Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis (NCT06847724)
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].
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: Sandoz Investigational Site — Maitland, Florida
Age range: 18 Years to 55 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (41 Sites)
Showing the first 25 of 41 sites.
- Sandoz Investigational Site — Maitland, Florida
- Sandoz Investigational Site — Ormond Beach, Florida
- Sandoz Investigational Site — Banja Luka,
- Sandoz Investigational Site — Bihać,
- Sandoz Investigational Site 2 — Sarajevo,
- Sandoz Investigational Site — Sarajevo,
- 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,
- Sandoz Investigational Site — Varaždin,
- Sandoz Investigational Site — Zagreb,
- 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,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Relapsing Multiple Sclerosis
- A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS) — Fullerton, California
- A Study of Obexelimab in Patients With Relapsing Multiple Sclerosis (MoonStone) — Cullman, Alabama
- Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-2) — Phoenix, Arizona
- A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis. — Birmingham, Alabama
- A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) — Birmingham, Alabama
Explore by condition: All Relapsing Multiple Sclerosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.