A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

2/3상 진행 중(모집 완료) NCT03466411

대상 질환	Crohn's Disease
임상 단계	2/3상
스폰서	Janssen Research & Development, LLC
상태	진행 중(모집 완료)
참여자 수	1,409 명
중재(약물)	Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3, Guselkumab Dose 4, Guselkumab Dose 5
시작일	2018년 4월 13일
완료일	2023년 10월 20일
결과 공개일	2025년 5월 7일

요약

The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.

GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12

Baseline and Week 12 · Units on a scale

GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w	-143.7 ± 96.58 Units on a scale
GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w	-139.2 ± 100.71 Units on a scale
GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w	-159.8 ± 110.52 Units on a scale
GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w	-34.4 ± 104.85 Units on a scale

p-value	<0.001
Least Square (LS) Mean Difference	124.2 (95% CI 89.8–158.7)

Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48

Weeks 48 · Percentage of participants

GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w	54.8 Percentage of participants
GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w	49.0 Percentage of participants
GALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w	11.8 Percentage of participants

p-value	<0.001
Adjusted treatment difference	38.1 (95% CI 27.3–48.9)

Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48

Weeks 48 · Percentage of participants

GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w	38.4 Percentage of participants
GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w	39.2 Percentage of participants
GALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w	5.3 Percentage of participants

p-value	<0.001
Adjusted treatment difference	33.7 (95% CI 24.1–43.2)

BENITIONS에서 보기 ClinicalTrials.gov 원문 보기

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PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease — Celularity Incorporated
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A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Par — Pfizer

전체 임상

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