🏛️ Verified NIH Record • Updated 2026-08-27

A Long-term Extension Study of Ustekinumab in Pediatric Participants (NCT05092269)

A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Janssen Research & Development, LLC

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: Review the eligibility criteria below.

Location: Children's Center For Digestive Healthcare, Llc — Atlanta, Georgia

Age range: 2 Years to 17 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (48 Sites)

Showing the first 25 of 48 sites.

  • Children's Center For Digestive Healthcare, Llc — Atlanta, Georgia
  • Mount Sinai — New York, New York
  • Levine Childrens at Atrium Health — Charlotte, North Carolina
  • Pediatric Specialists Of Virginia — Fairfax, Virginia
  • STAT Research S A — Buenos Aires,
  • Hospital de Ninos de Cordoba — Córdoba,
  • Centro de Investigaciones Medicas Tucuman — San Miguel de Tucumán,
  • Huderf — Brussels,
  • Cliniques Universitaires Saint Luc — Brussels,
  • UZ Gent — Ghent,
  • UZ Brussel — Jette,
  • Uz Gasthuisberg — Leuven,
  • Hôpital Necker — Paris,
  • Universitaetsklinikum der RWTH Aachen — Aachen,
  • Charite Universitatsmedizin Berlin Campus Virchow Klinikum — Berlin,
  • Semmelweis Egyetem — Budapest,
  • Debreceni Egyetem Klinikai Kozpont — Debrecen,
  • Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz — Miskolc,
  • Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz — Nyíregyháza,
  • Szegedi Tudomanyegyetem — Szeged,
  • Yitzhak Shamir Medical Center — Beer Yaakov,
  • Shaare Zedek Medical Center — Jerusalem,
  • Sheba Medical Center — Ramat Gan,
  • Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano — Milan,
  • Juntendo University Hospital — Bunkyō City,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