Relapsing Forms of Multiple SclerosisPhase 3VOYAGENCT07483632
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)
A Phase 3 study testing Diroximel Fumarate, Dimethyl Fumarate and Fingolimod in people with Relapsing Forms of Multiple Sclerosis, run by Biogen.
Trial summary
In this study, researchers will learn more about the study drugs diroximel fumarate (DRF) and dimethyl fumarate (DMF) in children with MS who may be experiencing relapses. Participants will be divided into 2 groups based on their weight: Group A will include children who weigh 40 kilograms (kg) or less. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Relapsing Forms of Multiple Sclerosis
- What is being tested?
- Diroximel Fumarate, Dimethyl Fumarate and Fingolimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 185 participants
- Where
- No sites listed yet
- Study dates
- 16 Nov 2026to 19 Jun 2035
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Treatment Period:
- Must have a diagnosis of pediatric MS (as defined by the revised consensus definition of pediatric MS).
- Must have an Expanded Disability Status Scale (EDSS) score between 0 and 5.0, inclusive.
- Must have experienced at least 1 of the following conditions:
- greater than or equal to 1 relapse in the 12 months prior to the Baseline Visit (Day 1),
- greater than or equal to 2 relapses in the 24 months prior to the Baseline Visit (Day 1), or
Show all 10Show fewer
- evidence of gadolinium (Gd)-enhancing lesions of the brain on magnetic resonance imaging (MRI) within 6 months prior to the Baseline Visit (Day 1).
- Participants must be neurologically stable with no evidence of relapse within 30 days prior to the Baseline Visit (Day 1).
- Open-Label Extension Period:
- Participants who completed the study treatment in Cohorts A or B through the Week 96 Visit.
Who cannot join
- Treatment Period:
- History of progressive MS.
- History of disorders mimicking MS, such as other demyelinating disorders (e.g., acute disseminated encephalomyelitis and neuromyelitis optical spectrum disorder), systemic autoimmune disorders (e.g., Sjögren's disease and lupus erythematosus), metabolic disorders (e.g., dystrophies), and infectious disorders.
- History of severe allergic or anaphylactic reactions or any allergic reactions that in the opinion of the Investigator are likely to be exacerbated by any component of the study treatment.
- History of, or ongoing, malignant disease, including solid tumors, skin malignancies, and hematologic malignancies.
- History of gastrointestinal (GI) surgery (except appendectomy or cholecystectomy that occurred more than 6 months prior to the Screening Visit), inflammatory bowel disease (Crohn's disease, ulcerative colitis), or another clinically significant and active GI condition at the Investigator's discretion.
Show all 13Show fewer
- Known hypersensitivity to fumaric acid derivatives or any excipients of DRF or DMF.
- Diagnosis of macular edema prior to randomization.
- Open-Label Extension Period:
- Any significant changes in medical history occurring after enrollment in the Treatment Period, including laboratory test abnormalities or current clinically significant conditions that, in the opinion of the Investigator, would have excluded the participant's participation in the Treatment Period. The Investigator must reassess the participant's medical fitness for participation and consider any factors that would preclude treatment.
- Participants who discontinued study treatment due to tolerability issues.
- Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the participant unsuitable for participation in the OLE Period.
- NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Global Biogen Clinical Trial Center contact
About this study
Official title: A Phase 3 Study With an Open-Label Extension in Pediatric Participants to Evaluate the Safety, Efficacy, and Pharmacokinetics of Diroximel Fumarate and Dimethyl Fumarate for the Treatment of Relapsing Forms of Multiple Sclerosis
In this study, researchers will learn more about the study drugs diroximel fumarate (DRF) and dimethyl fumarate (DMF) in children with MS who may be experiencing relapses.
Participants will be divided into 2 groups based on their weight:
Read more
- Group A will include children who weigh 40 kilograms (kg) or less. They will receive DRF in both Part 1 and Part 2 of the study.
- Group B will include children who weigh more than 40 kg. They will be randomly assigned to receive DRF, DMF, or fingolimod. Fingolimod is a drug already used to treat MS in adults. In Part 2, they will receive DRF.
