Trial · NCT07483632
A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)
NCT07483632, Phase 3, Not yet recruiting, Biogen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS). Trials, record NCT07483632. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07483632
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)
- NCT number
- NCT07483632
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 185 participants, estimated
- Lead sponsor
- Biogen
- Conditions
- Relapsing Forms of Multiple Sclerosis
- Interventions
- Diroximel Fumarate, Dimethyl Fumarate, Fingolimod, Placebo matching DRF, Placebo matching DMF, Placebo matching fingolimod
- First posted
- 2026-03-19
- Last updated
- 2026-03-19
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | TP Cohort A and OLE Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation | Cohort A: From first dose of study drug up to end of follow-up (up to Week 104), OLE: Baseline (Week 96) up to the end of OLE period (up to Week 196) | |
| Primary | TP Cohort B: Annualized Relapse Rate (ARR) Through Week 96 | Baseline (Day 1) up to Week 96 | |
| Secondary | TP Cohorts A and B: Maximum Observed Concentration at Steady State (Cmax,ss) of Monomethyl Fumarate (MMF) | Predose and at multiple timepoints post dose up to Week 96 | |
| Secondary | TP Cohorts A and B: Minimum Observed Concentration at Steady State (Cmin,ss) of MMF | Predose and at multiple timepoints post dose up to Week 96 | |
| Secondary | TP Cohorts A and B: Cmax,ss of 2-Hydroxyethyl Succinimide (HES) | Predose and at multiple timepoints post dose up to Week 96 | |
| Secondary | TP Cohorts A and B: Cmin,ss of HES | Predose and at multiple timepoints post dose up to Week 96 | |
| Secondary | TP Cohorts A, B and OLE Period: Number of Participants with Potentially Clinically Serious (PCS) Change from Baseline in Vital Sign Parameters | Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196 | |
| Secondary | TP Cohorts A, B and OLE Period: Number of Participants With Change From Baseline in Clinically Relevant Electrocardiogram (ECG) Abnormalities | Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196 | |
| Secondary | TP Cohorts A, B and OLE Period: Number of Participants with PCS Change from Baseline in Clinical Laboratory Parameters | Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196 | |
| Secondary | TP Cohorts A, B and OLE Period: Change From Baseline in Height | Cohorts A and B: Baseline up to Week 104, OLE: Baseline (Week 96) up to Week 196 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes0
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/NCT07483632
GET https://conductscience.org/api/trials/v1/NCT07483632/registered?page=2