Table 1.
Bruton tyrosine kinase inhibitors in ongoing clinical trials for the treatment of multiple sclerosis
| Study | Phase | Setting | Treatment duration | Treatment groupsa |
|---|---|---|---|---|
| Evobrutinib | ||||
| NCT02975349 (ref. 185) | II | RRMS (n = 261) | 24–48 weeks | Evobrutinib (n = 154), dimethyl fumarate (n = 54), placebo (n = 53) |
| NCT04338061 | III | RRMS (n = 1,124) | ≤156 weeks | Evobrutinib, teriflunomide |
| NCT04338022 | III | RRMS (n = 1,124) | ≤156 weeks | Evobrutinib, teriflunomide |
| Tolebrutinib | ||||
| NCT03889639 (ref. 186) | IIb | RMS (n = 130) | 12 weeks | Tolebrutinib (n = 129) |
| NCT04458051 | III | PPMS (n = 990) | 24–48 months | Tolebrutinib (n = 660), placebo (n = 330) |
| NCT04411641 | III | Non-relapsing SPMS (n = 1,290) | 24–48 months | Tolebrutinib (n = 860), placebo (n = 430) |
| NCT04410991 | III | RMS (n = 900) | 18–36 months | Tolebrutinib (n = 450), teriflunomide (n = 450) |
| NCT04410978 | III | RMS (n = 900) | 18–36 months | Tolebrutinib (n = 450), teriflunomide (n = 450) |
| NCT04742400 | II | MS (n = 10) | ≥96 weeks | Tolebrutinib (n = 10) |
| NCT03996291 | II | RMS (n = 125) | 62 months | Tolebrutinib |
| Fenebrutinib | ||||
| NCT05119569 | II | RMS (n = 109) | 12 weeks | Fenebrutinib, placebo |
| NCT04586023 | III | RMS (n = 736) | 96 weeks | Fenebrutinib, teriflunomide |
| NCT04586010 | III | RMS (n = 736) | 96 weeks | Fenebrutinib, teriflunomide |
| NCT04544449 | III | PPMS (n = 946) | 120 weeks | Fenebrutinib, ocrelizumab |
| Remibrutinib | ||||
| NCT05147220 | III | RMS (n = 800) | ≤30 months | Remibrutinib (n = 400), teriflunomide (n = 400) |
| NCT05156281 | III | RMS (n = 800) | ≤30 months | Remibrutinib (n = 400), teriflunomide (n = 400) |
| Orelabrutinib | ||||
| NCT04711148 | II | RRMS (n = 160) | 120 weeks | Orelabrutinib (n = 120)b, placebo (n = 40) |
MS, multiple sclerosis; PPMS, primary progressive multiple sclerosis; RMS, relapsing multiple sclerosis; RRMS, relapsing-remitting multiple sclerosis; SPMS, secondary progressive multiple sclerosis. aFinal patient numbers are not yet available for some ongoing studies. bThree orelabrutinib dose groups (n = 40 each).