RecruitingRecruiting
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a New Subcutaneous Formulation of Ocrelizumab in Participants With Multiple Sclerosis
NCT07667322 · Hoffmann-La Roche
In plain English
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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
About this study
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
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
Study design
Enrollment target: 75 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-12-17
Estimated completion: 2028-08-01
Last updated: 2026-06-25
Interventions
Drug: Ocrelizumab Co-formulated With rHuPH20
Primary outcomes
- • Number of Participants With Adverse Events (AEs) (Up to 168 weeks)
Sponsor
Hoffmann-La Roche · industry
Contacts & investigators
ContactReference Study ID Number: WN45319 https://forpatients.roche.com/ · contact · global-roche-genentech-trials@gene.com · 888-662-6728 (U.S. Only)
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (12)
Profound Research, LLCActive Not Recruiting
Carlsbad, California, United States
Neurology Associates, PAActive Not Recruiting
Maitland, Florida, United States
University of South FloridaActive Not Recruiting
Tampa, Florida, United States
Shepherd Center Inc.Active Not Recruiting
Atlanta, Georgia, United States
John Hopkins University School of MedicineActive Not Recruiting
Baltimore, Maryland, United States
Hope NeurologyActive Not Recruiting
Knoxville, Tennessee, United States
Instituto de Neurologia de CuritibaActive Not Recruiting
Curitiba, Paraná, Brazil
Centro de Pesquisas ClinicasActive Not Recruiting
São Paulo, São Paulo, Brazil
Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.Recruiting
Guadalajara, Jalisco, Mexico
Inovacion y Desarrollo en ciencias de la saludActive Not Recruiting
Mexico City, Mexico CITY (federal District), Mexico
Nottingham University Hospitals NHS TrustActive Not Recruiting
Nottingham, United Kingdom
Morriston HospitalActive Not Recruiting
Swansea, United Kingdom