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
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Beijing Hospital of Ministry of Health
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Xiangya Hospital Central South University
RECRUITING
Changsha
West China Hospital of Sichuan University
RECRUITING
Chengdu
The First Affiliated Hospital, Chongqing Medical University
RECRUITING
Chongqing
The First Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
The Third Affiliated Hospital of Sun Yat-Sen University
RECRUITING
Guangzhou
The First Affiliated Hospital of College of Medicine, Zhejiang University
RECRUITING
Hangzhou
Inner Mongolia Autonomous Region People's Hospital
RECRUITING
Hohhot
Lanzhou University Second Hospital
RECRUITING
Lanzhou
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The First Hospital of China Medical University
RECRUITING
Shenyang
The Second Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
1st Affiliated Hospital of Shanxi Medical University
RECRUITING
Taiyuan
Xinjiang People Hospital
RECRUITING
Ürümqi
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Reference Study ID Number: YN44938 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728
Time Frame
Start Date: 2025-07-04
Estimated Completion Date: 2027-04-23
Participants
Target number of participants: 60
Treatments
Experimental: RMS Cohort
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).
Experimental: PPMS Cohort
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).
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche