Status:
COMPLETED
A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Crohns Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety of Guselkumab in participants with Crohn's disease.
Eligibility Criteria
Inclusion
- Have Crohn's Disease (CD) or fistulizing CD 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 components of stool frequency (SF), and abdominal pain (AP) scores, and endoscopic evidence
- 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
- Has complications of CD, 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 time frame as specified in the protocol
- Prior exposure to p40 inhibitors or p19 inhibitors
- Any medical contraindications preventing study participation
Key Trial Info
Start Date :
June 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2025
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04397263
Start Date
June 10 2020
End Date
September 12 2025
Last Update
October 17 2025
Active Locations (25)
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1
KOKIKAI Tokatsu Tsujinaka Hospital
Abiko, Japan, 270-1168
2
Institute of Science Tokyo Hospital
Bunkyō City, Japan, 113 8519
3
Hitachi General Hospital
Hitachi, Japan, 317-0077
4
Asahikawa Medical University Hospital
Hokkaido, Japan, 078 8510