Relapsing Multiple SclerosisPhase 3NCT06847724
Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis
A Phase 3 study testing CYB704, Ocrevus-EU and Ocrevus-US in people with Relapsing Multiple Sclerosis, run by Sandoz at 41 sites in 8 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- CYB704, Ocrevus-EU and Ocrevus-US
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 41 sitesin 8 countries
- Study dates
- 10 Jun 2025to May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
41 sites in 8 countries.
41 sites in 8 countries
Poland12 sites
Sandoz Investigational Site
Bydgoszcz
Sandoz Investigational Site 2
Katowice
Sandoz Investigational Site
Katowice
Sandoz Investigational Site
Lodz
Sandoz Investigational Site 2
Lublin
Sandoz Investigational Site
Lublin
Sandoz Investigational Site
Nowa Sól
Sandoz Investigational Site 2
Poznan
Sandoz Investigational Site
Poznan
Sandoz Investigational Site
Szczecin
Sandoz Investigational Site
Warsaw
Sandoz Investigational Site
Zabrze
Georgia9 sites
Sandoz Investigational Site
Rustavi
Sandoz Investigational Site 2
Tbilisi
Sandoz Investigational Site 3
Tbilisi
Sandoz Investigational Site 4
Tbilisi
Sandoz Investigational Site 5
Tbilisi
Sandoz Investigational Site 6
Tbilisi
Sandoz Investigational Site 7
Tbilisi
Sandoz Investigational Site 8
Tbilisi
Sandoz Investigational Site
Tbilisi
Bulgaria8 sites
Sandoz Investigational Site
Pleven
Sandoz Investigational Site 2
Plovdiv
Sandoz Investigational Site
Plovdiv
Sandoz Investigational Site 2
Sofia
Sandoz Investigational Site 3
Sofia
Sandoz Investigational Site 4
Sofia
Sandoz Investigational Site 5
Sofia
Sandoz Investigational Site
Sofia
Bosnia and Herzegovina4 sites
Sandoz Investigational Site
Banja Luka
Sandoz Investigational Site
Bihać
Sandoz Investigational Site 2
Sarajevo
Sandoz Investigational Site
Sarajevo
United States2 sites
Sandoz Investigational Site
Maitland, Florida, 32751
Sandoz Investigational Site
Ormond Beach, Florida, 32174
Croatia2 sites
Sandoz Investigational Site
Varaždin
Sandoz Investigational Site
Zagreb
North Macedonia2 sites
Sandoz Investigational Site
Shtip
Sandoz Investigational Site
Skopje
Serbia2 sites
Sandoz Investigational Site
Belgrade
Sandoz Investigational Site
Niš
About this study
Official title: 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].
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:
Read more
- 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
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- CYB704, Ocrevus-EU, Ocrevus-US
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYB704Biological
Also called Ocrelizumab
Intravenous Infusion
Ocrevus-EUBiological
Also called Ocrelizumab
Intravenous Infusion
Ocrevus-USBiological
Also called Ocrelizumab
Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| CYB704 | Experimental | Drug: CYB704 (Ocrelizumab) Patients will be dosed 300 mg on day 1 and day 15. Subsequent dose of 600 mg will be administered 24 weeks after the initial dose. Receives: Biological: CYB704 |
| Ocrevus-US/Ocrevus-EU | Active comparator | Drug: Ocrevus-US/Ocrevus-EU Patients will be dosed 300 mg on day 1 and day 15 with Ocrevus-US. Subsequent dose of 600 mg Ocrevus-EU will be administered 24 weeks after the initial dose. Receives: Biological: Ocrevus-EU; Biological: Ocrevus-US |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration time curve
Demonstrate similar PK between Ocrevus and CYB704
Measured: Week 1 - 3, week 3 - 25
Secondary outcomes (10)
Area under the plasma concentration versus time curve (AUC)
Compare PK between Ocrevus and CYB704
Measured: Week 1 - 25
Peak Plasma Concentration (Cmax)
Demonstrate similar PK between Ocrevus and CYB704
Measured: Day 1 and Day 15
CD19+ B-cell count
Compare PD between Ocrevus and CYB704
Measured: Up to 48 weeks
Number of new T1 GdE lesions on brain MRI scans
Compare efficacy between Ocrevus and CYB704
Measured: Up to 48 weeks
Number of T1 GdE lesions
Compare efficacy between Ocrevus and CYB704
Measured: Up to 48 weeks
Number of new/enlarging T2 lesions
Compare efficacy between Ocrevus and CYB704
Measured: Up to 48 weeks
Number of combined unique active lesions
Compare efficacy between Ocrevus and CYB704
Measured: Up to 48 weeks
Annualized Relapse Rate
Compare efficacy between Ocrevus and CYB704
Measured: Up to 48 weeks
Treatment emergent Adverse Events and Serious Adverse Events
Compare safety between Ocrevus and CYB704
Measured: Up to 48 weeks
Rate of patients with anti-drug antibodies
Compare immunogenicity between Ocrevus and CYB704
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start10 Jun 2025
- Primary completionNov 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847724
- Sponsor's protocol ID
- CCYB704A12301
- Status last verified
- May 2026
- First submitted
- 19 Feb 2025
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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].
- ClinicalTrials.gov ID
- NCT06847724
- Acronym / sponsor ID
- CCYB704A12301
- Conditions
- Relapsing Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 183 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CYB704 | Experimental | Biological: CYB704Drug: CYB704 (Ocrelizumab) Patients will be dosed 300 mg on day 1 and day 15. Subsequent dose of 600 mg will be administered 24 weeks after the initial dose. |
| Ocrevus-US/Ocrevus-EU | Active comparator | Biological: Ocrevus-EU, Biological: Ocrevus-USDrug: Ocrevus-US/Ocrevus-EU Patients will be dosed 300 mg on day 1 and day 15 with Ocrevus-US. Subsequent dose of 600 mg Ocrevus-EU will be administered 24 weeks after the initial dose. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYB704Also: OcrelizumabIntravenous Infusion | Biological | CYB704 |
| Ocrevus-EUAlso: OcrelizumabIntravenous Infusion | Biological | Ocrevus-US/Ocrevus-EU |
| Ocrevus-USAlso: OcrelizumabIntravenous Infusion | Biological | Ocrevus-US/Ocrevus-EU |
Primary outcome
Area under the concentration time curve
Time frame: Week 1 - 3, week 3 - 25
Demonstrate similar PK between Ocrevus and CYB704
10 secondary outcomes
Area under the plasma concentration versus time curve (AUC)
Time frame: Week 1 - 25
Peak Plasma Concentration (Cmax)
Time frame: Day 1 and Day 15
CD19+ B-cell count
Time frame: Up to 48 weeks
Number of new T1 GdE lesions on brain MRI scans
Time frame: Up to 48 weeks
Number of T1 GdE lesions
Time frame: Up to 48 weeks
Number of new/enlarging T2 lesions
Time frame: Up to 48 weeks
Number of combined unique active lesions
Time frame: Up to 48 weeks
Annualized Relapse Rate
Time frame: Up to 48 weeks
Treatment emergent Adverse Events and Serious Adverse Events
Time frame: Up to 48 weeks
Rate of patients with anti-drug antibodies
Time frame: Up to 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
41 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CYB704, Ocrevus-EU and Ocrevus-US in people with Relapsing Multiple Sclerosis, run by Sandoz at 41 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Poland, Georgia, Bulgaria, Bosnia and Herzegovina, United States and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration time curve (time frame: Week 1 - 3, week 3 - 25). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.