ClinicalTrials.gov record
A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
ClinicalTrials.gov ID: NCT03466411
Public ClinicalTrials.gov record NCT03466411. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03466411
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 1,409 participants
Conditions and interventions
Conditions
Interventions
- Guselkumab Dose 1 Drug
- Guselkumab Dose 2 Drug
- Guselkumab Dose 3 Drug
- Guselkumab Dose 4 Drug
- Guselkumab Dose 5 Drug
- Guselkumab Drug
- Ustekinumab Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 13, 2018 (Actual)
- Primary completion
- Oct 20, 2023 (Actual)
- Completion
- Jan 28, 2028 (Estimated)
- Last update posted
- Sep 28, 2026
2018 – 2028
United States locations
- U.S. sites
- 109
- U.S. states
- 25
- U.S. cities
- 86
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Digestive Health Specialists of the Southeast | Dothan | Alabama | 36305 | — |
| Internal Medicine Center | Mobile | Alabama | 36693 | — |
| University of Arizona | Tucson | Arizona | 85724 | — |
| Advanced Research Center Inc | Anaheim | California | 92805 | — |
| Paul Wallace MD | Beverly Hills | California | 90211 | — |
| University Of California San Diego | La Jolla | California | 92093 | — |
| Om Research LLC | Lancaster | California | 93534 | — |
| Allameh Medical Corp | Mission Viejo | California | 92691 | — |
| United Gastroenterologists | Murrieta | California | 92563 | — |
| Clinnova Research | Orange | California | 92868 | — |
| Inland Empire Liver Foundation | Rialto | California | 91106 | — |
| UC Davis Medical Center | Sacramento | California | 95817 | — |
| Clinical Applications Laboratories, Inc | San Diego | California | 91941 | — |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80920 | — |
| Pioneer Research Solutions Inc. | Coconut Creek | Florida | 33066 | — |
| InvesClinic, LLC | Fort Lauderdale | Florida | 33308 | — |
| Harmony Medical Research Institute, Inc. | Hialeah | Florida | 33016 | — |
| Elite Research Network - Nature Coast Clinical Research, LLC | Inverness | Florida | 34452 | — |
| SIH Research | Kissimmee | Florida | 34759 | — |
| Auzmer Research | Lakeland | Florida | 33813 | — |
| Florida Research Center Inc. | Lakewood Rch | Florida | 34211 | — |
| Homestead Associates in Research Inc | Miami | Florida | 33032 | — |
| Community Research Foundation, Inc. | Miami | Florida | 33155 | — |
| Sanchez Clinical Research, Inc | Miami | Florida | 33157-6575 | — |
| Visionary Investigators Network | Miami | Florida | 33180 | — |
| Gastroenterology Group Of Naples | Naples | Florida | 34102 | — |
| Florida Hospital | Orlando | Florida | 32803 | — |
| Omega Research Consultants | Orlando | Florida | 32808 | — |
| Care Access Research, Orlando | Orlando | Florida | 32825 | — |
| Synexus Clinical Research US Inc 1 | Pinellas Park | Florida | 33781 | — |
| Central Florida Internists | Saint Cloud | Florida | 34769 | — |
| Synergy Clinical Research | St. Petersburg | Florida | 33705 | — |
| Theia Clincial Research, LLC | St. Petersburg | Florida | 33709 | — |
| Clinical Research of West Florida | Tampa | Florida | 33603 | — |
| GCP Clinical Research | Tampa | Florida | 33609 | — |
| Florida Hospital Tampa | Tampa | Florida | 33613 | — |
| Alliance Clinical Research | Tampa | Florida | 33615 | — |
| Cleveland Clinic Florida | Weston | Florida | 33331 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30224 | — |
| Morehouse School of Medicine | Atlanta | Georgia | 30310 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Atlanta Center For Gastroenterology | Decatur | Georgia | 30033 | — |
| Gastroenterology Consultants | Roswell | Georgia | 30076 | — |
| Atlanta Gastroenterology Specialists PC | Suwanee | Georgia | 30024 | — |
| Carle Foundation Hospital | Urbana | Illinois | 61801 | — |
| IU Health University Hospital | Indianapolis | Indiana | 46202 | — |
| BVL Clinical Research | Leawood | Kansas | 66211 | — |
| Health Science Research Center | Pratt | Kansas | 67124 | — |
| Cotton O'Neil Digestive Health Center | Topeka | Kansas | 66606 | — |
| Gastroenterology Associates | Baton Rouge | Louisiana | 70809 | — |
| Gastroenterology Clinic of Acadiana | Lafayette | Louisiana | 70503 | — |
