An Efficacy and Safety Study With Integrated Pharmacokinetics (PK) and Pharmacodynamic (PD) Assessment to Compare the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis (RMS)

Sandoz

Status and phase: Enrolling; Phase 3

Conditions: Relapsing Multiple Sclerosis

Treatments: Biological: CYB704; Biological: Ocrevus-EU; Biological: Ocrevus-US

Study type: Interventional

Funder types: Industry

Identifiers

NCT06847724

CCYB704A12301

Details and patient eligibility

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 a t least 15 treatment visits, checkups and tests
• Will undergo regular magnetic resonance imaging (MRI) examinations

Enrollment: 518 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Diagnosis of primary progressive MS
• Disease duration of more than 10 years in participants with an Expanded Disability Status Scale (EDSS) ≤2.0 at screening
• Inability to complete an MRI or contraindication to gadolinium administration
• History of allergic or anaphylactic reactions to ocrelizumab or one of the premedications (methylprednisolone or equivalent corticosteroid, antihistamine, antipyretic)
• Pregnant participants
• Current or history of medical conditions as outlined in the study protocol
• Prohibited medications (current and history) as outlined in the study protocol
• Abnormal laboratory blood values as outlined in the study protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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518 participants in 3 patient groups

CYB704

Experimental group

Description:

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.

Treatment:

Biological: CYB704

Ocrevus-EU

Active Comparator group

Description:

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.

Treatment:

Biological: Ocrevus-EU

Ocrevus-US

Active Comparator group

Description:

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.

Treatment:

Biological: Ocrevus-US