A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
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.
Timeline
- Start
- 2018-04-13
- Primary completion
- 2023-10-20
- Completion
- 2028-01-28
Outcome
Met primary endpoint
registry p <0.001; Least Square (LS) Mean Difference 124.2 (95% CI 89.8 to 158.7); Mixed Model for Repeated Measure NCT03466411 ↗
registry p <0.001; Adjusted treatment difference 38.1 (95% CI 27.3 to 48.9); Mantel Haenszel NCT03466411 ↗
registry p <0.001; Adjusted treatment difference 33.7 (95% CI 24.1 to 43.2); Mantel Haenszel NCT03466411 ↗
registry p <0.001; Adjusted treatment difference 34.2 (95% CI 23.2 to 45.3); Mantel Haenszel NCT03466411 ↗
registry p <0.001; Adjusted treatment difference 27.9 (95% CI 18.7 to 37.1); Mantel Haenszel NCT03466411 ↗
registry p <0.001; Adjusted treatment difference 25.1 (95% CI 14.1 to 36.2); Mantel Haenszel NCT03466411 ↗
registry p <0.001; Adjusted treatment difference 27.7 (95% CI 19.3 to 36.1); Mantel Haenszel NCT03466411 ↗
registry p <0.001; Adjusted treatment difference 31.2 (95% CI 21.1 to 41.3); Mantel Haenszel NCT03466411 ↗
registry p <0.001; Adjusted treatment difference 22.1 (95% CI 12.2 to 31.9); Mantel Haenszel NCT03466411 ↗
Publications
- Afzali A, Danese S, Panaccione R, Rubin DT, Sands BE, Reinisch W, Panes J, Van Rampelbergh R, Terry NA, Salese L, Vetter ML, Yee J, Corbett C, van Duijnhoven W, Hisamatsu T, Andrews JM, D'Haens GR; GALAXI 1 investigators. Five-year efficacy and safety of guselkumab for moderately to severely active Crohn's disease: Results from the phase 2 GALAXI 1 trial. Inflamm Bowel Dis. 2026 May 1:izag055. doi: 10.1093/ibd/izag055. Online ahead of print.
- Panaccione R, Feagan BG, Afzali A, Rubin DT, Reinisch W, Panes J, Danese S, Hisamatsu T, Terry NA, Salese L, Van Rampelbergh R, Sahoo A, Vetter ML, Yee J, Han C, Frustaci ME, Wan KYY, Yang Z, Johanns J, Andrews JM, D'Haens GR, Sands BE; GALAXI 2 & 3 Study Group. Efficacy and safety of intravenous induction and subcutaneous maintenance therapy with guselkumab for patients with Crohn's disease (GALAXI-2 and GALAXI-3): 48-week results from two phase 3, randomised, placebo and active comparator-controlled, double-blind, triple-dummy trials. Lancet. 2025 Jul 26;406(10501):358-375. doi: 10.1016/S0140-6736(25)00681-6. Epub 2025 Jul 17.
- Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4.
- Danese S, Panaccione R, Feagan BG, Afzali A, Rubin DT, Sands BE, Reinisch W, Panes J, Sahoo A, Terry NA, Chan D, Han C, Frustaci ME, Yang Z, Sandborn WJ, Hisamatsu T, Andrews JM, D'Haens GR; GALAXI-1 Study Group. Efficacy and safety of 48 weeks of guselkumab for patients with Crohn's disease: maintenance results from the phase 2, randomised, double-blind GALAXI-1 trial. Lancet Gastroenterol Hepatol. 2024 Feb;9(2):133-146. doi: 10.1016/S2468-1253(23)00318-7. Epub 2023 Dec 14.
- Sandborn WJ, D'Haens GR, Reinisch W, Panes J, Chan D, Gonzalez S, Weisel K, Germinaro M, Frustaci ME, Yang Z, Adedokun OJ, Han C, Panaccione R, Hisamatsu T, Danese S, Rubin DT, Sands BE, Afzali A, Andrews JM, Feagan BG; GALAXI-1 Investigators. Guselkumab for the Treatment of Crohn's Disease: Induction Results From the Phase 2 GALAXI-1 Study. Gastroenterology. 2022 May;162(6):1650-1664.e8. doi: 10.1053/j.gastro.2022.01.047. Epub 2022 Feb 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Guselkumab | Monoclonal antibody | 100 mg | Intravenous |
| Subject | Guselkumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Ustekinumab | Monoclonal antibody | 90 mg | Intravenous |