Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Orelabrutinib · 2 trials · 2 indications
* Expanded disability status scale (EDSS) score increase ≥ 1.0 point from baseline when the baseline score is ≤ 5.0, or ≥ 0.5 points from baseline when the baseline score is \> 5.0, OR * ≥ 20% increase in the Timed 25-Foot Walk Test (T25FWT), OR * ≥ 20% increase in the 9-hole Peg Test (9HPT)
Expanded disability status scale (EDSS) score increase ≥ 1.0 point from baseline when the baseline score is ≤ 5.0, or ≥ 0.5 points from baseline when the baseline score is \> 5.0
| Arm | Type | Description |
|---|---|---|
| Orelabrutinib Group | EXPERIMENTAL | - |
| Placebo Group | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Orelabrutinib | DRUG | Orally |
| Placebo | DRUG | Orally |
Inclusion Criteria: * 18 to 60 years of age, inclusive * Diagnosed with Primary Progressive MS (PPMS) according to 2017 McDonald criteria * Participant must have documented evidence of disability progression observed during the 24 months before screening. * Expanded disability status scale (EDSS) s...