A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

Summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

Timeline

Start

2022-01-19

Primary completion

2023-07-04

Completion

2028-10-30

Outcome

Met primary endpoint

registry Placebo vs Combined: Guselkumab 400 mg; p < 0.001; Adjusted treatment difference:percentage 34.9 (95% CI 25.1 to 44.6) NCT05197049 ↗

registry Placebo vs Combined: Guselkumab 400 mg; p < 0.001; Adjusted treatment difference:percentage 19.9 (95% CI 10.2 to 29.6) NCT05197049 ↗

Publications

• Hart A, Panaccione R, Steinwurz F, Danese S, Hisamatsu T, Cao Q, Ritter T, Seidler U, Olurinde M, Vetter ML, Yee J, Yang Z, Wang Y, Johanns J, Han C, Sahoo A, Terry NA, Sands BE, D'Haens G; GRAVITI Study Group. Efficacy and Safety of Guselkumab Subcutaneous Induction and Maintenance in Participants With Moderately to Severely Active Crohn's Disease: Results From the Phase 3 GRAVITI Study. Gastroenterology. 2025 Aug;169(2):308-325. doi: 10.1053/j.gastro.2025.02.033. Epub 2025 Mar 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Guselkumab	Monoclonal antibody	100 mg	Subcutaneous
Subject	Guselkumab	Monoclonal antibody	200 mg	Subcutaneous

Indications