this study if they have received ≤ 1 DMT, have an EDSS ≤ 3.5, and have been diagnosed with RMS within 5 years of study entry. The Investigator will be responsible for the overall conduct of the study at the site, confirmation of subject eligibility, routine study subject clinical management including for MS relapses, and management of AEs.
Primary Outcome
Symbol Digit Modalities Test
Interventions
- DRUG RPC-1063
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2020-01-16 |
| Est. Completion | 2025-05-15 |
| Phase | Phase 3 |
Why NCT04140305 stopped before completion
NCT04140305 is an interventional study that assigns participants to a tested intervention. The registered 188 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 (76% lower).
The record links to 0 conditions, and to 1 intervention - of which RPC-1063 is the first listed.
NCT04140305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04140305 about?
NCT04140305 is a clinical study titled "Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)". This is a multicenter, longitudinal, single-arm, open-label study to describe the change from baseline in cognitive processing speed, measured by the SDMT, in subjects with RMS treated with ozanimod HCl 1 mg at 3 years. All subjects will receive orally administered ozanimod HCl 1 mg. The primary ef...
What is the current status of trial NCT04140305?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 188 participants. The study started on 2020-01-16. Estimated completion is 2025-05-15.
What interventions are being tested in trial NCT04140305?
The interventions under investigation include: RPC-1063 (DRUG).
Who is sponsoring clinical trial NCT04140305?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04140305's enrollment target sits among peer trials
188 1408th of 2000 higher than 591 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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