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Active, not recruiting Phase 3 Interventional Results available

A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

ClinicalTrials.gov ID: NCT05528510

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.

ClinicalTrials.gov public records Last synced May 19, 2026, 6:51 PM 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 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

Study identification

NCT ID
NCT05528510
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Janssen Research & Development, LLC
Industry
Enrollment
418 participants

Conditions and interventions

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 12, 2022
Primary completion
Apr 1, 2024
Completion
Oct 5, 2028
Last update posted
May 10, 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 May 10, 2026 · Synced May 19, 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 protocol, eligibility criteria, and contact information for NCT05528510 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →