Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704… (NCT06847724) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis
United States, Bosnia and Herzegovina, Bulgaria183 participantsStarted 2025-06-10
Plain-language summary
The goal of this clinical trial is to learn if drug CYB704, a proposed biosimilar to Ocrevus, works to treat multiple sclerosis in the same way as the reference product Ocrevus(R).
The main questions it aims to answer are:
* Is CYB704 distributed in the body in the same way as the reference product (demonstration of pharmacokinetic (PK) similarity)?
* Does have CYB704 the same treatment effect and side effects as the reference product?
Researchers will compare CYB704 to a Ocrevus (Ocrevus-US and Ocrevus-EU). Participants will:
* Take drug CYB704 or Ocrevus (Ocrevus-US and Ocrevus-EU)
* Visit the clinic for at least 15 treatment visits, checkups and tests
* Will undergo regular magnetic resonance imaging (MRI) examinations
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:
* Diagnosis of RMS (relapsing remitting multiple sclerosis (MS) or active secondary progressive MS)
* Evidence of recent disease activity as defined in study protocol
* Expanded Disability Status scale score of 0 to 5.5 (inclusive) at screening
* Neurological stability (no new signs or symptoms referable to Central Nervous System (CNS) within 30 days before both screening and first study treatment
Exclusion Criteria:
* Diagnosis of primary progressive MS
* Disease duration of more than 10 years in participants with an Expanded Disability Status Scale (EDSS) ≤2.0 at screening
* Inability to complete an MRI or contraindication to gadolinium administration
* History of allergic or anaphylactic reactions to ocrelizumab or one of the premedications (methylprednisolone or equivalent corticosteroid, antihistamine, antipyretic)
* Pregnant participants
* Current or history of medical conditions as outlined in the study protocol
* Prohibited medications (current and history) as outlined in the study protocol
* Abnormal laboratory blood values as outlined in the study protocol
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.