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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Drug: Ocrelizumab Test Formulation
    Ocrelizumab test formulation will be administered as per the schedule specified in the respective arm.
    Other names:
    • RO4964913
Active Comparator
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.
  • Drug: Ocrelizumab Test Formulation
    Ocrelizumab test formulation will be administered as per the schedule specified in the respective arm.
    Other names:
    • RO4964913
  • Drug: Ocrelizumab Reference Formulation
    Ocrelizumab reference formulation will be administered as per the schedule specified in the respective arm.
    Other names:
    • RO4964913

Recruiting Locations

Profound Research, LLC
Carlsbad 5334223, California 5332921 92011

Advanced Neurology of Colorado, LLC
Fort Collins 5577147, Colorado 5417618 80528

Neurology Associates PA
Maitland 4163220, Florida 4155751 32751

Hope Neurology
Knoxville 4634946, Tennessee 4662168 37922

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: CN45320 https://forpatients.roche.com/
888-662-6728 (U.S.)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.