Ocrelizumab for relapsing and primary progressive multiple sclerosis

A Multicenter, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Chinese Patients With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis

This trial will test if ocrelizumab helps people with relapsing MS and will characterize its effects in Chinese patients with primary progressive MS.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Hoffmann-La Roche (industry)
• Drugs / interventions: rituximab, ocrelizumab, belimumab, ofatumumab
• Locations: 17 sites (Nanchang, Jiangxi and 16 other locations)
• Trial ID: NCT07483450 on ClinicalTrials.gov

What this trial studies

This is a phase 4 interventional trial of ocrelizumab enrolling people with relapsing MS and a cohort of Chinese participants with primary progressive MS. Participants must meet the 2017 McDonald Criteria, have brain MRI findings consistent with MS, and fall within specified EDSS ranges (0–5.5 for RMS; 3.0–6.5 for PPMS). The study will collect efficacy, safety, pharmacokinetic, and pharmacodynamic data, with MRI monitoring and mandatory pre-medications for infusions. It is sponsored by Hoffmann-La Roche and conducted at major hospitals in China.

Who should consider this trial

Good fit: Adults diagnosed with relapsing MS or primary progressive MS by the 2017 McDonald Criteria who have MRI evidence of MS and meet the study EDSS ranges (0–5.5 for RMS; 3.0–6.5 for PPMS) and can undergo MRI and required pre‑medications.

Not a fit: People with non-active secondary progressive MS, a history of PML, contraindications to MRI or required pre‑medications, other neurologic disorders that could confound MS assessments, or those excluded by the study's disease-duration rules may not benefit or be eligible.

Why it matters

Potential benefit: If successful, ocrelizumab could reduce relapses and slow disability in people with relapsing MS and provide data to guide its use in Chinese patients with primary progressive MS.

How similar studies have performed: Large international trials have already shown ocrelizumab reduces relapses in relapsing MS and can slow disability progression in primary progressive MS.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Where this trial is running

Nanchang, Jiangxi and 16 other locations

• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (RECRUITING)
• Peking Union Medical College Hospital — Beijing, China (RECRUITING)
• Peking University First Hospital — Beijing, China (RECRUITING)
• Beijing Hospital of Ministry of Health — Beijing, China (RECRUITING)
• Xiangya Hospital Central South University — Changsha, China (RECRUITING)
• West China Hospital of Sichuan University — Chengdu, China (RECRUITING)
• The First Affiliated Hospital, Chongqing Medical University — Chongqing, China (RECRUITING)
• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, China (RECRUITING)
• The Third Affiliated Hospital of Sun Yat-Sen University — Guangzhou, China (RECRUITING)
• The First Affiliated Hospital of College of Medicine, Zhejiang University — Hangzhou, China (RECRUITING)
• Inner Mongolia Autonomous Region People's Hospital — Hohhot, China (RECRUITING)
• Lanzhou University Second Hospital — Lanzhou, China (RECRUITING)
• The First Hospital of China Medical University — Shenyang, China (RECRUITING)
• The Second Hospital of Hebei Medical University — Shijiazhuang, China (ACTIVE_NOT_RECRUITING)
• 1st Affiliated Hospital of Shanxi Medical University — Taiyuan, China (RECRUITING)
• Xinjiang People Hospital — Ürümqi, China (RECRUITING)
• Tongji Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, China (RECRUITING)

Study contacts

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

Conditions: Relapsing Multiple Sclerosis, Primary Progressive Multiple Sclerosis