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

a study on Crohn's Disease Inflammatory Bowel Disease

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Details

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.

Keywords

Crohn's Disease Crohn Disease Ustekinumab Antibodies, Monoclonal Guselkumab Dose 1 Guselkumab Dose 2 Guselkumab Dose 3 Guselkumab Dose 4 Guselkumab Dose 5 Guselkumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

  • University Of California San Diego accepting new patients
    La Jolla California 92093 United States
  • Clinical Applications Laboratories, Inc accepting new patients
    San Diego California 91941 United States
  • Precision Research Institute withdrawn
    San Diego California 92114 United States
  • Precision Research Institute withdrawn
    El Cajon California 92020 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT03466411
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 1340 study participants
Last Updated
Contact us about this trial