A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis

NCT07483450 | Active Not Recruiting Phase 4

• 1 other identifier: YN44938
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 17

Brief Summary

The main purpose of this study is to evaluate the efficacy of ocrelizumab in participants with relapsing multiple sclerosis (RMS) and to characterize the ocrelizumab pharmacodynamic (PD) profile in Chinese participants with primary progressive multiple sclerosis (PPMS).

Conditions

Relapsing Multiple Sclerosis; Primary Progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• RMS Cohort: Annualized Protocol-defined Relapse Rate

  Up to approximately 1.6 years

• PPMS Cohort: B-cell Levels in Blood

  Up to Week 48

• PPMS Cohort: Percentage of Participants Achieving Cluster of Differentiation 19 (CD19+) B-cell Levels of <10 Cells/Microliter (μL) at Week 48

  At Week 48

Secondary Outcomes (18)

• RMS Cohort: Percentage of Participants Who Have No Evidence of Disease Activity (NEDA3) During a 48-week Period

  Up to Week 48

• RMS Cohort: Percentage of Relapse-free Participants by Week 48

  Up to Week 48

• RMS Cohort: Percentage of Participants Who Have NEDA3 During a 24-week Period

  Up to Week 24

• RMS Cohort: Total Number of T1 Gadolinium (Gd)-enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI)

  Up to Week 48

• RMS Cohort: Total Number of New or Enlarging T2 Hyperintense Lesions as Detected by Brain MRI

  Up to Week 48

Study Arms (2)

RMS Cohort

EXPERIMENTAL

Participants with RMS will receive ocrelizumab, 300 milligrams (mg), intravenous (IV) infusions on Days 1 and 15 of Cycle 1 and thereafter as a single infusion of 600 mg, IV, for all subsequent cycles every 24 weeks (Q24W) (1 Cycle=24 weeks).

Drug: Ocrelizumab

PPMS Cohort

EXPERIMENTAL

Participants with PPMS will receive ocrelizumab, 300 mg, IV infusions on Days 1 and 15 of Cycle 1 and thereafter as a single infusion of 600 mg, IV, at Week 24 (1 Cycle=24 weeks).

Drug: Ocrelizumab

Interventions

Ocrelizumab DRUG

Ocrelizumab will be administered as per the schedule specified in the respective arms.

Also known as: OCREVUS®, RO4964913

PPMS Cohort; RMS Cohort

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of RMS/PPMS in accordance with the revised 2017 McDonald Criteria
• EDSS score from 0-5.5 (RMS) or 3.0-6.5 (PPMS), inclusive, at screening and baseline
• Documented MRI of brain with abnormalities consistent with MS before screening

You may not qualify if:

• Diagnosis of PPMS or non-active secondary progressive multiple sclerosis (SPMS) (only for RMS cohort)
• History of relapsing remitting multiple sclerosis (RRMS) or SPMS at screening (only for PPMS cohort)
• Disease duration of more than 10 years in participants with an EDSS ≤ 2.0 at screening (only for RMS cohort)
• History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
• Inability to complete an MRI scan or contraindication to Gd administration
• Contraindications to mandatory pre-medications (i.e., corticosteroids and antihistamines)
• Known presence of other neurologic disorders if they could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study
• Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
• Known history of human immunodeficiency virus (HIV) infection
• Lack of peripheral venous access
• Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab), unless the last infusion was at least 6 months prior to screening
• Positive screening tests for hepatitis B virus (HBV) and/or hepatitis C virus (HCV)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (17)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330209, China

Location

Peking Union Medical College Hospital

Beijing, 100032, China

Location

Peking University First Hospital

Beijing, 100034, China

Location

Beijing Hospital of Ministry of Health

Beijing, 100730, China

Location

Xiangya Hospital Central South University

Changsha, 410008, China

Location

West China Hospital of Sichuan University

Chengdu, 610041, China

Location

The First Affiliated Hospital, Chongqing Medical University

Chongqing, 400016, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, 510080, China

Location

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, 510630, China

Location

The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, 310003, China

Location

Inner Mongolia Autonomous Region People's Hospital

Hohhot, 010011, China

Location

Lanzhou University Second Hospital

Lanzhou, 730030, China

Location

The First Hospital of China Medical University

Shenyang, DUMMY_VALUE, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, 050000, China

Location

1st Affiliated Hospital of Shanxi Medical University

Taiyuan, 030000, China

Location

Xinjiang People Hospital

Ürümqi, 830000, China

Location

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430030, China

Location

Related Links

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MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

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; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: July 4, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (17)