A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS) (Operetta III)

May 22, 2026 updated by: Hoffmann-La Roche

An Open-label Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis

The main purpose of this study is to evaluate the pharmacokinetics (PK) of ocrelizumab administered subcutaneously (SC) in children and adolescents aged 10 to <18 years with RRMS. The study consists of a 48-week treatment period, an Optional Ocrelizumab Extension (OOE) period of at least 48 weeks, and Safety Follow-up (SFU) for 104 weeks.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

For participants who are under 18 years old at the end of the OOE period, it may be extended until the participant turns 18 years old (or as required per local regulation) or until commercial ocrelizumab intravenous (IV) is approved for children and adolescents and available in the country for these participants, whichever occurs first.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children and adolescents from 10 years to less than 18 years of age, at the time of baseline visit
  • Body weight ≥25 kg
  • Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, or McDonald criteria 2017 or 2024
  • Neurologic stability for at least 30 days prior to screening, and between screening and baseline
  • Expanded Disability Status Scale (EDSS) score, 0-5.5, at screening
  • Must have received all childhood required vaccinations as per local/national recommendations for childhood vaccination against infectious diseases

Exclusion Criteria:

  • Participants who are positive for aquaporin 4 (AQP4) or myelin oligodendrocyte glycoprotein (MOG) antibody are not eligible to participate in the study
  • Any known presence or suspicion of other neurologic disorders that may mimic multiple sclerosis (MS)
  • History or known presence of recurrent or chronic infection (e.g., human immunodeficiency virus [HIV], syphilis, tuberculosis [TB])
  • Contraindications against SC injections or other conditions not suitable for SC injections, e.g., extremely thin SC fat layer
  • History of a severe allergic or anaphylactic reaction to humanized or murine monoclonal antibody or known hypersensitivity to any component of ocrelizumab solution
  • Contraindications to mandatory premedications (i.e., corticosteroids and histamines), including closed-angle glaucoma for antihistamines
  • Participants who have previously received treatment with B cell-targeted therapies, including ocrelizumab
  • Any previous treatment with alemtuzumab, anti-CD4, cladribine, mitoxantrone, daclizumab, laquinimod, total body irradiation, or bone marrow transplantation
  • Treatment with any investigational agent within 24 weeks of screening or 5 half-lives, whichever is longer (or longer if indicated by the PD action of the drug)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ocrelizumab
Participants will receive ocrelizumab co-formulated with recombinant human hyaluronidase (rHuPH20), 480 milligrams (mg) (body weight <35 kilograms [kg]) or 920 mg (body weight ≥35 kg), as a SC injection, every 6 months during the 48-week treatment and OOE periods.
Drug: Ocrelizumab co-formulated with rHuPH20
Ocrelizumab co-formulated with rHuPH20 will be administered as per the schedule specified in the arm.
Other Names:
  • RO4964913; Ocrevus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak Concentration (Cmax) of Ocrelizumab After the First SC Injection
Time Frame: Up to 24 weeks
Up to 24 weeks
Area Under the Concentration-time Curve Over a Dosing Interval (AUCtau) After the First SC Injection of Ocrelizumab
Time Frame: Up to 24 weeks
Up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and Nature of Adverse Events (AEs)
Time Frame: Up to 260 weeks
Up to 260 weeks
Percentage of Participants Who Discontinued Study Treatment due to AEs
Time Frame: Up to 96 weeks
Up to 96 weeks
Levels of Cluster of Differentiation 19+ (CD19+) B-cell Count in Blood
Time Frame: Up to 260 weeks
Up to 260 weeks
Number of Participants With Anti-drug Antibodies (ADAs) to Ocrelizumab
Time Frame: Up to 260 weeks
Up to 260 weeks
Number of Participants With ADAs to rHuPH20
Time Frame: Up to 260 weeks
Up to 260 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2031

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA45841
  • 2025-524164-37-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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