Loading clinical trials...

A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

A Phase II, Randomized, Open-label, Parallel Group, Multicenter Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Patients With Multiple Sclerosis

NCT07074886•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Locations (41)

Profound Research, LLC

Carlsbad, California, United States

Advanced Neurology of Colorado, LLC

Fort Collins, Colorado, United States

Neurology Associates PA

Maitland, Florida, United States

Hope Neurology

Knoxville, Tennessee, United States

Centro de Especialidades Neurológicas y Rehabilitación - CENyR

CABA, Buenos Aires, Argentina

Focus CECIC

CABA, CABA / Buenos Aires, Argentina

INECO Neurociencias Orono

Rosario, Santa Fe Province, Argentina

IME - Instituto Médico Especializado

Buenos Aires, Argentina

Centro de Investigacion en Enfermedades Reumaticas CIER

Ciudad Autonoma Buenos Aires, Argentina

Sanatorio del Sur S.A.

San Miguel de Tucumán, Argentina

Key Dates

Start Date

November 13, 2025

Primary Completion Date

January 31, 2027

Completion Date

October 30, 2030

Last Updated

February 4, 2026

Enrollment

182

ESTIMATED participants

Conditions

Multiple Sclerosis

Interventions

Ocrelizumab Test Formulation

DRUG

Ocrelizumab Reference Formulation

DRUG

Contacts

Reference Study ID Number: CN45320 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S.)global-roche-genentech-trials@gene.com

Intermittent Hypoxia in Persons With Multiple Sclerosis

NCT06276634

Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

NCT07225504

Secondary Progressive Multiple Sclerosis (SPMS)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Intermittent Hypoxia in Persons With Multiple Sclerosis

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

Factorial Optimization Trial to Test Cognitive Behavioral Therapy Components for Multiple Sclerosis Fatigue

Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy

Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study

Cognitive Performance, Sleep Disturbances and Fatigue in Multiple Sclerosis