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

  • STATUS
    Recruiting
  • End date
    Dec 29, 2025
  • participants needed
    950
  • sponsor
    Janssen Research & Development, LLC
Updated on 19 July 2021
medical therapy

Summary

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

Description

UC is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops ulcers. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody (mAb) that binds to human interleukin (IL)-23 with high affinity. The study is designed to answer scientific questions pertaining to the efficacy and safety of guselkumab in the treatment of moderately to severely active UC. Overall, the study will evaluate long-term guselkumab treatment. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points.

Details
Condition Ulcerative Colitis, Ulcerative Colitis (Pediatric)
Treatment Placebo, Guselkumab
Clinical Study IdentifierNCT04033445
SponsorJanssen Research & Development, LLC
Last Modified on19 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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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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