NCT07483450

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
10mo left

Started Jul 2025

Geographic Reach
1 country

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Jul 2025Apr 2027

Study Start

First participant enrolled

July 4, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2027

Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

1.7 years

First QC Date

March 16, 2026

Last Update Submit

May 22, 2026

Conditions

Relapsing Multiple SclerosisPrimary 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

  • +13 more secondary outcomes

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

OcrelizumabDRUG

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

Also known as: OCREVUS®, RO4964913
PPMS CohortRMS Cohort

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330209, China

RECRUITING

Peking Union Medical College Hospital

Beijing, 100032, China

RECRUITING

Peking University First Hospital

Beijing, 100034, China

RECRUITING

Beijing Hospital of Ministry of Health

Beijing, 100730, China

RECRUITING

Xiangya Hospital Central South University

Changsha, 410008, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, 610041, China

RECRUITING

The First Affiliated Hospital, Chongqing Medical University

Chongqing, 400016, China

RECRUITING

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, 510080, China

RECRUITING

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, 510630, China

RECRUITING

The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, 310003, China

RECRUITING

Inner Mongolia Autonomous Region People's Hospital

Hohhot, 010011, China

RECRUITING

Lanzhou University Second Hospital

Lanzhou, 730030, China

RECRUITING

The First Hospital of China Medical University

Shenyang, DUMMY_VALUE, China

RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, 050000, China

ACTIVE NOT RECRUITING

1st Affiliated Hospital of Shanxi Medical University

Taiyuan, 030000, China

RECRUITING

Xinjiang People Hospital

Ürümqi, 830000, China

RECRUITING

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430030, China

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: YN44938 https://forpatients.roche.com/

CONTACT

888-662-6728global-roche-genentech-trials@gene.com

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)

March 12, 2027

Study Completion (Estimated)

April 23, 2027

Last Updated

May 27, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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

Locations

CN(17)