drugset / Trial / NCT06700343
Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)
RandomizedParallel-groupDouble-blindTreatment
Summary
The main objectives of the study are to demonstrate pharmacokinetics (PK) similarity between ABP 692 and Ocrelizumab (US), and ABP 692 and Ocrelizumab (EU), and to demonstrate pharmacodynamics (PD) similarity between ABP 692 and Ocrelizumab reference product (RP) based on assessment of the suppression of new active brain lesions over 24 weeks as assessed by magnetic brain imaging (MRI).
Timeline
- Start
- 2025-01-13
- Primary completion
- 2027-01-15
- Completion
- 2027-12-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ABP 692 | Unknown | 600 mg | Intravenous |
| Subject | Ocrelizumab | Monoclonal antibody | 600 mg | Intravenous |