Open Actively Recruiting

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

About

Brief 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).

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II/III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

Join this Trial

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Study Stats
Protocol No.
20-000484
Category
Gastroenterology
Contact
William Swearingen
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04033445
For detailed technical eligibility, visit ClinicalTrials.gov.