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A Long-term Extension Study of Ustekinumab in Pediatric Participants
NCT05092269 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab
Conditions Studied
Interventions
- DRUG Ustekinumab
Study Locations (20)
Other
- 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
Georgia
- Children's Center For Digestive Healthcare, Llc — Atlanta
New York
- Mount Sinai — New York
North Carolina
- Levine Childrens at Atrium Health — Charlotte
Virginia
- Pediatric Specialists Of Virginia — Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2021-10-18 |
| Est. Completion | 2028-03-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05092269
The ClinicalTrials.gov registry entry for NCT05092269 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 159 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Crohn Disease appearing as the primary indexed condition, and to 1 intervention — of which Ustekinumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05092269 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Other, Georgia, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05092269 about?
NCT05092269 is a clinical study titled "A Long-term Extension Study of Ustekinumab in Pediatric Participants". The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab
What is the current status of trial NCT05092269?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 159 participants. The study started on 2021-10-18. Estimated completion is 2028-03-15.
What conditions does trial NCT05092269 study?
This clinical trial studies the following conditions: Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05092269?
The interventions under investigation include: Ustekinumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05092269?
This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05092269 being conducted?
This trial has 20 study locations across Georgia, New York, North Carolina, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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