A Randomized, Double-blind, Parallel-group Study to Compare the Pharmacokinetics, Efficacy, Pharmacodynamics, Safety, and Immunogenicity of CYB704 (Proposed Ocrelizumab Biosimilar) and Ocrevus® (EU-authorized and US-licensed) in Participants With Relapsing Multiple Sclerosis (RMS)

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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 a t least 15 treatment visits, checkups and tests * Will undergo regular magnetic resonance imaging (MRI) examinations

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• Diagnosis of RMS (relapsing remitting multiple sclerosis (MS) and 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

Locations
United States
Florida
Sandoz Investigational Site
RECRUITING
Maitland
Sandoz Investigational Site
RECRUITING
Ormond Beach
Other Locations
Bosnia and Herzegovina
Sandoz Investigational Site
RECRUITING
Banja Luka
Sandoz Investigational Site
RECRUITING
Sarajevo
Bulgaria
Sandoz Investigational Site
RECRUITING
Pleven
Sandoz Investigational Site
RECRUITING
Plovdiv
Sandoz Investigational Site
RECRUITING
Sofia
Croatia
Sandoz Investigational Site
RECRUITING
Varaždin
Sandoz Investigational Site
RECRUITING
Zagreb
Georgia
Sandoz Investigational Site
RECRUITING
Rustavi
Sandoz Investigational Site
RECRUITING
Tbilisi
Poland
Sandoz Investigational Site
RECRUITING
Bydgoszcz
Sandoz Investigational Site
RECRUITING
Katowice
Sandoz Investigational Site
RECRUITING
Lodz
Sandoz Investigational Site
RECRUITING
Nowa Sól
Sandoz Investigational Site
RECRUITING
Poznan
Sandoz Investigational Site
RECRUITING
Warsaw
Sandoz Investigational Site
RECRUITING
Zabrze
Serbia
Sandoz Investigational Site
RECRUITING
Belgrade
Sandoz Investigational Site
RECRUITING
Niš
Contact Information
Primary
Clinical Disclosure Representative
sandoz.disclosure@sandoz.net
+49 8024 / 908 0
Time Frame
Start Date: 2025-06-10
Estimated Completion Date: 2029-10-14
Participants
Target number of participants: 518
Treatments
Experimental: CYB704
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.
Active_comparator: Ocrevus-EU
Drug: Ocrevus-EU 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.
Active_comparator: Ocrevus-US
Drug: Ocrevus-US 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.
Sponsors
Leads: Sandoz

This content was sourced from clinicaltrials.gov