This is a 2-part study. Part 1 treatment will last 96 weeks. Participants who complete Part 1 may move to Part 2. Part 2 is an extension period. Treatment will last another 96 weeks and will help researchers learn about the long-term safety and effects of treatment.
The main goal of the study is to learn about the safety of DRF and DMF and compare their effect on relapses and brain lesions with fingolimod.
The main questions researchers want to answer are:
- How many participants have adverse events and serious adverse events?
- How often do participants relapse after treatment with DRF and DMF compared to fingolimod?
Researchers will take brain imaging scans to check for any new areas of brain inflammation and compare the brain lesions before and after treatment.
Researchers will also measure the amount of drug in the blood to understand how the body processes it. To check safety, they will monitor participants' growth and development, and compare changes in heart tests, vital signs, and lab tests. They will also use rating scales to monitor depression symptoms.
The study will be done as follows:
Part 1 (Treatment Period)
- After screening, participants will join Part 1 and be divided into 2 groups based on their weight.
- Participants in Group A will receive DRF.
- Participants in Group B will be randomly assigned to receive either DRF, DMF, or fingolimod.
- Neither the researchers nor the participants will know which drug or dose the participants will receive in Group B. Participants in Group B will also receive a placebo so they do not know which drug is being given. A placebo looks like a study drug but contains no real medicine.
- All study drugs will be taken by mouth, once or twice a day. Participants who take DRF or DMF will start with a lower dose during the 1st week, then move to a standard dose.
- Treatment in Part 1 will last for 96 weeks. Participants will have up to 11 study visits and 7 phone calls.
- Participants who do not move onto Part 2 will also have a safety follow-up period of 4 to 8 weeks. This will include 1 study visit and 1 phone call.
- The total length of Part 1, including the screening, treatment, and follow-up, will be up to 108 weeks.
Part 2 (Extension Period)
- Participants who complete Part 1 can move on to Part 2 of the study.
- All participants in Part 2 will receive DRF by mouth for 96 weeks.
- Participants will have up to 10 more study visits and 1 telephone call during treatment.
- They will also have a 4-week safety follow-up, including 1 study visit and 1 phone call.
- The total length of Part 2 will be up to 100 weeks.
Read the detailed description
The primary objectives of this study are to evaluate the safety, tolerability of diroximel fumarate (DRF), the noninferiority of the clinical efficacy of monomethyl fumarate (MMF) (pooled DRF and dimethyl fumarate [DMF] treatment) compared to that of fingolimod and long-term safety and tolerability of DRF in participants who completed Week 96 of the Treatment Period. The secondary objectives of this study are to characterize the pharmacokinetic (PK) profile of DRF metabolites (MMF and 2-hydroxyethyl succinimide [HES]), additional safety and tolerability of DRF, noninferiority of the radiological efficacy of MMF (pooled DRF and DMF treatment) compared to that of fingolimod, and to further describe the safety and long-term multiple sclerosis (MS) outcomes of DRF in participants who completed Week 96 of the Treatment Period.
