BENITIONSClinical Trial Intelligence

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis

3期 进行中(已停止招募) NCT04221477

适应症Lupus Nephritis
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271 人
干预(药物)Obinutuzumab, MMF, Prednisone, Methylprednisolone, Acetaminophen
开始日期2020年8月10日
完成日期2024年8月15日
结果公布日2025年11月6日

摘要

This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in participants with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.

Percentage of Participants With Complete Renal Response (CRR)

At Week 76 · percentage of participants

Obinutuzumab46.4 percentage of participants
Placebo33.1 percentage of participants
p-value0.0232
Adjusted Difference13.40 (95% CI 1.95–24.84)

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

同一适应症的其他试验

全部试验

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。