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)
← catalyst calendarNCT07483632 · readout in 2,899 d
Sponsored by Biogen (industry) · BIIB — their whole pipeline →.
Phase
Phase 3
Status
Not yet recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
185estimated
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-11-16 | estimated | When the study began enrolling |
| Primary completion | 2034-07-28 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2035-06-19 | estimated | The whole study's end, after follow-up |
| First posted | 2026-03-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Relapsing Forms of Multiple Sclerosis
Interventions
- Drug: Diroximel Fumarate — also filed as Vumerity, BIIB098, ALK8700
- Drug: Dimethyl Fumarate — also filed as Tecfidera, BG00012
- Drug: Fingolimod — also filed as Gilenya
- Drug: Placebo matching DRF
- Drug: Placebo matching DMF
- Drug: Placebo matching fingolimod
Primary outcomes
what the primary-completion date above is the date OFTP Cohort A and OLE Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation
measured 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)
TP Cohort B: Annualized Relapse Rate (ARR) Through Week 96
measured Baseline (Day 1) up to Week 96
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