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

Colitis, Ulcerative Clinical Trial

Official title:
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Clinical Trial 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).

Clinical Trial Description

UC is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops ulcers. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody (mAb) that binds to human interleukin (IL)-23 with high affinity. The primary hypothesis of this study is that guselkumab SC induction is superior to placebo SC in achieving clinical remission at Week 12 among participants with moderately to severely active UC. This study consists of screening period, main treatment period, extension treatment period and safety follow-up period. Efficacy and safety assessments including adverse events, clinical laboratory tests, vital signs, and physical examinations will be performed according to the schedule of activities. The overall study duration will be up to 112 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05528510
Study type Interventional
Source Janssen Research & Development, LLC
Contact
Status Active, not recruiting
Phase Phase 3
Start date September 13, 2022
Completion date October 10, 2025
View Details
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