Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD
Dates
study started
estimated completion

Description

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).

Official Title

A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

Details

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.

Keywords

Ulcerative Colitis Colitis Colitis, Ulcerative Ulcer Guselkumab Induction Study 2: Guselkumab IV

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UC San Diego withdrawn
    La Jolla California 92093 United States
  • UCLA accepting new patients
    Los Angeles California 90095 United States
  • San Francisco Research Institute withdrawn
    San Francisco California 94127 United States
  • Care Access Research, Berkeley withdrawn
    Berkeley California 94705 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT04033445
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 1000 study participants
Last Updated