- Conditions
- Relapsing Forms of Multiple Sclerosis
- Being tested
- Diroximel Fumarate, Dimethyl Fumarate, Fingolimod, Placebo matching DRF, Placebo matching DMF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diroximel FumarateDrug
Also called Vumerity, BIIB098, ALK8700
Oral capsule
Dimethyl FumarateDrug
Also called Tecfidera, BG00012
Oral capsule
FingolimodDrug
Also called Gilenya
Oral capsule
Placebo matching DRFDrug
Oral capsule
Placebo matching DMFDrug
Oral capsule
Placebo matching fingolimodDrug
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| TP Cohort A | Experimental | Participants weighing ≤ 40 kilograms (kg) will receive DRF 231 milligrams (mg) orally, once daily (QD) (starting dose) on Days 1 to 7 followed by DRF 231 mg orally, BID (twice daily) (maintenance dose) on Day 8 through Week 96. Receives: Drug: Diroximel Fumarate |
| TP Cohort B: Sub-cohort 1: DRF | Experimental | Participants weighing >40 kg will receive DRF/placebo matching fingolimod 231 mg orally, BID (starting dose) on Days 1 to 7 followed by DRF 462 mg orally, BID (maintenance dose) on Day 8 through Week 96. Receives: Drug: Diroximel Fumarate; Drug: Placebo matching fingolimod |
| TP Cohort B: Sub-cohort 1: Fingolimod | Experimental | Participants weighing >40 kg will receive Fingolimod 0.5 mg orally, QD followed by placebo matching DRF 231 mg (starting dose) orally, BID on Days 1 to 7 followed by placebo matching DRF 462 mg (maintenance dose) orally, BID on Day 8 through Week 96. Receives: Drug: Fingolimod; Drug: Placebo matching DRF |
| TP Cohort B: Sub-cohort 2: DMF | Experimental | Participants weighing >40 kg will receive DMF/placebo matching fingolimod 120 mg (starting dose) orally, BID on Days 1 to 7 followed by DMF 240 mg (maintenance dose) orally BID, on Day 8 through Week 96. Receives: Drug: Dimethyl Fumarate; Drug: Placebo matching fingolimod |
| TP Cohort B: Sub-cohort 2: Fingolimod | Experimental | Participants weighing >40 kg will receive Fingolimod 0.5 mg oral QD followed by placebo matching DMF 120 mg (starting dose) orally, BID on Days 1 to 7 followed by placebo matching DMF 240 mg (maintenance dose) orally, BID through Week 96. Receives: Drug: Fingolimod; Drug: Placebo matching DMF |
| Open-label Extension (OLE) Period: Participants from Cohort A | Experimental | Participants from Cohort A weighing ≤ 40 kg will receive DRF 231 mg orally, BID and participants weighing >40 kg will receive DRF 462 mg orally, BID up to 192 weeks. Receives: Drug: Diroximel Fumarate |
| OLE Period: Participants from Cohort B | Experimental | Participants from Cohort B will receive DRF 231 mg orally, BID for 7 days, followed by the maintenance dose of DRF 462 mg orally, BID up to 192 weeks. Receives: Drug: Diroximel Fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Secondary outcomes (25)
TP Cohorts A and B: Maximum Observed Concentration at Steady State (Cmax,ss) of Monomethyl Fumarate (MMF)
Measured: Predose and at multiple timepoints post dose up to Week 96
TP Cohorts A and B: Minimum Observed Concentration at Steady State (Cmin,ss) of MMF
Measured: Predose and at multiple timepoints post dose up to Week 96
TP Cohorts A and B: Cmax,ss of 2-Hydroxyethyl Succinimide (HES)
Measured: Predose and at multiple timepoints post dose up to Week 96
TP Cohorts A and B: Cmin,ss of HES
Measured: Predose and at multiple timepoints post dose up to Week 96
TP Cohorts A, B and OLE Period: Number of Participants with Potentially Clinically Serious (PCS) Change from Baseline in Vital Sign Parameters
Measured: Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196
TP Cohorts A, B and OLE Period: Number of Participants With Change From Baseline in Clinically Relevant Electrocardiogram (ECG) Abnormalities
Measured: Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196
TP Cohorts A, B and OLE Period: Number of Participants with PCS Change from Baseline in Clinical Laboratory Parameters
Measured: Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196
TP Cohorts A, B and OLE Period: Change From Baseline in Height
Measured: Cohorts A and B: Baseline up to Week 104, OLE: Baseline (Week 96) up to Week 196
TP Cohorts A, B and OLE Period: Change From Baseline in Weight
Measured: Cohorts A and B: Baseline up to Week 104, OLE: Baseline (Week 96) up to Week 196
TP Cohorts A, B and OLE Period: Change From Baseline in Tanner Score
Assessment of Tanner stage will be performed by a healthcare professional experienced with this assessment. Tanner score ranges from Stage 1 (childhood) to Stage 5 (full physical maturity). Information regarding Tanner staging will be collected for all male participants with bone age < 16 years and for female participants who are premenarche and have a bone age of < 16 years and will be stopped once the participant's bone age reaches ≥ 16 years or once the participant is postmenarche.
