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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

NCT07597668 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-05-19

No results posted yet for this study

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)

Conditions

Interventions

DRUG

RPH-035

300 mg/10 mL (30 mg/mL) concentrate for solution for infusions in a single-dose vial For the 1st and 2nd infusions, 300 mg (10 mL) of ocrelizumab is diluted in 0.9% sodium chloride to a final concentration of approximately 1.2 mg/mL. For the 3rd infusion, 600 mg (20 mL) of ocrelizumab is diluted in 0.9% sodium chloride to a final concentration of approximately 1.2 mg/mL

DRUG

Ocrevus®

300 mg/10 mL (30 mg/mL) concentrate for solution for infusions in a single-dose vial For the 1st and 2nd infusions, 300 mg (10 mL) of ocrelizumab is diluted in 0.9% sodium chloride to a final concentration of approximately 1.2 mg/mL. For the 3rd infusion, 600 mg (20 mL) of ocrelizumab is diluted in 0.9% sodium chloride to a final concentration of approximately 1.2 mg/mL

Sponsors & Collaborators

  • R-Pharm

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · R-Pharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-16
Primary Completion
2026-01-12
Completion
2027-12-20

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07597668 on ClinicalTrials.gov