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.
Can a new treatment help people with Crohn's disease feel better and stay better?
Plain Language Summary
What this means for you:
Guselkumab may offer new hope for managing Crohn's disease symptoms effectively. 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