Living with Crohn's disease can be incredibly tough, with symptoms that affect daily life. A new drug called guselkumab is currently being tested to see how well it can help people with this condition. The study, which includes over 1,400 participants, is designed to evaluate both the effectiveness and safety of guselkumab over a 48-week period. It consists of three parts: one phase focuses on finding the right doses, while the other two confirm how well the drug works in real-world scenarios. Researchers will measure how much the drug helps reduce symptoms and improve overall health. Participants who complete the studies may have the chance to continue in a long-term follow-up. If guselkumab proves effective, it could provide a new option for those struggling with the challenges of Crohn's disease, potentially improving their quality of life.
Can a new drug bring relief to those suffering from Crohn's disease?
Plain Language Summary
What this means for you:
Guselkumab may offer a new hope for managing Crohn's disease effectively. What this means for you:
Guselkumab may offer a new hope for managing Crohn's disease 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