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Also known as Ocrelizumab (US)
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 | ACTIVE_COMPARATOR | 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 IV infusion of ABP 692. |
| Ocrelizumab (EU) | ACTIVE_COMPARATOR | 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...
Ocrelizumab is an investigational small molecule being developed for the treatment of Relapsing-remitting Multiple Sclerosis (RRMS). It is currently in Phase 3 clinical development. The drug is being studied in a randomized, double-blind, active-controlled trial to evaluate its efficacy and safety in patients with RRMS.
Ocrelizumab targets MS4A1, a membrane-spanning protein. As a binding agent, it is designed to interact with this target, which is relevant to the pathology of Relapsing-remitting Multiple Sclerosis. The drug's mechanism involves binding to MS4A1, though the specific downstream effects are part of its investigational profile.
Ocrelizumab is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The company is conducting a Phase 3 clinical trial to assess the drug's potential as a treatment for Relapsing-remitting Multiple Sclerosis.
Ocrelizumab is in Phase 3 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 3 trial is active but not recruiting participants, with an enrollment target of 152 patients.
Ocrelizumab is being studied in a single Phase 3 clinical trial registered as NCT06700343, titled 'Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)'. This randomized, double-blind, active-controlled study enrolls 152 participants with Relapsing-remitting Multiple Sclerosis across multiple countries, including the United States and several European nations.
Ocrelizumab is being compared to Ocrevus (also known as ocrelizumab) in a clinical trial. The study NCT06700343 is designed to compare ABP 692, which is the investigational drug, against Ocrevus. This suggests Ocrelizumab may be a biosimilar or alternative version of the reference product Ocrevus.