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Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis
Led by Sandoz · Updated on 2026-04-27
175
Participants Needed
41
Research Sites
226 weeks
Total Duration
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AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsing remitting multiple sclerosis or active secondary progressive multiple sclerosis
- 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 with no new signs or symptoms related to CNS within 30 days before screening and first study treatment
You will not qualify if you...
- Diagnosis of primary progressive multiple sclerosis
- Disease duration over 10 years if Expanded Disability Status Scale (EDSS) is 2.0 or less at screening
- Unable to complete MRI or contraindicated for gadolinium use
- History of allergic or anaphylactic reactions to ocrelizumab or premedications like methylprednisolone, antihistamines, or antipyretics
- Pregnant participants
- Current or history of certain medical conditions as detailed in the study protocol
- Use of prohibited medications currently or in the past as detailed in the study protocol
- Abnormal laboratory blood values as specified in the study protocol
AI-Screening
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Trial Site Locations
Total: 41 locations
1
Sandoz Investigational Site
Maitland, Florida, United States, 32751
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2
Sandoz Investigational Site
Ormond Beach, Florida, United States, 32174
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3
Sandoz Investigational Site
Banja Luka, Bosnia and Herzegovina
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4
Sandoz Investigational Site
Bihać, Bosnia and Herzegovina
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5
Sandoz Investigational Site 2
Sarajevo, Bosnia and Herzegovina
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6
Sandoz Investigational Site
Sarajevo, Bosnia and Herzegovina
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7
Sandoz Investigational Site
Pleven, Bulgaria
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8
Sandoz Investigational Site 2
Plovdiv, Bulgaria
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9
Sandoz Investigational Site
Plovdiv, Bulgaria
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10
Sandoz Investigational Site 2
Sofia, Bulgaria
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11
Sandoz Investigational Site 3
Sofia, Bulgaria
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12
Sandoz Investigational Site 4
Sofia, Bulgaria
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13
Sandoz Investigational Site 5
Sofia, Bulgaria
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14
Sandoz Investigational Site
Sofia, Bulgaria
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15
Sandoz Investigational Site
Varaždin, Croatia
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16
Sandoz Investigational Site
Zagreb, Croatia
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17
Sandoz Investigational Site
Rustavi, Georgia
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18
Sandoz Investigational Site 2
Tbilisi, Georgia
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19
Sandoz Investigational Site 3
Tbilisi, Georgia
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20
Sandoz Investigational Site 4
Tbilisi, Georgia
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21
Sandoz Investigational Site 5
Tbilisi, Georgia
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22
Sandoz Investigational Site 6
Tbilisi, Georgia
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23
Sandoz Investigational Site 7
Tbilisi, Georgia
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24
Sandoz Investigational Site 8
Tbilisi, Georgia
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25
Sandoz Investigational Site
Tbilisi, Georgia
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26
Sandoz Investigational Site
Shtip, North Macedonia
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27
Sandoz Investigational Site
Skopje, North Macedonia
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28
Sandoz Investigational Site
Bydgoszcz, Poland
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29
Sandoz Investigational Site 2
Katowice, Poland
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30
Sandoz Investigational Site
Katowice, Poland
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31
Sandoz Investigational Site
Lodz, Poland
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32
Sandoz Investigational Site 2
Lublin, Poland
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33
Sandoz Investigational Site
Lublin, Poland
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34
Sandoz Investigational Site
Nowa Sól, Poland
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35
Sandoz Investigational Site 2
Poznan, Poland
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36
Sandoz Investigational Site
Poznan, Poland
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37
Sandoz Investigational Site
Szczecin, Poland
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38
Sandoz Investigational Site
Warsaw, Poland
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39
Sandoz Investigational Site
Zabrze, Poland
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40
Sandoz Investigational Site
Belgrade, Serbia
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41
Sandoz Investigational Site
Niš, Serbia
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Research Team
C
Clinical Disclosure Representative
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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