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

2/3상 진행 중(모집 완료) NCT04033445

대상 질환	Ulcerative Colitis
임상 단계	2/3상
스폰서	Janssen Research & Development, LLC
상태	진행 중(모집 완료)
참여자 수	1,064 명
중재(약물)	Guselkumab
시작일	2019년 9월 26일
완료일	2023년 9월 19일
결과 공개일	2024년 11월 18일

요약

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)

BENITIONS에서 보기 ClinicalTrials.gov 원문 보기

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전체 임상

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