Measured: Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196
TP Cohorts A, B and OLE Period: Change From Baseline in Bone Age
Measured: Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196
TP Cohorts A, B and OLE Period: Number of Participants with Change From Baseline in Endocrine Tests
Endocrine parameters to be tested will include insulin-like growth factor 1, and insulin-like growth factor binding protein for both females and males; follicle stimulating hormone (FSH), luteinizing hormone (LH), and estradiol (E-2) for females; and testosterone, FSH, and LH for males. All endocrine tests will stop being performed once the participant has reached a bone age of ≥ 16 years or the participant is postmenarche.
Measured: Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196
TP Cohorts A, B and OLE Period: Change From Baseline in Depression Monitored Using the Children's Depression Rating Scale for Participants <18 Years or the Hamilton Rating Scale for Depression (HAMD-17) for Participants ≥18 Years
Measured: Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196
TP Cohorts A, B and OLE Period: Change From Baseline in Depression Monitored Using the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assesses whether participant experiences any of the following 1. completed suicide, 2. suicide attempt (response of "yes" on "actual attempt"), 3. preparatory acts toward imminent suicidal behavior ("yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), 4. any suicidal behavior or ideation, suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent"), 5. self-injurious behavior, no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior").
Measured: Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196
TP Cohort B: Change From Baseline in Annualized Rate of New/Newly Enlarging (N/NE) T2 Hyperintense Lesions Through Week 96
Measured: Baseline (Day 1) up to Week 96
TP Cohort B: Time to First Relapse
Measured: Baseline (Day 1) up to Week 96
TP Cohort B: Percentage of Participants Free of Relapse up to Week 96
Measured: Baseline (Day 1) up to Week 96
TP Cohort B and OLE Period: Change From Baseline in Expanded Disability Status Scale (EDSS) Score
The EDSS is a method of quantifying disability and monitoring changes in the level of disability over time. EDSS score ranges from 0 (normal neurological exam) to 10 (death from MS) with higher scores indicating more disability.
Measured: Cohort B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196
TP Cohort B: Change From Baseline in Number of N/NE T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans at Weeks 48 and 96
Measured: Baseline up to Weeks 48 and 96
TP Cohort B: Number of Gadolinium (Gd)-Enhancing Lesions on Brain MRI Scans at Baseline and at Weeks 48 and 96
Measured: At Baseline, Weeks 48 and 96
TP Cohort B: Number of Participants With T1 Hypointense Lesions at Week 96
Measured: At Week 96
TP Cohort B: Change From Baseline in Percentage of Participants Free of N/NE T2 Hyperintense Lesions on Brain MRI Scans at Weeks 24, 48, and 96
Measured: Baseline up to Weeks 24, 48, and 96
TP Cohort B: Change From Baseline in Percentage of Participants Free of New MRI Activity at Weeks 24, 48, and 96
Free of new MRI activity is defined as free of Gd-enhancing lesions and free of N/NE T2 MRI lesions on brain MRI scans.
Measured: Baseline up to Weeks 24, 48, and 96
TP Cohort B: Number of Participants With TEAEs, SAEs and AEs Leading to Treatment Discontinuation
Measured: From first dose of study drug up to end of follow-up (up to Week 104)
OLE Period: ARR at Weeks 144 and 192
Measured: At Weeks 144 and 192
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start16 Nov 2026 (estimated)
- Primary completion28 Jul 2034 (estimated)
- Study completion19 Jun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Forms of Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483632
- Sponsor's protocol ID
- 272MS304
- Other IDs
- 2023-509409-60, 2023
- Acronym
- VOYAGE
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study With an Open-Label Extension in Pediatric Participants to Evaluate the Safety, Efficacy, and Pharmacokinetics of Diroximel Fumarate and Dimethyl Fumarate for the Treatment of Relapsing Forms of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07483632
- Acronym / sponsor ID
- VOYAGE / 272MS304
- Conditions
- Relapsing Forms of Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2026 (estimated)
- Primary completion
- 28 Jul 2034 (estimated)
- Study completion
- 19 Jun 2035 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, researchers will learn more about the study drugs diroximel fumarate (DRF) and dimethyl fumarate (DMF) in children with MS who may be experiencing relapses.
Participants will be divided into 2 groups based on their weight:
- Group A will include children who weigh 40 kilograms (kg) or less. They will receive DRF in both Part 1 and Part 2 of the study.
