A Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of RPH-035 … (NCT07597668) | Clinical Trial Compass
Active — Not RecruitingPhase 1
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
Russia180 participantsStarted 2025-04-16
Plain-language 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)
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Availability of the voluntarily signed and dated patient Informed Consent (IC) form for participation in this study
. Multiple sclerosis with exacerbations (relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS) with exacerbations) according to the McDonald diagnostic criteria as revised in 2017, with symptoms lasting at least 1 year before signing the IC form
. The patient's medical history includes the use of ≤ 3 prior multiple sclerosis disease modifying drugs (DMT)
. The patient has one of the following signs of disease activity:
. ≥ 2 documented disease exacerbations in the previous 24 months before the IC signing date
. ≥ 1 documented disease exacerbation in the previous 12 months before the IC signing date
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The area under the concentration-time pharmacokinetic curve (AUC (14-169 days)) of ocrelizumab
. 1 documented exacerbation in the previous 24 months before the IC signing date and ≥ 1 documented brain lesion on the contrast-enhanced Magnetic Resonance Imaging (MRI) scan in the previous 6 months before the IC signing date
. Expanded Disability Status Scale (EDSS) index is 0-5.5 points inclusively on screening
Exclusion criteria
. Medical history of hypersensitivity to monoclonal antibody drugs or to any component of the investigational medicinal products
. Prior therapy with ocrelizumab
. Primary progressive multiple sclerosis or SPMS without exacerbations
. Contraindications for MRI, including intolerance to Gd-containing contrast agents and claustrophobia
. Medical history of other neurological diseases (excluding migraines) or first diagnosed on screening, including but not limited to the following: