A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
Public ClinicalTrials.gov record NCT04033445. 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 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
Study identification
- NCT ID
- NCT04033445
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Lead sponsor
- Janssen Research & Development, LLC
- Industry
- Enrollment
- 1,064 participants
Conditions and interventions
Conditions
Interventions
- Guselkumab 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
- Sep 25, 2019
- Primary completion
- Sep 18, 2023
- Completion
- Sep 28, 2027
- Last update posted
- May 7, 2026
2019 – 2027
United States locations
- U.S. sites
- 52
- U.S. states
- 22
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Om Research LLC | Lancaster | California | 93534 | — |
| UCLA | Los Angeles | California | 90095 | — |
| Peak Gastroenterology Associates 1 | Colorado Springs | Colorado | 80907 | — |
| Florida Research Network, LLC | Gainesville | Florida | 32605 | — |
| University of Florida Health Jacksonville | Gainesville | Florida | 32608 | — |
| Harmony Medical Research Institute, Inc. | Hialeah | Florida | 33016 | — |
| UF Health Jacksonville Gastroenterology Emerson | Jacksonville | Florida | 32209 | — |
| I.H.S. Health. LLC | Kissimmee | Florida | 34741 | — |
| Columbus Clinical Services LLC | Miami | Florida | 33125 | — |
| Vista Health Research, LLC | Miami | Florida | 33155 | — |
| Orlando Health | Orlando | Florida | 32806 | — |
| Care Access Research, Orlando | Orlando | Florida | 32825 | — |
| Synexus Clinical Research US Inc 2 | Pinellas Park | Florida | 33781 | — |
| Univ. of South Florida Med. Group | Tampa | Florida | 33606 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30224 | — |
| Morehouse School of Medicine | Atlanta | Georgia | 30310 | — |
| The Emory Clinic | Atlanta | Georgia | 30322 | — |
| Atlanta Gastroenterology Associates 1 | Atlanta | Georgia | 30342 | — |
| Atlanta Center For Gastroenterology | Decatur | Georgia | 30033 | — |
| Gastroenterolgy Associates of Central GA | Macon | Georgia | 31201 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Health Science Research Center | Pratt | Kansas | 67124 | — |
| Tri-State Gastroenterology Assoc | Crestview Hills | Kentucky | 41017 | — |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | — |
| Clinical Research Institute of Michigan, LLC | Clinton Township | Michigan | 48038 | — |
| Revive Research Institute | Farmington Hills | Michigan | 48334 | — |
| Infusion Associates | Grand Rapids | Michigan | 49525 | — |
| Mid-America Gastro-Intestinal Consultants | Kansas City | Missouri | 64111 | — |
| Barnes-jewish Hospital | St Louis | Missouri | 63108 | — |
| Las Vegas Medical Research | Las Vegas | Nevada | 89113 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | — |
| Duke University Hospital Medical Center | Raleigh | North Carolina | 27609 | — |
| Synexus Clinical Research US Inc | Columbus | Ohio | 43212 | — |
| Digestive Specialists, Inc | Springboro | Ohio | 45066 | — |
| Gastro Intestinal Research Institute of Northern Ohio LLC | Westlake | Ohio | 44145 | — |
| Care Access Research, Poland | Youngstown | Ohio | 44514 | — |
| Digestive Disease Specialists Inc | Oklahoma City | Oklahoma | 73114 | — |
| US Digestive Health | Wyomissing | Pennsylvania | 19610 | — |
| Synexus Clinical Research US Inc 1 | Anderson | South Carolina | 29621-2062 | — |
| Gastroenterology Associates of Orangeburg, SC | Orangeburg | South Carolina | 29118 | — |
| Erlanger Health System | Chattanooga | Tennessee | 37403 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Caprock Gastro Research | Lubbock | Texas | 79424 | — |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | — |
| Care Access Research, Ogden | Ogden | Utah | 84403 | — |
| Care Access Research- Salt Lake City | Salt Lake City | Utah | 84124 | — |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | 23320 | — |
| UW-Harborview Medical Center | Seattle | Washington | 98104 | — |
| Providence Medical Group | Spokane | Washington | 99208 | — |
| Velocity Clinical Research Spokane | Spokane | Washington | 99218 | — |
| Care Access Research, Casper | Casper | Wyoming | 10456 | — |
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 340 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04033445, 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 NCT04033445 live on ClinicalTrials.gov.