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

  • STATUS
    Recruiting
  • participants needed
    25
  • sponsor
    Janssen Pharmaceutical K.K.
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Updated on 16 February 2024
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colitis
endoscopy
guselkumab
crohn's disease
ileocolitis
ileitis
stomach pain

Summary

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

Details
Condition Inflammatory bowel disease, Inflammatory bowel disease, Crohn's Disease, Crohn's Disease, crohn's disease (pediatric), crohn's disease (pediatric)
Age 18years - 100years
Treatment Guselkumab
Clinical Study IdentifierNCT04397263
SponsorJanssen Pharmaceutical K.K.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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