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

Phase 2/3 Active, not recruiting NCT03466411

Condition	Crohn's Disease
Phase	Phase 2/3
Sponsor	Janssen Research & Development, LLC
Status	Active, not recruiting
Enrollment	1,409 participants
Interventions	Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3, Guselkumab Dose 4, Guselkumab Dose 5
Start date	Apr 13, 2018
Completion date	Oct 20, 2023
Results posted	May 7, 2025

Summary

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)

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Act — Janssen Research & Development, LLC
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn' — Janssen Research & Development, LLC
A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Partic — Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease — Celularity Incorporated
Loss of RESponse to Ustekinumab Treated by Dose Escalation — Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Par — Pfizer

All trials

This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.

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