BENITIONSClinical Trial Intelligence

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)

3期 进行中(已停止招募) NCT04548999

适应症Multiple Sclerosis
分期3期
申办方Hoffmann-La Roche
状态进行中(已停止招募)
受试者人数769 人
干预(药物)Ocrelizumab, Ocrelizumab, Antihistamine, Methylprednisolone
开始日期2020年12月3日
完成日期2025年6月30日
结果公布日2026年7月24日

摘要

This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with PPMS, in comparison to the approved 600 milligrams (mg) dose of ocrelizumab.

Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12)

Up to approximately 4.5 years · weeks

Ocrelizumab 600 mg158.7 weeks
Ocrelizumab 1200 mg or 1800 mg169.0 weeks
p-value0.6376
Hazard Ratio (HR)0.95 (95% CI 0.76–1.18)

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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。