Last updated on April 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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Austin Hospital

Heidelberg, Australia
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BelMAPE

Minsk, Belarus
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Clinical hospital Mostar

Mostar, Bosnia and Herzegovina
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Fakultni nemocnice Ostrava

Ostrava - Poruba, Czechia
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Samsung Medical Center

Seoul, Korea, Republic of
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FNsP F.D.R. Banska Bystrica

Banska Bystrica, Slovakia
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Acibadem Fulya Hospital

D:14/4 Nisantasi, Turkey
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University of Arizona

Tucson, AZ United States
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Om Research LLC

Lancaster, CA United States
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InvesClinic, LLC

Fort Lauderdale, FL United States
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SIH Research

Kissimmee, FL United States
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Florida Hospital

Orlando, FL United States
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Theia Clincial Research, LLC

Pinellas Park, FL United States
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Florida Hospital Tampa

Tampa, FL United States
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Carle Foundation Hospital

Urbana, IL United States
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Gastroenterology Associates

Baton Rouge, LA United States
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Ochsner Clinic Foundation

New Orleans, LA United States
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Louisiana Research Center, LLC

Shreveport, LA United States
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Minnesota Gastroenterology, P.A

Minneapolis, MN United States
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A1 Clinical Research

Jackson Heights, NY United States
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NYU Langone Medical Center

New York, NY United States
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Syracuse VA Medical Center

Syracuse, NY United States
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Carolina Research

Greenville, NC United States
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PMG Research of Winston-Salem

Winston-Salem, NC United States
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Aztec Clinical Research, Inc.

Channelview, TX United States
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BI Research Center

Houston, TX United States
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DHAT Research Institute

Richardson, TX United States
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Val Hansen

Bountiful, UT United States
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University of Virginia

Charlottesville, VA United States
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University of Washington

Seattle, WA United States
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Royal Adelaide Hospital

North Terrace, Australia
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Nepean Hospital

Penrith, Australia
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Mater Hospital Brisbane

South Brisbane, Australia
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Akh Wien

Wien, Austria
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GZA Ziekenhuizen

Antwerpen, Belgium
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CHU Saint-Pierre

Bruxelles, Belgium
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CHwapi

Tournai, Belgium
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Kantonalna bolnica Zenica

Zenica, Bosnia and Herzegovina
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Pesquisare Saude

Santo Andre, Brazil
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Hemomed

Sao Paulo, Brazil
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FN Hradec Kralove

Hradec Kralove, Czechia
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CHU Amiens

Amiens, France
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CHRU de Tours - Hopital Trousseau

Chambray Les Tours Centre, France
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CHU Saint-etienne

Saint Etienne, France
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CHU Rangueil

Toulouse, France
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Matsuda Hospital

Hamamatsu-Shi, Japan
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Mito Medical Center

Higashiibaraki-Gun, Japan
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Korea University Ansan Hospital

Ansan-Si, Korea, Republic of
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Dong-A University Hospital

Busan, Korea, Republic of
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Kangbuk Samsung Hospital

Seoul, Korea, Republic of
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Asan Medical Center

Seoul, Korea, Republic of
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Gangnam Severance Hospital

Seoul, Korea, Republic of
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University Clinic of Gastroenterohepatology

Skopje, Macedonia, The Former Yugoslav Republic of
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Dunedin Hospital

Dunedin, New Zealand
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Waikato Hospital

Hamilton, New Zealand
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DelRicht Research

New Orleans, LA United States
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Cumberland Research Associates

Fayetteville, NC United States
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Az Groeninge

Kortrijk, Belgium
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General City Hospital 8mi Septemvri

Skopje, Macedonia, The Former Yugoslav Republic of
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CliniCore Houston

Houston, TX United States
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Integris Baptist Office

Oklahoma City, OK United States
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Baylor College of Medicine

Houston, TX United States
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Houston Methodist Hospital

Houston, TX United States
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Victoria Gastroenterology

Victoria, TX United States
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Cleveland Clinic Florida

Weston, FL United States
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IU Health University Hospital

Indianapolis, IN United States
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Associated cardiology

Saginaw, MI United States
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LifeSpan Hospital System

Providence, RI United States
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Karolina Hospital

Mosonmagyarovár, Hungary
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Recruitment Status: Open


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