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

Description

The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.

Conditions

Crohn's Disease

Talk to us

Study Overview

On this page

Study Details

Study overview

The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.

A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn's Disease

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

Condition
Crohn's Disease
Intervention / Treatment

-

Contacts and Locations

Hartford

Connecticut Children's Medical Center, Hartford, Connecticut, United States, 06106

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Atlanta

Children's Center for Digestive Health Care, Atlanta, Georgia, United States, 30342

Indianapolis

Riley Hospital for Children, Indianapolis, Indiana, United States, 46202-5225

New York

Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center, New York, New York, United States, 10021-5663

New York

Columbia University Medical Center, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participants must have a diagnosis of Crohn's Disease (CD) or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
  • * Participants must have moderately to severely active CD (as defined by a baseline Pediatric Crohn's Disease Activity Index \[PCDAI\] score greater than \[\>\] 30)
  • * Participants must have endoscopy with evidence of active CD defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score greater than or equal to (\>=) 6 (or \>=4 for participants with isolated ileal disease) during screening into this study
  • * Participants must have a prior or current CD medication history that includes either inadequate response, loss of response to or failure to tolerate current treatment immunomodulators or with oral or intravenously (IV) corticosteroids or have received biologic therapy/JAK inhibitor for the treatment of CD and have a documented history of inadequate response, loss of response (LOR), or intolerance to the biologic therapy/JAK inhibitor
  • * Participants has complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery.
  • * Participants must not have an abscess
  • * Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline

Ages Eligible for Study

2 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

2028-04-27