A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Part of paid clinical trials in Oakland, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT06260163
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Colitis, Ulcerative

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.

Key Dates

Start date
Jan 19, 2024
Status verified
Jun 2026
Primary completion
Feb 10, 2027
Completion
Apr 28, 2027

Study Design

Enrollment
112 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Open-label Induction Phase: Guselkumab Intravenously (IV)
    Participants will receive a guselkumab dose IV based on their body weight (BW) during the 12-week open-label induction phase.
  • Experimental: Open-label Induction Phase: Guselkumab Subcutaneously (SC)
    Participants will receive a guselkumab dose SC based on their BW during the 12-week open-label induction phase.
  • Experimental: Double-blind Maintenance Phase: Guselkumab 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 BW up to Week 56.
  • Experimental: Double-blind Maintenance Phase: Guselkumab 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 BW up to Week 56.
  • 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 56.

Primary Outcome Measure

Percentage of Participants with Clinical Remission at Week 56 [ Time Frame: Week 56 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Children's Hospital OaklandOaklandCalifornia94609-
Riley Hospital for ChildrenIndianapolisIndiana46202-
NYU Langone HealthLake SuccessNew York11042-

Find similar trials in Oakland, CA

By research site
Children's Hospital Oakland· Oakland, CARiley Hospital for Children· Indianapolis, INNYU Langone Health· Lake Success, NY

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