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A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease
A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

NCT05197049

Active Not RecruitingPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Crohn Disease

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

Countries: United States, Australia, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Croatia

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Diagnosis of Crohn's disease (CD) of at least 3 months in duration
* Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD).
* Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

Exclusion Criteria:

* Current diagnosis of ulcerative colitis or indeterminate colitis
* Complications of Crohn's disease that require surgical intervention or confound efficacy assessments
* Unstable doses of concomitant Crohn's disease therapy
Locations (345)
  • Dothan, Alabama, United States
  • Chandler, Arizona, United States
  • Scottsdale, Arizona, United States
  • Little Rock, Arkansas, United States
  • Little Rock, Arkansas, United States
  • Lancaster, California, United States
  • Lancaster, California, United States
  • Los Alamitos, California, United States
  • Los Angeles, California, United States
  • Orange, California, United States
  • Pasadena, California, United States
  • San Diego, California, United States
  • San Diego, California, United States
  • Santa Maria, California, United States
  • Walnut Creek, California, United States
  • Grand Junction, Colorado, United States
  • Danbury, Connecticut, United States
  • Clearwater, Florida, United States
  • Coconut Creek, Florida, United States
  • DeBary, Florida, United States
  • Hialeah, Florida, United States
  • Kissimmee, Florida, United States
  • Miami, Florida, United States
  • Naples, Florida, United States
  • Orlando, Florida, United States
  • Orlando, Florida, United States
  • St. Petersburg, Florida, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Decatur, Georgia, United States
  • + 315 more on CT.gov