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A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

NCT03466411

Active Not RecruitingPhase 2, Phase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Crohn's Disease

Interventions: Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3, Guselkumab Dose 4, Guselkumab Dose 5

Countries: United States, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada

The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) 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:

* Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
* Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
* Have screening laboratory test results within the protocol specified parameters
* A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
* Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

Exclusion Criteria:

* Current diagnosis of ulcerative colitis or indeterminate colitis
* Has complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation
* Unstable doses of concomitant Crohn's disease therapy
* Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol
* Any medical contraindications preventing study participation
Locations (579)
  • Dothan, Alabama, United States
  • Mobile, Alabama, United States
  • Tucson, Arizona, United States
  • Anaheim, California, United States
  • Beverly Hills, California, United States
  • La Jolla, California, United States
  • Lancaster, California, United States
  • Mission Viejo, California, United States
  • Murrieta, California, United States
  • Orange, California, United States
  • Rialto, California, United States
  • Sacramento, California, United States
  • San Diego, California, United States
  • Colorado Springs, Colorado, United States
  • Coconut Creek, Florida, United States
  • Fort Lauderdale, Florida, United States
  • Hialeah, Florida, United States
  • Inverness, Florida, United States
  • Kissimmee, Florida, United States
  • Lakeland, Florida, United States
  • Lakewood Rch, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Naples, Florida, United States
  • Orlando, Florida, United States
  • Orlando, Florida, United States
  • Orlando, Florida, United States
  • Pinellas Park, Florida, United States
  • + 549 more on CT.gov