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

Clinical Trial ID: NCT04033445

Description

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

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.


Criteria

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

  • Start Date

    2019-09-26

  • Last Updated

    2020-02-18

  • Sponsor

    Janssen Research & Development, LLC

  • Condition Name

    Ulcerative Colitis

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