Last updated on December 2019

A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Brief description of study

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

Detailed Study 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.

Clinical Study Identifier: NCT03466411

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Meir Medical Center

Kfar Saba, Israel
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Chaim Sheba Medical Center

Ramat Gan, Israel
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Shaare Zedek Medical Center

Jerusalem, Israel
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Rabin Med Ctr Beilinson Hosp

Petah Tikva, Israel
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