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RECRUITING
NCT07667322
PHASE1

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Official title: A Phase 1b Multicenter, Non-randomized, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Single Ascending Doses of a New Subcutaneous Formulation of Ocrelizumab in Patients With Multiple Sclerosis

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2024-12-17

Completion Date

2028-08-01

Last Updated

2026-06-25

Healthy Volunteers

No

Interventions

DRUG

Ocrelizumab Co-formulated With rHuPH20

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

Locations (12)

Profound Research, LLC

Carlsbad, California, United States

Neurology Associates, PA

Maitland, Florida, United States

University of South Florida

Tampa, Florida, United States

Shepherd Center Inc.

Atlanta, Georgia, United States

John Hopkins University School of Medicine

Baltimore, Maryland, United States

Hope Neurology

Knoxville, Tennessee, United States

Instituto de Neurologia de Curitiba

Curitiba, Paraná, Brazil

Centro de Pesquisas Clinicas

São Paulo, São Paulo, Brazil

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

Guadalajara, Jalisco, Mexico

Inovacion y Desarrollo en ciencias de la salud

Mexico City, Mexico CITY (federal District), Mexico

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Morriston Hospital

Swansea, United Kingdom