drugset / Trial / NCT06700343

Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

NCT06700343

Phase 3 Active not recruiting 152 enrolled Amgen
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

EvaluationDrugModalityDoseRoute
Subject ABP 692 Unknown 600 mg Intravenous
Subject Ocrelizumab Monoclonal antibody 600 mg Intravenous