drugset

drugset / Trial / NCT05197049

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

NCT05197049 ↗

Phase 3 Active not recruiting 350 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupDouble-blindTreatment

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

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