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

Running, not enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).

Key facts

Study ID

NCT04033445

Run by

Janssen Research & Development, LLC

People needed

1064

Starts

2019-09-26

Expected to finish

2027-09-29

Last updated by the study team

2026-07-29

Who can join

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

You may qualify if…

• Documented diagnosis of ulcerative colitis (UC)
• Moderately to severely active UC, defined by modified Mayo score
• Demonstrated inadequate response or intolerance to medical therapies specified in the protocol
• Screening laboratory test results within the parameters specified in the protocol

You may not qualify if…

• Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease
• UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon
• Presence of a stoma
• Presence or history of a fistula
• Receiving prohibited medications and/or treatment

Where it is running

• UCLA — Los Angeles, California, United States
• Peak Gastroenterology Associates 1 — Colorado Springs, Colorado, United States
• Florida Research Network, LLC — Gainesville, Florida, United States
• University of Florida Health Jacksonville — Gainesville, Florida, United States
• Harmony Medical Research Institute, Inc. — Hialeah, Florida, United States
• UF Health Jacksonville Gastroenterology Emerson — Jacksonville, 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
• Care Access Research, Orlando — Orlando, Florida, United States
• Synexus Clinical Research US Inc 2 — Pinellas Park, Florida, United States
• Univ. of South Florida Med. Group — Tampa, Florida, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Morehouse School of Medicine — Atlanta, Georgia, United States
• The Emory Clinic — Atlanta, Georgia, United States
• Atlanta Gastroenterology Associates 1 — Atlanta, Georgia, United States
• Atlanta Center For Gastroenterology — Decatur, Georgia, United States
• Gastroenterolgy Associates of Central GA — Macon, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Health Science Research Center — Pratt, Kansas, United States
• Tri-State Gastroenterology Assoc — Crestview Hills, Kentucky, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Clinical Research Institute of Michigan, LLC — Clinton Township, Michigan, United States
• Om Research LLC — Lancaster, California, United States

Full record on ClinicalTrials.gov

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