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A Long-term Extension Study of Ustekinumab in Pediatric Participants

NCT05092269 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2026-05-08

No results posted yet for this study

Summary

The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab

Conditions

  • Crohn Disease
  • Colitis, Ulcerative
  • Arthritis, Psoriatic

Interventions

DRUG

Ustekinumab

Ustekinumab will be administered as a 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
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-10-18
Primary Completion
2027-09-29
Completion
2028-03-15
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Japan
  • Poland
  • Spain
  • Turkey (Türkiye)
  • 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 NCT05092269 on ClinicalTrials.gov