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

Purpose

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.

Condition

  • Crohn's Disease

Eligibility

Eligible Ages
Between 2 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion 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 or equal to [>=] 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) within 1 month of receiving study intervention at Week 0 - Participants must have a history of inadequate response, loss of response, or intolerance to immunomodulators (6-MP, AZA, or MTX), oral or IV corticosteroids, or biologic therapy/JAK inhibitor therapy; OR have a history of corticosteroid dependence; OR have a history of inadequate response to exclusive enteral nutrition (EEN)

Exclusion Criteria

  • 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Open-label induction phase: Guselkumab Intravenously (IV) 		Participants will receive guselkumab dose IV based on their body weight during the 12-week open-label induction phase.
  • Drug: Guselkumab
    Guselkumab will be administered intravenously.
    Other names:
    • CNTO1959
    • TREMFYA
Experimental
Open-label induction phase: Guselkumab Subcutaneously (SC) 		Participants will receive guselkumab dose SC based on their body weight during the 12-week open-label induction phase.
  • Drug: Guselkumab
    Guselkumab will be administered subcutaneously.
    Other names:
    • CNTO1959
    • TREMFYA
Experimental
Double-blind maintenance phase: Guselkumab SC Dose Regimen 1 		At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 1 SC based on their body weight up to Week 48.
  • Drug: Guselkumab
    Guselkumab will be administered subcutaneously.
    Other names:
    • CNTO1959
    • TREMFYA
Experimental
Double-blind Maintenance Phase: Guselkumab SC Dose Regimen 2 		At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 2 SC based on their body weight up to Week 48.
  • Drug: Guselkumab
    Guselkumab will be administered subcutaneously.
    Other names:
    • CNTO1959
    • TREMFYA
Experimental
Open-label maintenance phase: Guselkumab SC 		Week 12 non-responders will not be randomized and will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 48.
  • Drug: Guselkumab
    Guselkumab will be administered subcutaneously.
    Other names:
    • CNTO1959
    • TREMFYA

Recruiting Locations

Cedars Sinai Medical Center
Los Angeles, California 90048

Connecticut Children's Medical Center
Hartford, Connecticut 06106

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

Riley Hospital for Children
Indianapolis, Indiana 46202-5225

Boston Childrens Hospital
Boston, Massachusetts 02115

Goryeb Children's Hospital
Morristown, New Jersey 07960

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

Icahn School of Medicine at Mount Sinai
New York, New York 10029

Columbia University Medical Center
New York, New York 10032

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104

Cook Childrens Medical Center
Fort Worth, Texas 76104

University of Vermont Medical Center
Colchester, Vermont 05446

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com