Status:
ACTIVE_NOT_RECRUITING
A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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.
Detailed Description
This program consists of 3 separate studies: a 48-week Phase 2 dose-ranging study (GALAXI 1) and two 48-week Phase 3 confirmatory studies (GALAXI 2 and GALAXI 3). In Phase 2, safety and efficacy of gu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2028
Estimated Enrollment :
1409 Patients enrolled
Trial Details
Trial ID
NCT03466411
Start Date
April 13 2018
End Date
January 28 2028
Last Update
December 22 2025
Active Locations (576)
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1
Digestive Health Specialists of the Southeast
Dothan, Alabama, United States, 36305
2
Internal Medicine Center
Mobile, Alabama, United States, 36693
3
University of Arizona
Tucson, Arizona, United States, 85724
4
Advanced Research Center Inc
Anaheim, California, United States, 92805