NCT06847724Active, not recruitingPhase 3
Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis
A Randomized, Double-blind, Parallel-group Study to Compare the Pharmacokinetics, Efficacy, Pharmacodynamics, Safety, and Immunogenicity of CYB704 (Proposed Ocrelizumab Biosimilar) and Ocrevus® in Participants With Relapsing Multiple Sclerosis (RMS) [STRIVE-MS].
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 183 (actual)
- First submitted
- 19 Feb 2025
- Start date
- 10 Jun 2025
- Primary completion date
- Nov 2026
- Lead sponsor
- Sandoz
- Diseases
- Multiple sclerosis
- NCT number
- NCT06847724
- EU CT number
- 2024-512319-40-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 183
- From 10 Jun 2025 to the primary completion date, Nov 2026
- 41 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prohibited medications (current and history) as outlined in the study protocol
Other illness
- Disease duration of more than 10 years in participants with an Expanded Disability Status Scale (EDSS) ≤2.0 at screening
- History of allergic or anaphylactic reactions to ocrelizumab or one of the premedications (methylprednisolone or equivalent corticosteroid, antihistamine, antipyretic)
- Current or history of medical conditions as outlined in the study protocol
Lab values
- Abnormal laboratory blood values as outlined in the study protocol
Other
- Diagnosis of primary progressive MS
- Inability to complete an MRI or contraindication to gadolinium administration
- Pregnant participants
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (41)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Center Academica 2008 EOOD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Active, not recruiting |
| Multiprofile Hospital For Active Treatment Medical Complex Sveti Ivan Rilski EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Active, not recruiting |
| University Multiprofile Hospital For Active Treatment Saint Georgi EAD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Active, not recruiting |
| Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Active, not recruiting |
| Medical Center Medica 2005 EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Active, not recruiting |
| University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Active, not recruiting |
| Diagnostics And Consultation Center Convex Ltd. Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Active, not recruiting |
| Acibadem City Clinic Tokuda University Hospital EAD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Rustavi | Georgia | Unknown status |
| - Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| - Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| - Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| - Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| - Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| - Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| - Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| - Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Opca Bolnica Varazdin Coordinator of this site? Confirm its status | Varazdin | Croatia | Active, not recruiting |
| University Hospital Centre Zagreb Coordinator of this site? Confirm its status | Zagreb | Croatia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Shtip | North Macedonia | Unknown status |
| - Coordinator of this site? Confirm its status | Skopje | North Macedonia | Unknown status |
| Neurocentrum Bydgoszcz sp. z o.o Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Active, not recruiting |
| MA-LEK Clinical Sp. z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Active, not recruiting |
| NEURO-MEDIC Sp. z o. o. Coordinator of this site? Confirm its status | Katowice | Poland | Active, not recruiting |
| Centrum Neurologii Krzysztof Selmaj Coordinator of this site? Confirm its status | Łódź | Poland | Active, not recruiting |
| Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Zanamed Medical Clinic Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Nowa Sol | Poland | Active, not recruiting |
| Ilkowski I Partnerzy sp.p. Lekarzy Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Med Polonia Sp z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| EUROMEDIS Sp z o o Coordinator of this site? Confirm its status | Szczecin | Poland | Active, not recruiting |
| Centrum Medyczne NeuroProtect Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach Coordinator of this site? Confirm its status | Zabrze | Poland | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| - Coordinator of this site? Confirm its status | Niš | Serbia | Unknown status |
| - Coordinator of this site? Confirm its status | Maitland | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Ormond Beach | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Banja Luka | Bosnia and Herzegovina | Unknown status |
| - Coordinator of this site? Confirm its status | Bihać | Bosnia and Herzegovina | Unknown status |
| - Coordinator of this site? Confirm its status | Sarajevo | Bosnia and Herzegovina | Unknown status |
| - Coordinator of this site? Confirm its status | Sarajevo | Bosnia and Herzegovina | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.