- Group B will include children who weigh more than 40 kg. They will be randomly assigned to receive DRF, DMF, or fingolimod. Fingolimod is a drug already used to treat MS in adults. In Part 2, they will receive DRF.
This is a 2-part study. Part 1 treatment will last 96 weeks. Participants who complete Part 1 may move to Part 2. Part 2 is an extension period. Treatment will last another 96 weeks and will help researchers learn about the long-term safety and effects of treatment.
The main goal of the study is to learn about the safety of DRF and DMF and compare their effect on relapses and brain lesions with fingolimod.
The main questions researchers want to answer are:
- How many participants have adverse events and serious adverse events?
- How often do participants relapse after treatment with DRF and DMF compared to fingolimod?
Researchers will take brain imaging scans to check for any new areas of brain inflammation and compare the brain lesions before and after treatment.
Researchers will also measure the amount of drug in the blood to understand how the body processes it. To check safety, they will monitor participants' growth and development, and compare changes in heart tests, vital signs, and lab tests. They will also use rating scales to monitor depression symptoms.
The study will be done as follows:
Part 1 (Treatment Period)
- After screening, participants will join Part 1 and be divided into 2 groups based on their weight.
- Participants in Group A will receive DRF.
- Participants in Group B will be randomly assigned to receive either DRF, DMF, or fingolimod.
- Neither the researchers nor the participants will know which drug or dose the participants will receive in Group B. Participants in Group B will also receive a placebo so they do not know which drug is being given. A placebo looks like a study drug but contains no real medicine.
- All study drugs will be taken by mouth, once or twice a day. Participants who take DRF or DMF will start with a lower dose during the 1st week, then move to a standard dose.
- Treatment in Part 1 will last for 96 weeks. Participants will have up to 11 study visits and 7 phone calls.
- Participants who do not move onto Part 2 will also have a safety follow-up period of 4 to 8 weeks. This will include 1 study visit and 1 phone call.
- The total length of Part 1, including the screening, treatment, and follow-up, will be up to 108 weeks.
Part 2 (Extension Period)
- Participants who complete Part 1 can move on to Part 2 of the study.
- All participants in Part 2 will receive DRF by mouth for 96 weeks.
- Participants will have up to 10 more study visits and 1 telephone call during treatment.
- They will also have a 4-week safety follow-up, including 1 study visit and 1 phone call.
- The total length of Part 2 will be up to 100 weeks.
Detailed description
The primary objectives of this study are to evaluate the safety, tolerability of diroximel fumarate (DRF), the noninferiority of the clinical efficacy of monomethyl fumarate (MMF) (pooled DRF and dimethyl fumarate [DMF] treatment) compared to that of fingolimod and long-term safety and tolerability of DRF in participants who completed Week 96 of the Treatment Period. The secondary objectives of this study are to characterize the pharmacokinetic (PK) profile of DRF metabolites (MMF and 2-hydroxyethyl succinimide [HES]), additional safety and tolerability of DRF, noninferiority of the radiological efficacy of MMF (pooled DRF and DMF treatment) compared to that of fingolimod, and to further describe the safety and long-term multiple sclerosis (MS) outcomes of DRF in participants who completed Week 96 of the Treatment Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| TP Cohort A | Experimental | Drug: Diroximel FumarateParticipants weighing ≤ 40 kilograms (kg) will receive DRF 231 milligrams (mg) orally, once daily (QD) (starting dose) on Days 1 to 7 followed by DRF 231 mg orally, BID (twice daily) (maintenance dose) on Day 8 through Week 96. |
| TP Cohort B: Sub-cohort 1: DRF | Experimental | Drug: Diroximel Fumarate, Drug: Placebo matching fingolimodParticipants weighing >40 kg will receive DRF/placebo matching fingolimod 231 mg orally, BID (starting dose) on Days 1 to 7 followed by DRF 462 mg orally, BID (maintenance dose) on Day 8 through Week 96. |
