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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Colitis, Ulcerative

In brief

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).

Key facts

Study ID

NCT05528510

Run by

Janssen Research & Development, LLC

People needed

418

Starts

2022-09-13

Expected to finish

2028-10-06

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent form
• 18 years of age or older
• Documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening
• Moderately to severely active UC as per the modified Mayo score
• Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol

You may not qualify if…

• Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease
• Surgery within 8 weeks before screening or planned surgery during the study that may confound the evaluation of benefit from study intervention
• Receiving prohibited medications and treatments
• UC limited to the rectum only
• Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) corona virus disease (COVID-19) infection

Where it is running

• Om Research LLC 1 — Apple Valley, California, United States
• Om Research LLC — Lancaster, California, United States
• Medical Associates Research Group, Inc. — San Diego, California, United States
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• Gastro Florida — Clearwater, Florida, United States
• I.H.S. Health. LLC — Kissimmee, Florida, United States
• Columbus Clinical Services LLC — Miami, Florida, United States
• Vista Health Research, LLC — Miami, Florida, United States
• Orlando Health — Orlando, Florida, United States
• Theia Clincial Research, LLC — Temple Terrace, Florida, United States
• Digestive Healthcare of Georgia, P.C — Atlanta, Georgia, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Gastroenterology Associates of Central GA — Macon, Georgia, United States
• Cotton O'Neil Digestive Health Center — Topeka, Kansas, United States
• Clinical Research Institute of Michigan, LLC — Chesterfield, Michigan, United States
• Detroit Clinical Research Center — Farmington Hills, Michigan, United States
• Smart Medical Research — Hollis, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Peters Medical Research — High Point, North Carolina, United States
• Dayton Gastroenterology, Inc — Dayton, Ohio, United States
• Gastro Intestinal Research Institute of Northern Ohio LLC — Westlake, Ohio, United States
• Allegheny General Hospital of Research — Pittsburgh, Pennsylvania, United States
• Frontier Clinical Research — Uniontown, Pennsylvania, United States
• Gastroenterology Associates of Orangeburg, SC — Orangeburg, South Carolina, United States
• Research Solutions of Arizona — Litchfield Park, Arizona, United States

Full record on ClinicalTrials.gov

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