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NCT07667322PHASE1Recruiting

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a New Subcutaneous Formulation of Ocrelizumab in Participants With Multiple Sclerosis

Hoffmann-La Roche

Start Date

12/17/2024

Completion Date

8/1/2028

Summary

The main purpose of this study is to evaluate the safety and tolerability of the ocrelizumab subcutaneous (SC) test formulation in participants with multiple sclerosis (MS). The study consists of two treatment phases: a dose-escalation and dose-continuation phase. Participants will receive single ascending doses of ocrelizumab SC during an initial dose-escalation phase, with the option to continue treatment with the selected dose of ocrelizumab SC in the dose-continuation phase.

Eligibility Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: * Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Relapsing Multiple Sclerosis (RMS) according to the revised McDonald 2017 criteria (Thompson et al. 2018) * Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening Exclusion Criteria: * Participants who have previously received anti-cluster of differentiation 20 (CD20s) (including ocrelizumab) less than 2 years before screening * Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antimicrobials within 8 weeks prior to and during screening or treatment with oral antimicrobials within 2 weeks prior to and during screening * 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 * 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 (including cardiac arrhythmia), pulmonary (including obstructive pulmonary disease), 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 * Previous treatment with fingolimod, siponimod, ponesimod, or ozanimod within 6 weeks of baseline * 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 * Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab

Interventions

DRUG

Ocrelizumab Co-formulated With rHuPH20

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Conditions

Multiple Sclerosis

Locations

Profound Research, LLC

Carlsbad, California 92011

United States

Neurology Associates, PA

Maitland, Florida 32751

United States

University of South Florida

Tampa, Florida 33612

United States

Shepherd Center Inc.

Atlanta, Georgia 30309

United States

John Hopkins University School of Medicine

Baltimore, Maryland 21287

United States

Hope Neurology

Knoxville, Tennessee 37922

United States

Instituto de Neurologia de Curitiba

Curitiba, Paraná 81210-310

Brazil

Centro de Pesquisas Clinicas

São Paulo, São Paulo 01228-200

Brazil

Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.

Guadalajara, Jalisco 44130

Mexico

Inovacion y Desarrollo en ciencias de la salud

Mexico City, Mexico CITY (federal District) 14090

Mexico

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH

United Kingdom

Morriston Hospital

Swansea, SA6 6NL

United Kingdom