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

  • STATUS
    Recruiting
  • End date
    Oct 15, 2024
  • participants needed
    2000
  • sponsor
    Janssen Research & Development, LLC
Updated on 5 November 2020
Investigator
The Medical Research Network, LLC
Primary Contact
Toho University Sakura Medical Center (5.3 mi away) Contact
+750 other location
endoscopy
ustekinumab
colitis
ileitis
fistulising crohn's disease
ileocolitis

Summary

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

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 guselkumab dose regimens will be evaluated to support the selection of induction and maintenance dose regimens for confirmatory evaluation in Phase 3. Participants who complete the 48-week Phase 2 or Phase 3 studies may be eligible to enter the long term extension (LTE). Throughout the 3 studies, efficacy, pharmacokinetic, biomarkers, and safety will be assessed.

Details
Treatment Placebo, Guselkumab, ustekinumab, Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3, Guselkumab Dose 4, Guselkumab Dose 5
Clinical Study IdentifierNCT03466411
SponsorJanssen Research & Development, LLC
Last Modified on5 November 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Crohn's Disease (Pediatric) or Inflammatory bowel disease or Crohn's Disease?
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
Prior exposure to p40 inhibitors or p19 inhibitors
Any medical contraindications preventing study participation
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Step 4 Get your study results

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