| TP Cohort B: Sub-cohort 1: Fingolimod | Experimental | Drug: Fingolimod, Drug: Placebo matching DRFParticipants weighing >40 kg will receive Fingolimod 0.5 mg orally, QD followed by placebo matching DRF 231 mg (starting dose) orally, BID on Days 1 to 7 followed by placebo matching DRF 462 mg (maintenance dose) orally, BID on Day 8 through Week 96. |
| TP Cohort B: Sub-cohort 2: DMF | Experimental | Drug: Dimethyl Fumarate, Drug: Placebo matching fingolimodParticipants weighing >40 kg will receive DMF/placebo matching fingolimod 120 mg (starting dose) orally, BID on Days 1 to 7 followed by DMF 240 mg (maintenance dose) orally BID, on Day 8 through Week 96. |
| TP Cohort B: Sub-cohort 2: Fingolimod | Experimental | Drug: Fingolimod, Drug: Placebo matching DMFParticipants weighing >40 kg will receive Fingolimod 0.5 mg oral QD followed by placebo matching DMF 120 mg (starting dose) orally, BID on Days 1 to 7 followed by placebo matching DMF 240 mg (maintenance dose) orally, BID through Week 96. |
| Open-label Extension (OLE) Period: Participants from Cohort A | Experimental | Drug: Diroximel FumarateParticipants from Cohort A weighing ≤ 40 kg will receive DRF 231 mg orally, BID and participants weighing >40 kg will receive DRF 462 mg orally, BID up to 192 weeks. |
| OLE Period: Participants from Cohort B | Experimental | Drug: Diroximel FumarateParticipants from Cohort B will receive DRF 231 mg orally, BID for 7 days, followed by the maintenance dose of DRF 462 mg orally, BID up to 192 weeks. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Must have a diagnosis of pediatric MS (as defined by the revised consensus definition of pediatric MS).
- Must have an Expanded Disability Status Scale (EDSS) score between 0 and 5.0, inclusive.
- Must have experienced at least 1 of the following conditions:
- Participants must be neurologically stable with no evidence of relapse within 30 days prior to the Baseline Visit (Day 1).
- Participants who completed the study treatment in Cohorts A or B through the Week 96 Visit.
Key exclusion criteria (13 listed)
- History of progressive MS.
- History of disorders mimicking MS, such as other demyelinating disorders (e.g., acute disseminated encephalomyelitis and neuromyelitis optical spectrum disorder), systemic autoimmune disorders (e.g., Sjögren's disease and lupus erythematosus), metabolic disorders (e.g., dystrophies), and infectious disorders.
- History of severe allergic or anaphylactic reactions or any allergic reactions that in the opinion of the Investigator are likely to be exacerbated by any component of the study treatment.
- History of, or ongoing, malignant disease, including solid tumors, skin malignancies, and hematologic malignancies.
- History of gastrointestinal (GI) surgery (except appendectomy or cholecystectomy that occurred more than 6 months prior to the Screening Visit), inflammatory bowel disease (Crohn's disease, ulcerative colitis), or another clinically significant and active GI condition at the Investigator's discretion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diroximel FumarateAlso: Vumerity, BIIB098, ALK8700Oral capsule | Drug | OLE Period: Participants from Cohort B, Open-label Extension (OLE) Period: Participants from Cohort A, TP Cohort A, TP Cohort B: Sub-cohort 1: DRF |
| Dimethyl FumarateAlso: Tecfidera, BG00012Oral capsule | Drug | TP Cohort B: Sub-cohort 2: DMF |
| FingolimodAlso: GilenyaOral capsule | Drug | TP Cohort B: Sub-cohort 1: Fingolimod, TP Cohort B: Sub-cohort 2: Fingolimod |
| Placebo matching DRFOral capsule | Drug | TP Cohort B: Sub-cohort 1: Fingolimod |
| Placebo matching DMFOral capsule | Drug | TP Cohort B: Sub-cohort 2: Fingolimod |
| Placebo matching fingolimodOral capsule | Drug | TP Cohort B: Sub-cohort 1: DRF, TP Cohort B: Sub-cohort 2: DMF |
Primary outcome
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
Time frame: 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
Time frame: Baseline (Day 1) up to Week 96
25 secondary outcomes
TP Cohorts A and B: Maximum Observed Concentration at Steady State (Cmax,ss) of Monomethyl Fumarate (MMF)
Time frame: Predose and at multiple timepoints post dose up to Week 96
