Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

Official Title

A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

Keywords

Colitis, Ulcerative Colitis Ulcer Golimumab Guselkumab JNJ-78934804

Eligibility

You can join if…

Open to people ages 18-65

  • 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

You CAN'T join if...

  • 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

  • University of California San Diego Health
    La Jolla California 92037 United States
  • Northshore Gastroenterology Research, LLC
    San Diego California 92103-2120 United States
  • Southern California Research Center
    Coronado California 92118 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT05242484
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 550 study participants
Last Updated