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Clinical Trial Summary

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


Clinical Trial Description

This program consists of 3 separate studies: a 48-week Phase 2 dose-ranging study (GALAXI 1) and two 48-week Phase 3 confirmatory studies (GALAXI 2 and GALAXI 3). In Phase 2, safety and efficacy of guselkumab dose regimens will be evaluated to support the selection of induction and maintenance dose regimens for confirmatory evaluation in Phase 3. Participants who complete the 48-week Phase 2 or Phase 3 studies may be eligible to enter the long term extension (LTE). Throughout the 3 studies, efficacy, pharmacokinetic, biomarkers, and safety will be assessed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03466411
Study type Interventional
Source Janssen Research & Development, LLC
Contact Study Contact
Phone 844-434-4210
Email JNJ.CT@sylogent.com
Status Recruiting
Phase Phase 3
Start date April 13, 2018
Completion date October 23, 2024

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