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A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)

NCT04630028 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2026-05-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics \[PK\]) in pediatric participants with moderately to severely active UC.

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

Ustekinumab Dose Based on BSA and Body Weight

As per BSA and body weight Ustekinumab will be administered SC and IV.

DRUG

Matching Placebo

Placebo will be administered subcutaneously.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-17
Primary Completion
2025-05-08
Completion
2025-06-05
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Germany
  • Hungary
  • Israel
  • Japan
  • Poland
  • Russia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04630028 on ClinicalTrials.gov