Trial · NCT06408259
Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
NCT06408259, Phase 3, Recruiting, Bristol-Myers Squibb
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis. Trials, record NCT06408259. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06408259
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
- NCT number
- NCT06408259
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 194 participants, estimated
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- Ozanimod, Fingolimod, Placebo
- First posted
- 2024-05-10
- Last updated
- 2026-09-10
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized relapse rate (ARR) | Up to 2 years | |
| Secondary | Proportion of participants who did not have a confirmed relapse | At 12 and 24 months | |
| Secondary | Number of gadolinium enhancing (GdE) T1 lesions | At month 6 and month 12 | |
| Secondary | Number of new or newly enlarging hyperintense lesions on T2 magnetic resonance imaging (MRI) sequences | At 6, 12, 18, and 24 months | |
| Secondary | Incidence of treatment-emergent adverse events (TEAEs) over the treatment period and over the post-treatment follow-up period | Up to 87 months | |
| Secondary | Incidence of adverse event of special interests (AESIs) over the treatment period and over the post-treatment follow-up period | Up to 87 months | |
| Secondary | Adverse events (AEs) leading to discontinuation over the treatment period and over the post-treatment follow-up period | Up to 87 months | |
| Secondary | Steady state plasma concentrations of ozanimod | At day 90 | |
| Secondary | Steady state plasma concentrations of the primary active metabolite CC112273 | At day 90 | |
| Secondary | Change from baseline pharmacodynamics (PD) biomarkers of absolute lymphocyte count | At day 90 and throughout the study up to 24 months |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06408259
GET https://conductscience.org/api/trials/v1/NCT06408259/registered