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

NCT05528510

Active Not RecruitingPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Colitis, Ulcerative

Interventions: Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3, Placebo

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

The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo 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:

* Signed informed consent form
* 18 years of age or older
* Documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening
* Moderately to severely active UC as per the modified Mayo score
* Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol

Exclusion Criteria:

* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease
* Surgery within 8 weeks before screening or planned surgery during the study that may confound the evaluation of benefit from study intervention
* Receiving prohibited medications and treatments
* UC limited to the rectum only
* Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) corona virus disease (COVID-19) infection
Locations (236)
  • Litchfield Park, Arizona, United States
  • Apple Valley, California, United States
  • Lancaster, California, United States
  • San Diego, California, United States
  • Colorado Springs, Colorado, United States
  • Clearwater, Florida, United States
  • Kissimmee, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • Temple Terrace, Florida, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Macon, Georgia, United States
  • Topeka, Kansas, United States
  • Chesterfield, Michigan, United States
  • Farmington Hills, Michigan, United States
  • Hollis, New York, United States
  • Chapel Hill, North Carolina, United States
  • High Point, North Carolina, United States
  • Dayton, Ohio, United States
  • Westlake, Ohio, United States
  • Pittsburgh, Pennsylvania, United States
  • Uniontown, Pennsylvania, United States
  • Orangeburg, South Carolina, United States
  • San Antonio, Texas, United States
  • San Antonio, Texas, United States
  • Tyler, Texas, United States
  • Victoria, Texas, United States
  • Ogden, Utah, United States
  • + 206 more on CT.gov