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

第2/3相実施中（募集終了） NCT04033445

対象疾患	Ulcerative Colitis
相	第2/3相
スポンサー	Janssen Research & Development, LLC
ステータス	実施中（募集終了）
参加者数	1,064 名
介入（薬剤）	Guselkumab
開始日	2019年9月26日
完了日	2023年9月19日
結果公開日	2024年11月18日

概要

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)

BENITIONS で見る ClinicalTrials.gov の原文を見る

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すべての治験

このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。

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