A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Pharmacodynamics, Clinical Effects, and Safety between ABP 692 and Ocrevus® (Ocrelizumab) in Subjects with Relapsing-remitting Multiple Sclerosis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512914-16-00

Acronym

20230309

Enrollment

370

Registered

2025-03-18

Start date

2025-09-12

Completion date

Unknown

Last updated

2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing-remitting Multiple Sclerosis

Brief summary

Area under the serum concentration-time curve (AUC) from time 0 to day 15 (AUC0-d15) following infusion 1 of the initial dose, AUC from time 0 extrapolated to infinity (AUC0-inf) of the entire initial dose, Total number of new GdE T1-weighted lesions (assessed by brain MRI) over weeks 4, 8, 12, 16, 20, and 24

Interventions

DRUGOcrevus 300 mg concentrate for solution for infusion

DRUGOcrevus

DRUGABP 692

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Area under the serum concentration-time curve (AUC) from time 0 to day 15 (AUC0-d15) following infusion 1 of the initial dose, AUC from time 0 extrapolated to infinity (AUC0-inf) of the entire initial dose, Total number of new GdE T1-weighted lesions (assessed by brain MRI) over weeks 4, 8, 12, 16, 20, and 24	—

Countries

Belgium, Bulgaria, Croatia, Czechia, Denmark, France, Germany, Italy, Lithuania, Poland, Slovakia, Slovenia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026