Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ocrelizumab · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| ABP 692 | EXPERIMENTAL | Participants affected by relapsing-remitting multiple sclerosis (RRMS) will receive an initial dose of 300 mg ABP 692 intravenous (IV) infusion on Day 1, followed by a second dose of 300 mg ABP 692 IV infusion on Day 15. A subsequent dose of 600 mg ABP 692 IV infusion will be administered 24 weeks after the initial dose. |
| Ocrelizumab (US)/ABP 692 | EXPERIMENTAL | Participants affected by RRMS will receive an initial dose of 300 mg Ocrelizumab (US) IV infusion on Day 1, followed by a second dose of 300 mg Ocrelizumab (US) IV infusion on Day 15. At Week 24, the treatment will switch to a 600 mg Ocrelizumab (US) IV infusion of ABP 692. |
| Ocrelizumab (EU) | EXPERIMENTAL | Participants affected by RRMS will receive an initial dose of 300 mg Ocrelizumab (EU) IV infusion on Day 1, followed by a 300 mg Ocrelizumab (EU) IV infusion on Day 15. At Week 24, participants will receive a dose of 600 mg Ocrelizumab (EU) IV infusion. |
| Name | Type | Description |
|---|---|---|
| Ocrelizumab (US) | DRUG | IV infusion |
| Ocrelizumab (EU) | DRUG | IV infusion |
| ABP 692 | DRUG | IV infusion |
Inclusion Criteria: 1. Diagnosis of RRMS in accordance with the revised McDonald Criteria 2017 (Thompson et al, 2018). 2. Expanded Disability Status Scale score at screening ≥ 0 and ≤ 5.5 inclusive. 3. Evidence of recent MS activity as defined by the study protocol. 4. Neurologically stable subject...