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A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.
Official title: A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1409
Start Date
2018-04-13
Completion Date
2028-01-28
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Guselkumab Dose 1
Guselkumab will be administered by IV infusion.
Guselkumab Dose 2
Guselkumab will be administered by SC injection.
Guselkumab Dose 3
Guselkumab will be administered by IV infusion.
Guselkumab Dose 4
Guselkumab will be administered by IV infusion.
Guselkumab Dose 5
Guselkumab will be by SC injection.
Guselkumab
Guselkumab will be administered by IV infusion and SC injection.
Ustekinumab
Ustekinumab will be administered by IV infusion and SC injection.
Placebo
Placebo will be administered as IV infusion.
Locations (579)
Digestive Health Specialists of the Southeast
Dothan, Alabama, United States
Internal Medicine Center
Mobile, Alabama, United States
University of Arizona
Tucson, Arizona, United States
Advanced Research Center Inc
Anaheim, California, United States
Paul Wallace MD
Beverly Hills, California, United States
University Of California San Diego
La Jolla, California, United States
Om Research LLC
Lancaster, California, United States
Allameh Medical Corp
Mission Viejo, California, United States
United Gastroenterologists
Murrieta, California, United States
Clinnova Research
Orange, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
UC Davis Medical Center
Sacramento, California, United States
Clinical Applications Laboratories, Inc
San Diego, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Pioneer Research Solutions Inc.
Coconut Creek, Florida, United States
InvesClinic, LLC
Fort Lauderdale, Florida, United States
Harmony Medical Research Institute, Inc.
Hialeah, Florida, United States
Elite Research Network - Nature Coast Clinical Research, LLC
Inverness, Florida, United States
SIH Research
Kissimmee, Florida, United States
Auzmer Research
Lakeland, Florida, United States
Florida Research Center Inc.
Lakewood Rch, Florida, United States
Homestead Associates in Research Inc
Miami, Florida, United States
Community Research Foundation, Inc.
Miami, Florida, United States
Sanchez Clinical Research, Inc
Miami, Florida, United States
Visionary Investigators Network
Miami, Florida, United States
Gastroenterology Group Of Naples
Naples, Florida, United States
Florida Hospital
Orlando, Florida, United States
Omega Research Consultants
Orlando, Florida, United States
Care Access Research, Orlando
Orlando, Florida, United States
Synexus Clinical Research US Inc 1
Pinellas Park, Florida, United States
Central Florida Internists
Saint Cloud, Florida, United States
Synergy Clinical Research
St. Petersburg, Florida, United States
Theia Clincial Research, LLC
St. Petersburg, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
GCP Clinical Research
Tampa, Florida, United States
Florida Hospital Tampa
Tampa, Florida, United States
Alliance Clinical Research
Tampa, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Morehouse School of Medicine
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Atlanta Center For Gastroenterology
Decatur, Georgia, United States
Gastroenterology Consultants
Roswell, Georgia, United States
Atlanta Gastroenterology Specialists PC
Suwanee, Georgia, United States
Carle Foundation Hospital
Urbana, Illinois, United States
IU Health University Hospital
Indianapolis, Indiana, United States
BVL Clinical Research
Leawood, Kansas, United States
Health Science Research Center
Pratt, Kansas, United States
Cotton O'Neil Digestive Health Center
Topeka, Kansas, United States
Gastroenterology Associates
Baton Rouge, Louisiana, United States
Gastroenterology Clinic of Acadiana
Lafayette, Louisiana, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
DelRicht Research
New Orleans, Louisiana, United States
LSUHSC Shreveport Feist-Weiller Cancer Center
Shreveport, Louisiana, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Woodholme Gastroenterology Associates
Baltimore, Maryland, United States
Digestive Health Specialists PC
Chelmsford, Massachusetts, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
Huron Gastroenterology Associates Center for Digestive Care
Ypsilanti, Michigan, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
Atlantic Digestive Health Institute/ Atlantic IBD Center
Morristown, New Jersey, United States
A1 Clinical Research
Jackson Heights, New York, United States
Weill Cornell Medical College
New York, New York, United States
New York Gastroenterology Associates
New York, New York, United States
Care Access Research
New York, New York, United States
NYU Langone Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Syracuse VA Medical Center
Syracuse, New York, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, United States
University North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, United States
Onsite Clinical Solutions
Charlotte, North Carolina, United States
Cumberland Research Associates
Fayetteville, North Carolina, United States
Care Access Research, Kinston
Kinston, North Carolina, United States
Clinical Trials of America
Mount Airy, North Carolina, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States
Clinical Inquest Center, LTD
Beavercreek, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Synexus Clinical Research US Inc 2
Columbus, Ohio, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Southwoods Health
Poland, Ohio, United States
Northshore Gastroenterology Research, LLC
Westlake, Ohio, United States
Integris Baptist Office
Oklahoma City, Oklahoma, United States
US Digestive Health
Wyomissing, Pennsylvania, United States
Synexus Clinical Research US Inc
Anderson, South Carolina, United States
Gastroenterology Associates P.A.
Greenville, South Carolina, United States
Memorial Health Care System
Chattanooga, Tennessee, United States
Gastro One
Germantown, Tennessee, United States
Tennessee State University
Johnson, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
DHAT Research Institute
Garland, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Houston Digestive Diseases Consultants
Houston, Texas, United States
CliniCore Houston
Houston, Texas, United States
Caprock Gastro Research
Lubbock, Texas, United States
Gastroenterology Clinic Of San Antonio P A
San Antonio, Texas, United States
Gastroenterology Research of America, LLC
San Antonio, Texas, United States
UT Health Science Center at San Antonio
San Antonio, Texas, United States