A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)

Not Applicable

Not yet recruiting

• Conditions: Multiple Sclerosis
• Interventions: Drug: Ocrelizumab Test Formulation; Drug: Ocrelizumab Reference Formulation

• Registration Number: NCT07074886
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

The main purpose of this study is to assess the bioequivalence of ocrelizumab SC test formulation to the marketed ocrelizumab SC reference formulation in participants with either relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). The study consists of 2 phases: a controlled phase, where participants in each group will receive one dose of test or reference formulation and a continuation phase, where all participants in both groups will receive ocrelizumab SC test formulation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-17
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-20
• Study Start: 2025-09-30
• Primary Completion: 2027-01-31
• Study Completion: 2030-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

• Diagnosis of RMS or PPMS according to the revised McDonald 2017 criteria (Thompson et al. 2018) or the most current McDonald criteria at the time of study start
• Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening

Exclusion Criteria

• Participants who have previously received anti-cluster of differentiation (CD)20s (including ocrelizumab) less than 2 years before screening
• Participants who have previously received anti-CD20s (including ocrelizumab) more than 2 years before screening if one of the following conditions is met: B-cell count is below lower limit of normal (LLN), or the discontinuation of the treatment was due to safety reasons
• History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
• History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
• Immunocompromised state
• Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
• Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
• Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude participation in the study
• Lack of peripheral venous access
• Previous treatment with cladribine, atacicept, and alemtuzumab
• Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
• Any previous history of transplantation or anti-rejection therapy
• Positive screening tests for active, latent, or inadequately treated hepatitis B virus (HBV)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ocrelizumab Test Formulation	Ocrelizumab Test Formulation	Participants will receive ocrelizumab test formulation, as SC injection, as per a pre-defined dosing regimen during the controlled phase and continuation phase.
Ocrelizumab Reference Formulation	Ocrelizumab Test Formulation	Participants will receive ocrelizumab reference formulation, 920 mg, as SC injection, on Day 1 during the controlled phase. Thereafter, participants will receive ocrelizumab test formulation, as SC injection, as per a pre-defined dosing regimen during the continuation phase.
Ocrelizumab Reference Formulation	Ocrelizumab Reference Formulation	Participants will receive ocrelizumab reference formulation, 920 mg, as SC injection, on Day 1 during the controlled phase. Thereafter, participants will receive ocrelizumab test formulation, as SC injection, as per a pre-defined dosing regimen during the continuation phase.

Primary Outcome Measures

Name	Time	Method
Area Under the Serum Concentration-time Curve (AUC) of Ocrelizumab	Up to 12 weeks
Maximum Serum Concentration (Cmax) of Ocrelizumab	Up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	Up to 168 weeks