| Tandem Clinical Research | Marrero | Louisiana | 70072 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| DelRicht Research | New Orleans | Louisiana | 70124 | — |
| LSUHSC Shreveport Feist-Weiller Cancer Center | Shreveport | Louisiana | 71103 | — |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71105 | — |
| Woodholme Gastroenterology Associates | Baltimore | Maryland | 21208 | — |
| Digestive Health Specialists PC | Chelmsford | Massachusetts | 01824 | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | — |
| Huron Gastroenterology Associates Center for Digestive Care | Ypsilanti | Michigan | 48197 | — |
| Las Vegas Medical Research | Las Vegas | Nevada | 89113 | — |
| Atlantic Digestive Health Institute/ Atlantic IBD Center | Morristown | New Jersey | 07960 | — |
| A1 Clinical Research | Jackson Heights | New York | 11372 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| New York Gastroenterology Associates | New York | New York | 10028 | — |
| Care Access Research | New York | New York | 10065 | — |
| NYU Langone Medical Center | New York | New York | 11021 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Syracuse VA Medical Center | Syracuse | New York | 13210 | — |
| Asheville Gastroenterology Associates | Asheville | North Carolina | 28801 | — |
| University North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Charlotte Gastroenterology and Hepatology, PLLC | Charlotte | North Carolina | 28207 | — |
| Onsite Clinical Solutions | Charlotte | North Carolina | 28277 | — |
| Cumberland Research Associates | Fayetteville | North Carolina | 28304 | — |
| Care Access Research, Kinston | Kinston | North Carolina | 28501 | — |
| Clinical Trials of America | Mount Airy | North Carolina | 27030 | — |
| PMG Research of Winston-Salem | Winston-Salem | North Carolina | 27103 | — |
| Clinical Inquest Center, LTD | Beavercreek | Ohio | 45432 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Synexus Clinical Research US Inc 2 | Columbus | Ohio | 43212 | — |
| Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | 44060 | — |
| Southwoods Health | Poland | Ohio | 44514 | — |
| Northshore Gastroenterology Research, LLC | Westlake | Ohio | 44145 | — |
| Integris Baptist Office | Oklahoma City | Oklahoma | 73112 | — |
| US Digestive Health | Wyomissing | Pennsylvania | 19610 | — |
| Synexus Clinical Research US Inc | Anderson | South Carolina | 29621-2062 | — |
| Gastroenterology Associates P.A. | Greenville | South Carolina | 29615 | — |
| Memorial Health Care System | Chattanooga | Tennessee | 37404 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| Tennessee State University | Johnson | Tennessee | 37614-1700 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212-1610 | — |
| DHAT Research Institute | Garland | Texas | 75044 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| Houston Digestive Diseases Consultants | Houston | Texas | 77074 | — |
| CliniCore Houston | Houston | Texas | 77079 | — |
| Caprock Gastro Research | Lubbock | Texas | 79424 | — |
| Gastroenterology Clinic Of San Antonio P A | San Antonio | Texas | 78229 | — |
| Gastroenterology Research of America, LLC | San Antonio | Texas | 78229 | — |
| UT Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| Texas Digestive Disease Consultants | Southlake | Texas | 76092 | — |
| Texas Gastroenterology Associates - Research | Spring | Texas | 77386 | — |
| Baylor Scott and White Research Institute | Temple | Texas | 76508 | — |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | — |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | 23320 | — |
| Center for Gastrointestinal Health | Petersburg | Virginia | 23805 | — |
| Gastroenterology Consultants of Southwest Virginia | Roanoke | Virginia | 24014-1372 | — |
| Northwest Gastroenterology Associates - USA | Bellevue | Washington | 98004 | — |
| Washington Gastroenterology, PLLC | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 470 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03466411, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 28, 2026 · Synced Oct 25, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03466411 live on ClinicalTrials.gov.