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