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

NCT05242484

Active Not RecruitingPhase 2

Sponsor: Janssen Research & Development, LLC

Conditions: Colitis, Ulcerative

Interventions: Guselkumab, Golimumab, JNJ-78934804, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
* Moderately to severely active UC as assessed by the modified Mayo score
* Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity
* If female and of childbearing potential, must meet the contraception and reproduction requirements

Exclusion Criteria:

* Has severe extensive colitis as defined in the protocol
* Extent of inflammatory disease limited to the rectum
* Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)
* Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer
* Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)

Locations (403)

Arcadia, California, United States
Coronado, California, United States
Lancaster, California, United States
Los Angeles, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Hamden, Connecticut, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Coconut Creek, Florida, United States
Kissimmee, Florida, United States
Kissimmee, Florida, United States
Lakewood Rch, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Orlando, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Macon, Georgia, United States
Marietta, Georgia, United States
Marietta, Georgia, United States
Roswell, Georgia, United States
Idaho Falls, Idaho, United States
Indianapolis, Indiana, United States
New Albany, Indiana, United States
Crestview Hills, Kentucky, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
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