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NCT05028634 · ClinicalTrials.gov registry record · Phase 3
Safety Study to Evaluate Immune Response of Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Ozanimod Compared to Non-Pegylated Interferon (IFN)-β or No Disease Modifying Therapy
A Phase 3 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 3
- Development phase
- 63
- Enrollment target
NCT05028634: Completed Phase 3 study, sponsored by Celgene.
NCT05028634 is a Phase 3 study that has completed, run by Celgene. The registered enrollment target is 63 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05028634, a Phase 3 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 63 participants
- Enrollment target
Study Summary
This study is designed to provide data on the immune response and safety of administering vaccines to relapsing multiple sclerosis (RMS) participants taking ozanimod compared to controls taking interferon-beta's or receiving no disease modifying therapies (DMTs). The data of this study will support the labels for ozanimod in multiple sclerosis (MS) because the effect of ozanimod on the vaccination response of MS participants is of interest to participants and prescribers.
Primary Outcome
Serologic response to tetanus toxoid criteria are as follows - if pre vaccination antibody titer is ≤0.10 IU/mL, post-vaccination level ≥0.40 IU/mL; if pre-vaccination antibody titer is \>0.10 IU/mL and ≤2.7 IU/mL, at least a 4-fold increase in titer; if pre-vaccination antibody titer is\>2.7 IU/mL, at least a 2-fold increase in titer.
Interventions
- BIOLOGICAL Seasonal influenza vaccine
- BIOLOGICAL Pneumococcal polysaccharide vaccine
- BIOLOGICAL Tetanus, diphtheria, and acellular pertussis vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2021-11-11 |
| Est. Completion | 2023-11-15 |
| Phase | Phase 3 |
What the finished NCT05028634 record still lists
NCT05028634 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Seasonal influenza vaccine is the first listed.
NCT05028634 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05028634 about?
NCT05028634 is a clinical study titled "Safety Study to Evaluate Immune Response of Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Ozanimod Compared to Non-Pegylated Interferon (IFN)-β or No Disease Modifying Therapy". This study is designed to provide data on the immune response and safety of administering vaccines to relapsing multiple sclerosis (RMS) participants taking ozanimod compared to controls taking interferon-beta's or receiving no disease modifying therapies (DMTs). The data of this study will support ...
What is the current status of trial NCT05028634?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 63 participants. The study started on 2021-11-11. Estimated completion is 2023-11-15.
What interventions are being tested in trial NCT05028634?
The interventions under investigation include: Seasonal influenza vaccine (BIOLOGICAL), Pneumococcal polysaccharide vaccine (BIOLOGICAL), Tetanus, diphtheria, and acellular pertussis vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05028634?
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 NCT05028634's enrollment target sits among peer trials
63 1800th of 2000 higher than 199 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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