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 (DUET-UC)

  • STATUS
    Recruiting
  • End date
    Sep 21, 2028
  • participants needed
    550
  • sponsor
    Janssen Research & Development, LLC
Updated on 23 October 2022
golimumab

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.

Details
Condition Colitis, Ulcerative
Treatment Placebo, Golimumab, Guselkumab, JNJ-78934804
Clinical Study IdentifierNCT05242484
SponsorJanssen Research & Development, LLC
Last Modified on23 October 2022

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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