A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

2/3期进行中（已停止招募） NCT04033445

适应症	Ulcerative Colitis
分期	2/3期
申办方	Janssen Research & Development, LLC
状态	进行中（已停止招募）
受试者人数	1,064 人
干预（药物）	Guselkumab
开始日期	2019年9月26日
完成日期	2023年9月19日
结果公布日	2024年11月18日

摘要

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).

Induction Study 1: Percentage of Participants With Clinical Response at Week I-12

At Week I-12 · Percentage of participants

IS-1: Period 1: Placebo IV at Weeks I-0, I-4 and I-8	27.6 Percentage of participants
IS-1: Period 1: Guselkumab 200 mg IV at Weeks I-0, I-4 and I-8	61.4 Percentage of participants
IS-1: Period 1: Guselkumab 400 mg IV at Weeks I-0, I-4 and I-8	60.7 Percentage of participants

p-value	< 0.001
Adjusted treatment difference	33.6 (95% CI 20.9–46.3)

Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12

At Week I-12 · Percentage of participants

IS-2: Period 1: Placebo IV at Weeks I-0, I-4 and I-8	7.9 Percentage of participants
IS-2: Period 1: Guselkumab 200 mg IV at Weeks I-0, I-4 and I-8	22.6 Percentage of participants

p-value	< 0.001
Adjusted treatment difference	14.9 (95% CI 9.9–19.9)

Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44

At Week M-44 · Percentage of participants

MS: Randomized: Placebo SC Every 4 Weeks (q4w)	18.9 Percentage of participants
MS: Randomized: Guselkumab 100 mg SC q8w	45.2 Percentage of participants
MS: Randomized: Guselkumab 200 mg SC q4w	50.0 Percentage of participants

p-value	< 0.001
Adjusted treatment difference	25.2 (95% CI 16.4–33.9)

在 BENITIONS 中查看查看 ClinicalTrials.gov 原文

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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。

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