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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 is a Phase 3 study that was terminated before completion, run by Celgene. The registered enrollment target is 188 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04140305
The ClinicalTrials.gov registry entry for NCT04140305 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 188 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RPC-1063 is the first listed.
NCT04140305 reports 0 study locations.
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.
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