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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 RecruitingPhase 4

Sponsor: Hoffmann-La Roche

Conditions: Relapsing Multiple Sclerosis, Primary Progressive Multiple Sclerosis

Interventions: Ocrelizumab

Countries: China

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 overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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)

Locations (17)

Nanchang, Jiangxi, China
Beijing, China
Beijing, China
Beijing, China
Changsha, China
Chengdu, China
Chongqing, China
Guangzhou, China
Guangzhou, China
Hangzhou, China
Hohhot, China
Lanzhou, China
Shenyang, China
Shijiazhuang, China
Taiyuan, China
Ürümqi, China
Wuhan, China