CYB704 vs Ocrevus for Multiple Sclerosis

Recruiting at 1 trial location

Overseen By Clinical Disclosure Representative

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Sandoz

Disqualifiers: Primary progressive MS, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

Duration: 24 weeks

518 Participants Needed

Trial Summary

What is the purpose of this trial?

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 Criteria

This trial is for individuals with Relapsing Multiple Sclerosis (RMS) who have shown recent disease activity, have an Expanded Disability Status scale score of 0 to 5.5, and no new CNS symptoms in the last 30 days.

Inclusion Criteria

I haven't had new brain-related symptoms in the last 30 days.

My condition has shown recent signs of worsening.

My disability score is between 0 and 5.5.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CYB704 or Ocrevus with initial doses of 300 mg on day 1 and day 15, followed by a 600 mg dose 24 weeks after the initial dose

24 weeks

At least 15 treatment visits, checkups, and tests

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI examinations and assessment of B-cell counts

24 weeks

Long-term Follow-up

Participants are monitored for long-term safety and efficacy, including assessment of new lesions and relapse rates

48 weeks

Treatment Details

Interventions

• CYB704
• Ocrevus-EU
• Ocrevus-US

Trial Overview The study tests CYB704, a proposed biosimilar to Ocrevus, against the original Ocrevus versions from the US and EU. It checks if CYB704 has similar distribution in the body (PK), effectiveness, and side effects as Ocrevus.

Participant Groups

Group I: CYB704 Experimental Treatment 1 Intervention

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.

Group II: Ocrevus-EU Active Control 1 Intervention

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.

Group III: Ocrevus-US Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Sandoz

Lead Sponsor

Trials

145

Recruited

26,800+

Dr. David Chang

Sandoz

Chief Medical Officer

MD from Albert Einstein College of Medicine

Richard Saynor

Sandoz

Chief Executive Officer since 2019

Bachelor of Pharmacy from the University of Bradford