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)

NCT07503340 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: BA458412025-524164-37-00
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Relapsing-remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Peak Concentration (Cmax) of Ocrelizumab After the First SC Injection

  Up to 24 weeks

• Area Under the Concentration-time Curve Over a Dosing Interval (AUCtau) After the First SC Injection of Ocrelizumab

  Up to 24 weeks

Secondary Outcomes (5)

• Incidence and Nature of Adverse Events (AEs)

  Up to 260 weeks

• Percentage of Participants Who Discontinued Study Treatment due to AEs

  Up to 96 weeks

• Levels of Cluster of Differentiation 19+ (CD19+) B-cell Count in Blood

  Up to 260 weeks

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

  Up to 260 weeks

• Number of Participants With ADAs to rHuPH20

  Up to 260 weeks

Study Arms (1)

Ocrelizumab

EXPERIMENTAL

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

Interventions

Ocrelizumab co-formulated with rHuPH20 DRUG

Ocrelizumab co-formulated with rHuPH20 will be administered as per the schedule specified in the arm.

Also known as: RO4964913; Ocrevus

Ocrelizumab

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: BA45841 https://forpatients.roche.com/

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2031
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share