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

NCT04673357 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2025-11-28

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of ustekinumab dosing in inducing clinical remission (Global) and in maintaining clinical remission (US); to evaluate the safety profile and ustekinumab exposure (pharmacokinetics \[PK\]) in pediatric participants with moderately to severely active Crohn's disease.

Conditions

  • Crohn Disease

Interventions

DRUG

Ustekinumab

Ustekinumab will be administered intravenously in induction period and subcutaneously in maintenance period.

DRUG

Placebo

Matching placebo will be administered as SC injection.

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
2021-04-06
Primary Completion
2024-11-28
Completion
2025-03-03
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs

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 NCT04673357 on ClinicalTrials.gov