TP Cohorts A and B: Minimum Observed Concentration at Steady State (Cmin,ss) of MMF
Time frame: Predose and at multiple timepoints post dose up to Week 96
TP Cohorts A and B: Cmax,ss of 2-Hydroxyethyl Succinimide (HES)
Time frame: Predose and at multiple timepoints post dose up to Week 96
TP Cohorts A and B: Cmin,ss of HES
Time frame: Predose and at multiple timepoints post dose up to Week 96
TP Cohorts A, B and OLE Period: Number of Participants with Potentially Clinically Serious (PCS) Change from Baseline in Vital Sign Parameters
Time frame: Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196
TP Cohorts A, B and OLE Period: Number of Participants With Change From Baseline in Clinically Relevant Electrocardiogram (ECG) Abnormalities
Time frame: Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196
TP Cohorts A, B and OLE Period: Number of Participants with PCS Change from Baseline in Clinical Laboratory Parameters
Time frame: Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196
TP Cohorts A, B and OLE Period: Change From Baseline in Height
Time frame: Cohorts A and B: Baseline up to Week 104, OLE: Baseline (Week 96) up to Week 196
TP Cohorts A, B and OLE Period: Change From Baseline in Weight
Time frame: Cohorts A and B: Baseline up to Week 104, OLE: Baseline (Week 96) up to Week 196
TP Cohorts A, B and OLE Period: Change From Baseline in Tanner Score
Time frame: Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196
TP Cohorts A, B and OLE Period: Change From Baseline in Bone Age
Time frame: Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196
TP Cohorts A, B and OLE Period: Number of Participants with Change From Baseline in Endocrine Tests
Time frame: Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196
TP Cohorts A, B and OLE Period: Change From Baseline in Depression Monitored Using the Children's Depression Rating Scale for Participants <18 Years or the Hamilton Rating Scale for Depression (HAMD-17) for Participants ≥18 Years
Time frame: Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196
TP Cohorts A, B and OLE Period: Change From Baseline in Depression Monitored Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Cohorts A and B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196
TP Cohort B: Change From Baseline in Annualized Rate of New/Newly Enlarging (N/NE) T2 Hyperintense Lesions Through Week 96
Time frame: Baseline (Day 1) up to Week 96
TP Cohort B: Time to First Relapse
Time frame: Baseline (Day 1) up to Week 96
TP Cohort B: Percentage of Participants Free of Relapse up to Week 96
Time frame: Baseline (Day 1) up to Week 96
TP Cohort B and OLE Period: Change From Baseline in Expanded Disability Status Scale (EDSS) Score
Time frame: Cohort B: Baseline up to Week 96, OLE: Baseline (Week 96) up to Week 196
TP Cohort B: Change From Baseline in Number of N/NE T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans at Weeks 48 and 96
Time frame: Baseline up to Weeks 48 and 96
TP Cohort B: Number of Gadolinium (Gd)-Enhancing Lesions on Brain MRI Scans at Baseline and at Weeks 48 and 96
Time frame: At Baseline, Weeks 48 and 96
TP Cohort B: Number of Participants With T1 Hypointense Lesions at Week 96
Time frame: At Week 96
TP Cohort B: Change From Baseline in Percentage of Participants Free of N/NE T2 Hyperintense Lesions on Brain MRI Scans at Weeks 24, 48, and 96
Time frame: Baseline up to Weeks 24, 48, and 96
TP Cohort B: Change From Baseline in Percentage of Participants Free of New MRI Activity at Weeks 24, 48, and 96
Time frame: Baseline up to Weeks 24, 48, and 96
TP Cohort B: Number of Participants With TEAEs, SAEs and AEs Leading to Treatment Discontinuation
Time frame: From first dose of study drug up to end of follow-up (up to Week 104)
OLE Period: ARR at Weeks 144 and 192
Time frame: At Weeks 144 and 192
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Global Biogen Clinical Trial Center contact
Medical Director study director
Biogen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diroximel Fumarate, Dimethyl Fumarate and Fingolimod in people with Relapsing Forms of Multiple Sclerosis, run by Biogen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US Biogen Clinical Trial Center (866-633-4636, clinicaltrials@biogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.