NCT07483450Active, not recruitingPhase 4
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Relapsing Multiple Sclerosis 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
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 16 Mar 2026
- Start date
- 4 Jul 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Multiple sclerosis
- NCT number
- NCT07483450
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 60
- From 4 Jul 2025 to the primary completion date, 31 Dec 2027
- 17 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to mandatory pre-medications (i.e., corticosteroids and antihistamines)
- Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
- 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
Other illness
- 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)
- 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
- Known history of human immunodeficiency virus (HIV) infection
- Positive screening tests for hepatitis B virus (HBV) and/or hepatitis C virus (HCV)
Other
- Diagnosis of PPMS or non-active secondary progressive multiple sclerosis (SPMS) (only for RMS cohort)
- Inability to complete an MRI scan or contraindication to Gd administration
- Lack of peripheral venous access
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Hospital of Ministry of Health Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The First Affiliated Hospital, Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| The Third Affiliated Hospital of Sun Yat-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| the First Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital of College of Medicine,Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Inner Mongolia Autonomous Region People's Hospital Coordinator of this site? Confirm its status | Hohhot | China | Unknown status |
| Lanzhou University Second Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| The First Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| The Second Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| 1st Affiliated Hospital of Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Xinjiang People Hospital Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.