A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
Public ClinicalTrials.gov record NCT05528510. 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 3, 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 Ulcerative Colitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).
Study identification
- NCT ID
- NCT05528510
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 418 participants
Conditions and interventions
Conditions
Interventions
- Guselkumab Dose 1 Drug
- Guselkumab Dose 2 Drug
- Guselkumab Dose 3 Drug
- Placebo Other
Drug · Other
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 13, 2022 (Actual)
- Primary completion
- Apr 2, 2024 (Actual)
- Completion
- Oct 6, 2028 (Estimated)
- Last update posted
- Sep 28, 2026
2022 – 2028
United States locations
- U.S. sites
- 32
- U.S. states
- 15
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Solutions of Arizona | Litchfield Park | Arizona | 85340 | — |
| Om Research LLC 1 | Apple Valley | California | 92307 | — |
| Om Research LLC | Lancaster | California | 93534 | — |
| Medical Associates Research Group, Inc. | San Diego | California | 92123 | — |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | — |
| Gastro Florida | Clearwater | Florida | 33762 | — |
| I.H.S. Health. LLC | Kissimmee | Florida | 34741 | — |
| Columbus Clinical Services LLC | Miami | Florida | 33125 | — |
| Vista Health Research, LLC | Miami | Florida | 33176 | — |
| Orlando Health | Orlando | Florida | 32806 | — |
| Theia Clincial Research, LLC | Temple Terrace | Florida | 34209 | — |
| Digestive Healthcare of Georgia, P.C | Atlanta | Georgia | 30309 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | — |
| Gastroenterology Associates of Central GA | Macon | Georgia | 31201 | — |
| Cotton O'Neil Digestive Health Center | Topeka | Kansas | 66606 | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | — |
| Detroit Clinical Research Center | Farmington Hills | Michigan | 48334 | — |
| Smart Medical Research | Hollis | New York | 11423 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599-7080 | — |
| Peters Medical Research | High Point | North Carolina | 27260 | — |
| Dayton Gastroenterology, Inc | Dayton | Ohio | 45415 | — |
| Gastro Intestinal Research Institute of Northern Ohio LLC | Westlake | Ohio | 44145 | — |
| Allegheny General Hospital of Research | Pittsburgh | Pennsylvania | 15224 | — |
| Frontier Clinical Research | Uniontown | Pennsylvania | 15401 | — |
| Gastroenterology Associates of Orangeburg, SC | Orangeburg | South Carolina | 29118 | — |
| Southern Star Research Institute, LLC | San Antonio | Texas | 78229 | — |
| UT Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | — |
| Victoria Gastroenterology | Victoria | Texas | 77407 | — |
| Care Access Research, Ogden | Ogden | Utah | 84403 | — |
| Gastroenterology Associates | Salt Lake City | Utah | 84124 | — |
| 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 204 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05528510, 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
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05528510 live on ClinicalTrials.gov.