ClinicalTrials.gov record
Active, not recruiting Phase 3 Interventional Results available

A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

ClinicalTrials.gov ID: NCT05197049

Public ClinicalTrials.gov record NCT05197049. 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.

ClinicalTrials.gov public records Last synced May 10, 2026, 9:42 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Crohn's Disease

Study identification

NCT ID
NCT05197049
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Janssen Research & Development, LLC
Industry
Enrollment
350 participants

Conditions and interventions

Conditions

Interventions

  • Guselkumab Dose 1 Drug
  • Guselkumab Dose 2 Drug
  • Guselkumab Dose 3 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
Jan 18, 2022
Primary completion
Jul 3, 2023
Completion
Oct 29, 2028
Last update posted
May 7, 2026

2022 – 2028

United States locations

U.S. sites
77
U.S. states
27
U.S. cities
68
Facility City State ZIP Site status
Digestive Health Specialists of the Southeast Dothan Alabama 36305
Advanced Gastro P.C Chandler Arizona 85224-1636
Reliance Research Scottsdale Arizona 85260
Moore Clinical Trials, LLC Little Rock Arkansas 72205-6414
Central Arkansas Veterans Healthcare System Little Rock Arkansas 72223
Om Research LLC 1 Lancaster California 93534
Om Research LLC Lancaster California 93534
United Gastroenterologists Los Alamitos California 90720
Paul Wallace MD Los Angeles California 90048
Clinnova Research Orange California 92868
Digestive System Healthcare Pasadena California 77505-3950
Northshore Gastroenterology Research, LLC San Diego California 92103-2120
Clinical Applications Laboratories, Inc San Diego California 92103
Santa Maria Gastroenterology Santa Maria California 93454
Clinical Research of California Walnut Creek California 94598
Amel Med LLC Research Grand Junction Colorado 81505-1027
Western Connecticut Health Network/Danbury Hospital Danbury Connecticut 06810
Gastroenterology Associates of SW Florida Clearwater Florida 33762-5323
Pioneer Research Solutions Inc. Coconut Creek Florida 33066
Omega Research Consultants DeBary Florida 32713
Harmony Medical Research Institute, Inc. Hialeah Florida 33016
Central Florida Gastro Research Kissimmee Florida 34741
Community Research Foundation, Inc. Miami Florida 33155
Gastroenterology Group Of Naples Naples Florida 34102
Center for Digestive Health Orlando Florida 32803-1853
Central Florida Internists Orlando Florida 32819
Synergy Clinical Research St. Petersburg Florida 33705
Atlanta Gastroenterology Specialists, PC Atlanta Georgia 30224
Agile Clinical Research Trials, LLC Atlanta Georgia 30328
Atlanta Center For Gastroenterology Decatur Georgia 30033
Gastroenterolgy Associates of Central GA Macon Georgia 31201
Gastroenterology Consultants Roswell Georgia 30076-4943
USF Asthma, Allergy, Immunology Clinical Research Unit Boise Idaho 83706
Grand Teton Research Group, PLLC Idaho Falls Idaho 83404
Lemah Creek Clinical Research Oakbrook Terrace Illinois 60618
University of Kansas Medical Center Kansas City Kansas 66103-2937
BVL Clinical Research Leawood Kansas 66211
Cotton O'Neil Digestive Health Center Topeka Kansas 66606
Tri-State Gastroenterology Assoc Crestview Hills Kentucky 41017
Tandem Clinical Research Marrero Louisiana 70072
Institute for Digestive Health and Liver Disease Baltimore Maryland 21202-2102
Woodholme Gastroenterology Associates Glen Burnie Maryland 21061
Digestive Health Specialists PC Chelmsford Massachusetts 01824
FC Research, LLC South Dartmouth Massachusetts 02747
Clinical Research Institute of Michigan, LLC Chesterfield Michigan 48047
Detroit Clinical Research Center Livonia Michigan 48152
University of Mississippi Medical Center Jackson Mississippi 39216
SUNY Downstate Medical Center Brooklyn New York 11203
Smart Medical Research Jackson Heights New York 11372
Crystal Run Healthcare LLP Middletown New York 10941
New York Gastroenterology Associates New York New York 10075
DiGiovanna Institute for Medical Education & Research North Massapequa New York 11758
A1 Clinical Network Queens New York 11375
Carolinas Medical Center Charlotte North Carolina 28207
Onsite Clinical Solutions Charlotte North Carolina 28277
Carolina Research Greenville North Carolina 27834
Gastroenterology Associates of the Piedmont, P.A. Winston-Salem North Carolina 27103
Central Ohio Endoscopy Center LLC Columbus Ohio 43214
Dayton Gastroenterology, Inc Dayton Ohio 45440
Great Lakes Gastroenterology Mentor Ohio 44060
Oklahoma University Health Science Center Oklahoma City Oklahoma 73104
Integris Baptist Office Oklahoma City Oklahoma 73112
Central Sooner Research Oklahoma City Oklahoma 73120
Essential Medical Research Tulsa Oklahoma 74137-7061
The Oregon Clinic Portland Oregon 97220-9428
Frontier Clinical Research Smithfield Pennsylvania 15478
Gastroenterology Associates P.A. Greenville South Carolina 29615
Carolina Health Specialists Myrtle Beach South Carolina 29572
West Texas Clinical Research Lubbock Texas 79424
Victoria Gastroenterology Richmond Texas 77407
Gastroenterology Clinic Of San Antonio P A San Antonio Texas 78229
Wellness Clinical Research San Antonio Texas 78232
Texas Digestive Disease Consultants Southlake Texas 76092
Digestive Health Specialists of Tyler Tyler Texas 75701
Care Access Research- Salt Lake City Salt Lake City Utah 84124
Burke Internal Medicine and Research Burke Virginia 22015
Gastroenterology Associates of Tidewater Chesapeake Virginia 23320

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 268 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05197049, 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 May 7, 2026 · Synced May 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05197049 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →