Guselkumab Shows Promise in Crohn's Disease: Phase 3 Study Results
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Key Takeaway
Evaluate guselkumab's efficacy in Crohn's disease through ongoing Phase 2/3 trials.
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.
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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
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