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

NCT07667322 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: WN453192024-513639-26-00
• Study Type: interventional
• Target: 75
• Locations: 4 countries
• Sites: 12

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Relapsing Remitting Multiple Sclerosis; Primary Progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  Up to 168 weeks

Secondary Outcomes (3)

• Ocrelizumab Serum Concentration at Specified Timepoints Following Single SC Administration

  Up to 168 weeks

• Number of Participants With Treatment-emergent Anti-drug Antibodies (ADAs) to Ocrelizumab

  Up to 168 weeks

• Number of Participants With Treatment-emergent ADAs to rHuPH20

  Up to 168 weeks

Study Arms (1)

Ocrelizumab SC

EXPERIMENTAL

Participants will receive single ascending doses of ocrelizumab SC, co-formulated with recombinant human hyaluronidase (rHuPH20) on Day 1 of the 24 week dose-escalation phase. Participants who opt to continue treatment in the dose continuation phase will receive ocrelizumab SC at a dose determined in the dose escalation phase, every 24 weeks (Q24W) for 144 weeks.

Drug: Ocrelizumab Co-formulated With rHuPH20

Interventions

Ocrelizumab Co-formulated With rHuPH20 DRUG

Participants will receive ocrelizumab co-formulated with rHuPH20, as a SC injection, per the schedule specified in the treatment arm.

Also known as: RO4964913; Ocrevus®

Ocrelizumab SC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (12)

Profound Research, LLC

Carlsbad, California, 92011, United States

ACTIVE NOT RECRUITING

Neurology Associates, PA

Maitland, Florida, 32751, United States

ACTIVE NOT RECRUITING

University of South Florida

Tampa, Florida, 33612, United States

ACTIVE NOT RECRUITING

Shepherd Center Inc.

Atlanta, Georgia, 30309, United States

ACTIVE NOT RECRUITING

John Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

ACTIVE NOT RECRUITING

Hope Neurology

Knoxville, Tennessee, 37922, United States

ACTIVE NOT RECRUITING

Instituto de Neurologia de Curitiba

Curitiba, Paraná, 81210-310, Brazil

ACTIVE NOT RECRUITING

Centro de Pesquisas Clinicas

São Paulo, São Paulo, 01228-200, Brazil

ACTIVE NOT RECRUITING

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

Guadalajara, Jalisco, 44130, Mexico

RECRUITING

Inovacion y Desarrollo en ciencias de la salud

Mexico City, Mexico CITY (federal District), 14090, Mexico

ACTIVE NOT RECRUITING

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

ACTIVE NOT RECRUITING

Morriston Hospital

Swansea, SA6 6NL, United Kingdom

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: WN45319 https://forpatients.roche.com/

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 25, 2026
• Study Start: December 17, 2024
• Primary Completion (Estimated): February 15, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); BR (2); ME (2); US (6)