Gastroenterology
PHASE3
● Phase III
Guselkumab Shows Promise in Crohn's Disease: Phase 3 Study Results
ClinicalTrials.gov
Published March 28, 2026
Janssen Research & Development, LLC
NCT03466411 ↗
This ongoing Phase 2/3 study investigates the efficacy and safety of guselkumab in patients with moderately to severely active Crohn's disease. The study includes three separate trials: GALAXI 1, a 48-week Phase 2 dose-ranging study, and GALAXI 2 and GALAXI 3, both 48-week Phase 3 confirmatory studies. The primary outcomes focus on changes in the Crohn's Disease Activity Index (CDAI) score at Week 12 for GALAXI 1, and the percentage of participants achieving both clinical response at Week 12 and clinical remission at Week 48 for GALAXI 2. Additionally, GALAXI 2 evaluates the percentage of participants achieving both clinical response at Week 12 and endoscopic response at Week 48. A total of 1409 participants have been enrolled, with the study's primary completion date noted as October 20, 2023. The study is sponsored by Janssen Research & Development, LLC, and results are expected to be posted by May 7, 2025. Participants completing the 48-week studies may enter a long-term extension phase. The study assesses efficacy, pharmacokinetics, biomarkers, and safety, aiming to identify optimal induction and maintenance dosing regimens.
AI Accuracy Review: 9/10
· Auto-published
Living with Crohn's disease can be challenging, and finding effective treatments is crucial for improving quality of life. This study evaluates guselkumab, a new treatment, to see how well it works and how safe it is for people with moderately to severely active Crohn's disease. The research includes three separate studies over 48 weeks, focusing on different aspects of treatment effectiveness. The first study will measure changes in disease activity after 12 weeks, while the other two will look at both clinical response and remission rates after 12 and 48 weeks. With 1,409 participants involved, this research aims to provide valuable insights into how guselkumab can help manage symptoms and potentially lead to longer-term improvements. If proven effective, this treatment could be a game-changer for many individuals battling this condition.
What this means for you: Guselkumab may offer new hope for managing Crohn's disease symptoms effectively.
View Original Abstract ↓
Status: ACTIVE_NOT_RECRUITING | Phase: PHASE2/PHASE3
Condition(s): Crohn's Disease
Intervention(s): Guselkumab Dose 1 (DRUG), Guselkumab Dose 2 (DRUG), Guselkumab Dose 3 (DRUG), Guselkumab Dose 4 (DRUG), Guselkumab Dose 5 (DRUG)
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.
Detailed: This program consists of 3 separate studies: a 48-week Phase 2 dose-ranging study (GALAXI 1) and two 48-week Phase 3 confirmatory studies (GALAXI 2 and GALAXI 3). In Phase 2, safety and efficacy of guselkumab dose regimens will be evaluated to support the selection of induction and maintenance dose regimens for confirmatory evaluation in Phase 3. Participants who complete the 48-week Phase 2 or Phase 3 studies may be eligible to enter the long term extension (LTE). Throughout the 3 studies, efficacy, pharmacokinetic, biomarkers, and safety will be assessed.
Primary Outcome(s): GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12; Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48; Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48
Enrollment: 1409 (ACTUAL)
Lead Sponsor: Janssen Research & Development, LLC
Start: 2018-04-13 | Primary Completion: 2023-10-20
Results posted: 2025-05-07
