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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 is a Phase 3 study that has completed, run by Celgene. The registered enrollment target is 63 participants.

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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.

Interventions

  • BIOLOGICAL Seasonal influenza vaccine
  • BIOLOGICAL Pneumococcal polysaccharide vaccine
  • BIOLOGICAL Tetanus, diphtheria, and acellular pertussis vaccine

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2021-11-11
Est. Completion 2023-11-15
Phase Phase 3

Sponsor

Celgene

308 total trials

What the Registry Record Tells You About NCT05028634

The ClinicalTrials.gov registry entry for NCT05028634 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 63 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 3 interventions - of which Seasonal influenza vaccine is the first listed.

NCT05028634 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.