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Research summary · AI summary · not yet reviewedHuman studyPhase 3Published in a peer-reviewed journal
Human Study of Remibrutinib for Relapsing Multiple Sclerosis
In two Phase 3 clinical trials (REMODEL-1 and REMODEL-2) with 2007 participants, remibrutinib demonstrated a significantly lower annualised relapse rate (ARR) compared to teriflunomide. In REMODEL-1, the ARR was 0.073 for remibrutinib versus 0.112 for teriflunomide (RR 0.648, p=0.018). In REMODEL-2, the ARR rates were 0.080 vs 0.116 (RR 0.688, p=0.034).
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This plain-English summary was written by AI from a published abstract and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
- Human efficacy
- Demonstrated in people
- Mechanism
- Other
- Evidence strength
- Strong
- Outcome
- Positive
Why it matters
These results suggest remibrutinib could be an effective new oral treatment option for relapsing multiple sclerosis, offering a possible improvement over existing therapies.
What this does not prove
These trials are ongoing and not currently recruiting, meaning long-term effects and additional data on safety and efficacy are still pending.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 2007 · two trials (REMODEL-1 and REMODEL-2)
- Randomised
- Yes
- Controlled
- Yes
- Primary endpoint met
- Yes
- Relevant MS type
- RRMS
- Publication date
- 2026-10-23
- Evidence reviewed
- Abstract only
- Regulatory approval
- Not reported
- Research areas
- Other
- Biological target
- BTK
- Pathway
- Not reported
- Population
- Patients aged 18-55 years with relapsing multiple sclerosis, an Expanded Disability Status Scale score of 0-5·5, and evidence of recent disease activity
- Size of effect
- RR 0·648 [95% CI 0·453-0·927]; p=0·018 in REMODEL-1; RR 0·688 [0·487-0·972]; p=0·034 in REMODEL-2
- Secondary endpoints
- Not reported
- MRI endpoints
- Not reported
- Biomarkers
- Not reported
- Safety
- upper respiratory tract infection (132 [13·1%] with remibrutinib vs 137 [13·7%] with teriflunomide), nasopharyngitis (92 [9·1%] vs 123 [12·3%]), diarrhoea (84 [8·3%] vs 109 [10·9%]), alopecia (58 [5·8%] vs 135 [13·5%]), and fewer adverse events leading to treatment discontinuation with remibrutinib (31 [3·1%] versus teriflunomide (58 [5·8%]).
Original sources
- Primary evidenceRemibrutinib versus teriflunomide in relapsing multiple sclerosis (REMODEL-1 and REMODEL-2): two randomised, phase 3 trials. ↗DOI: 10.1016/s0140-6736(26)02058-1
Supporting passages (26)
study phaseMETHODS: REMODEL-1 and REMODEL-2 are two identical, randomised, double-blind, double-dummy, active comparator-controlled, parallel-group, event-driven, phase 3 trials conducted at 407 centres in 46 countries.
study designMETHODS: REMODEL-1 and REMODEL-2 are two identical, randomised, double-blind, double-dummy, active comparator-controlled, parallel-group, event-driven, phase 3 trials conducted at 407 centres in 46 countries.
subjectsWe assessed the efficacy and safety of remibrutinib in adult patients with relapsing multiple sclerosis.
speciesWe assessed the efficacy and safety of remibrutinib in adult patients with relapsing multiple sclerosis.
sample sizeFINDINGS: Between Dec 13, 2021, and Dec 30, 2025, 2632 patients were screened and 2007 patients were randomly assigned.
sample size basisFINDINGS: Between Dec 13, 2021, and Dec 30, 2025, 2632 patients were screened and 2007 patients were randomly assigned.
randomizedPatients, site investigators, and trial team were masked to treatment allocation.
controlledMETHODS: REMODEL-1 and REMODEL-2 are two identical, randomised, double-blind, double-dummy, active comparator-controlled, parallel-group, event-driven, phase 3 trials conducted at 407 centres in 46 countries.
primary endpoint metThe primary endpoint was annualised relapse rate (ARR), defined as the number of confirmed multiple sclerosis relapses per patient-year with up to 30 months of follow-up, and assessed in all randomly assigned patients.
research categoriesThese findings support remibrutinib as a potential new oral treatment option for relapsing multiple sclerosis.
relevant ms typesWe assessed the efficacy and safety of remibrutinib in adult patients with relapsing multiple sclerosis.
publication datePublication date: 2026-10-23
interventionPatients aged 18-55 years with relapsing multiple sclerosis, an Expanded Disability Status Scale score of 0-5·5, and evidence of recent disease activity were randomly assigned 1:1 to oral remibrutinib 100 mg twice daily or teriflunomide 14 mg once daily via interactive response technology.
comparatorPatients aged 18-55 years with relapsing multiple sclerosis, an Expanded Disability Status Scale score of 0-5·5, and evidence of recent disease activity were randomly assigned 1:1 to oral remibrutinib 100 mg twice daily or teriflunomide 14 mg once daily via interactive response technology.
primary endpointThe primary endpoint was annualised relapse rate (ARR), defined as the number of confirmed multiple sclerosis relapses per patient-year with up to 30 months of follow-up, and assessed in all randomly assigned patients.
follow upThe primary endpoint was annualised relapse rate (ARR), defined as the number of confirmed multiple sclerosis relapses per patient-year with up to 30 months of follow-up, and assessed in all randomly assigned patients.
findingsARR was significantly lower with remibrutinib than with teriflunomide: 0·073 versus 0·112 (rate ratio [RR] 0·648 [95% CI 0·453-0·927]; p=0·018) in REMODEL-1 and 0·080 versus 0·116 (RR 0·688 [0·487-0·972]; p=0·034) in REMODEL-2.
limitationsThese trials are registered with ClinicalTrials.gov (NCT05147220 and NCT05156281) and are ongoing, not recruiting.
mechanismsRemibrutinib is a highly selective, potent, covalent, CNS-penetrant, oral BTK inhibitor.
biological targetsRemibrutinib is a highly selective, potent, covalent, CNS-penetrant, oral BTK inhibitor.
populationPatients aged 18-55 years with relapsing multiple sclerosis, an Expanded Disability Status Scale score of 0-5·5, and evidence of recent disease activity were randomly assigned 1:1 to oral remibrutinib 100 mg twice daily or teriflunomide 14 mg once daily via interactive response technology.
outcomewhile maintaining a favourable safety profile.
effect size0·073 versus 0·112 (rate ratio [RR] 0·648 [95% CI 0·453-0·927]; p=0·018) in REMODEL-1 and 0·080 versus 0·116 (RR 0·688 [0·487-0·972]; p=0·034) in REMODEL-2.
safety signalsThe most common adverse events were upper respiratory tract infection (132 [13·1%] of 1006 with remibrutinib vs 137 [13·7%] of 1001 with teriflunomide), nasopharyngitis (92 [9·1%] vs 123 [12·3%]), diarrhoea (84 [8·3%] vs 109 [10·9%]), and alopecia (58 [5·8%] vs 135 [13·5%]).
human efficacyThese findings support remibrutinib as a potential new oral treatment option for relapsing multiple sclerosis.
peer reviewedPublication types: Journal Article
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