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

NCT04033445

Active Not RecruitingPhase 2, Phase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Ulcerative Colitis

Interventions: Placebo, Guselkumab

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (392)
  • Lancaster, California, United States
  • Los Angeles, California, United States
  • Colorado Springs, Colorado, United States
  • Gainesville, Florida, United States
  • Gainesville, Florida, United States
  • Hialeah, Florida, United States
  • Jacksonville, Florida, United States
  • Kissimmee, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • Orlando, Florida, United States
  • Pinellas Park, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Decatur, Georgia, United States
  • Macon, Georgia, United States
  • Chicago, Illinois, United States
  • Pratt, Kansas, United States
  • Crestview Hills, Kentucky, United States
  • Springfield, Massachusetts, United States
  • Clinton Township, Michigan, United States
  • Farmington Hills, Michigan, United States
  • Grand Rapids, Michigan, United States
  • Kansas City, Missouri, United States
  • St Louis, Missouri, United States
  • Las Vegas, Nevada, United States
  • + 362 more on CT.gov