Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06846281 | Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis. | PHASE3 | RECRUITING | 360 | — | — | Jul 23, 2025 | Jun 24, 2031 | Jun 1, 2026 | 106 | United States, Argentina +17 |
| NCT05147220 | Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) | PHASE3 | ACTIVE NOT_RECRUITING | 1,000 | — | — | Dec 16, 2021 | Oct 30, 2030 | May 29, 2026 | 199 | United States, Argentina +32 |
| NCT05156281 | Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) | PHASE3 | ACTIVE NOT_RECRUITING | 1,007 | — | — | Dec 13, 2021 | Oct 30, 2030 | May 29, 2026 | 223 | United States, Argentina +25 |
Number of new/enlarging T2 lesions per year on MRI at month 24 (relative to baseline)
ARR is the average number of confirmed MS relapses in a year
| Arm | Type | Description |
|---|---|---|
| Remibrutinib Core | EXPERIMENTAL | Remibrutinib tablet taken orally |
| Ocrelizumab Core | ACTIVE_COMPARATOR | Ocrelizumab at standard dose and route of administration (i.v. or s.c) per label |
| Remibrutinib Extension | EXPERIMENTAL | Remibrutinib tablet taken orally |
| Remibrutinib Extension (Ocrelizumab in Core) | EXPERIMENTAL | Remibrutinib tablet taken orally |
| Remibrutinib - Core | EXPERIMENTAL | Remibrutinib tablet and matching placebo of teriflunomide capsule |
| Teriflunomide - Core | ACTIVE_COMPARATOR | Teriflunomide capsule and matching placebo remibrutinib tablet |
| Remibrutinib - Extension | EXPERIMENTAL | Participants on remibrutinib in Core will continue on remibrutinib tablet |
| Remibrutinib - Extension (on teriflunomide in Core) | EXPERIMENTAL | Participants on teriflunomide in Core will switch to remibrutinib tablet |
| Name | Type | Description |
|---|---|---|
| Remibrutinib oral treatment | DRUG | Remibrutinib tablet taken daily |
| Ocrelizumab | DRUG | Ocrelizumab 600mg infusion or 920mg injection |
| Remibrutinib | DRUG | tablet taken orally |
| Teriflunomide | DRUG | capsule taken orally |
Key Inclusion Criteria: * Male or female aged 40 to 70 years (inclusive) * Diagnosis of RMS according to the 2017 McDonald diagnostic criteria * Treated with ocrelizumab according to routine clinical practice and at standard dose * Neurologically stable within 30 days * Suitable to be switched to r...