Clinical Trial

A Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of RPH-035 and Ocrevus® in Patients With Relapsing-remitting or Secondary Progressive Multiple Sclerosis With Exacerbations

Active, Not Recruiting Phase 1
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Summary
The study goal is to establish the equivalence of pharmacokinetic (PK) properties, as well as the comparability of safety, immunogenicity (IG) and pharmacodynamics (PD) of the drug product RPH-035 (R-Pharm JSC, Russia) in comparison with the drug product Ocrevus® (F. Hoffmann-La Roche Ltd., Switzerland) when used in patients with multiple sclerosis (MS)
Protocol Amendment History 1 change
notable Primary completion pushed: 2026-01-12 -> 2026-06-02 2026-07-15
Trial Details
NCT Number NCT07597668
Lead Sponsor R-Pharm
Conditions Multiple Sclerosis
Enrollment 180 participants
Start Date 2025-04-16
Primary Completion 2026-06-02 (estimated)
Study Completion 2027-11-24 (estimated)
Updated on ClinicalTrials.gov 2026-07-14