drugset / Trial / NCT05528510

A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Phase 3 Active not recruiting 418 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).

Timeline

Start: 2022-09-13
Primary completion: 2024-04-02
Completion: 2028-10-06

Outcome

Met primary endpoint

paper A significantly greater proportion of participants receiving guselkumab 400 mg induction versus placebo had clinical remission at week 12 PMID 41544637 ↗

registry NUMBER Combined Guselkumab 400 mg: 27.6 (22.4 to 32.8) Percentage of participants NCT05528510 ↗

registry analysis (superiority test); Placebo; p <0.001; Adjusted Treatment Difference 21.1 (95% CI 14.5 to 27.6); Mantel Haenszel NCT05528510 ↗

release “The Phase 3 ASTRO study met its primary endpoint, achieving a statistically significant and clinically meaningful results for clinical remission at Week 12” jnj.com ↗

Publications

Long M, Allegretti JR, Danese S, Germinaro M, Baker T, Alvarez Y, Kavalam M, Han C, Jorgens S, Jiang L, Zhang H, Hisamatsu T, Rubin DT, Peyrin-Biroulet L; ASTRO Study Group. Efficacy and safety of subcutaneous guselkumab induction therapy in participants with moderately to severely active ulcerative colitis (ASTRO): a double-blind, treat-through, randomised, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2026 Apr;11(4):284-298. doi: 10.1016/S2468-1253(25)00322-X. Epub 2026 Jan 13.

Drugs

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