CYB704 vs Ocrevus for Multiple Sclerosis

Recruiting at 30 trial locations

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

175 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new drug, CYB704, is as effective as Ocrevus for treating multiple sclerosis (MS). Researchers aim to determine if the body uses CYB704 similarly and if it has comparable effects and side effects to Ocrevus. Participants will receive either CYB704 or Ocrevus and attend at least 15 clinic visits, including MRIs. This trial suits individuals diagnosed with relapsing-remitting or active secondary progressive MS who have experienced recent disease activity and no new CNS symptoms in the last 30 days. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment option.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop your current medications, but it mentions that some medications are prohibited. It's best to discuss your current medications with the trial team to see if any changes are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that CYB704, a new drug similar to Ocrevus, is being tested for its effectiveness in treating multiple sclerosis. Currently, detailed information about the safety of CYB704 is limited, as no comprehensive reports on its side effects exist. However, Ocrevus, which is already approved, provides some insights.

Ocrevus has demonstrated that the most common side effect is a reaction to the injection, occurring in about 49% of patients. This reaction can include skin issues or fever and may happen during or shortly after treatment. Since CYB704 is designed to resemble Ocrevus, it might exhibit similar side effects.

The trial is in a late stage, indicating that the drug has been safe enough in earlier phases. This suggests that the treatment has been fairly well-tolerated by patients so far. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about CYB704 for multiple sclerosis because it may offer a new approach to managing the disease. Unlike some other treatments, CYB704 is a special formulation of ocrelizumab, which is already known for its effectiveness in targeting B-cells, a key player in the progression of multiple sclerosis. This new formulation could potentially enhance the drug's efficacy or safety profile. Additionally, the dosing schedule of CYB704 mirrors that of current ocrelizumab treatments, offering familiarity while possibly improving outcomes. This combination of proven mechanisms with potential refinements is what has researchers hopeful for better management of multiple sclerosis.

What evidence suggests that this trial's treatments could be effective for multiple sclerosis?

Research has shown that Ocrevus effectively treats multiple sclerosis, helping to prevent the condition from worsening. Specifically, after two years, 90.5% of patients with relapsing-remitting MS (RRMS) did not experience any symptom worsening, indicating Ocrevus's strong potential to stabilize symptoms.

In this trial, participants will receive either CYB704 or Ocrevus. CYB704 is being tested as a biosimilar to Ocrevus, designed to work similarly. Although direct data on CYB704 is limited, the aim is for it to be as effective and safe as Ocrevus. If successful, CYB704 could offer similar benefits for managing multiple sclerosis. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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-US/Ocrevus-EU Active Control 2 Interventions

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.

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06847724

Study Details | NCT06847724 | An Efficacy and Safety ... 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06847724?term=AREA%5BBasicSearch%5D(ocrelizumab)&rank=1

Study Details | NCT06847724 | An Efficacy and Safety ... 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 ...

3. withpower.com withpower.com/trial/phase-3-multiple-sclerosis-3-2025-84a3a

CYB704 vs Ocrevus for Multiple Sclerosis This Phase 3 medical study run by Sandoz is evaluating whether CYB704, Ocrevus-EU and Ocrevus-US will have tolerable side effects & efficacy for patients ...

4. clinconnect.io clinconnect.io/trials/NCT06847724

An Efficacy and Safety Study With Integrated - ClinConnect This clinical trial is studying a new medication called CYB704, which is similar to an existing treatment for relapsing multiple sclerosis (MS) called Ocrevus.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8457546/

Predictors of Ocrelizumab Effectiveness in Patients with ... At 2-year follow-up (FU), disability worsening-free survival were 90.5%, 64.7%, and 68.8% for RRMS, primary-progressive MS (PPMS), and secondary ...

6. tipranks.com tipranks.com/news/company-announcements/sandozs-biosimilar-trial-a-potential-game-changer-for-multiple-sclerosis-treatment

Sandoz's Biosimilar Trial: A Potential Game-Changer for ... The study aims to determine if CYB704, a proposed biosimilar to Ocrevus, matches the original in distribution, efficacy, and safety, which is ...

7. ocrevus-hcp.com ocrevus-hcp.com/ocrevus/safety.html

Safety | OCREVUS® (ocrelizumab) The most common adverse reaction observed with OCREVUS ZUNOVO in patients with RMS and PPMS was injection reactions (incidence of 49%).