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NCT05092269 · ClinicalTrials.gov registry record · Phase 3
A Long-term Extension Study of Ustekinumab in Pediatric Participants
A Phase 3 study of Crohn Disease and Colitis, Ulcerative, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 159
- Enrollment target
- 20
- Study locations
NCT05092269: Active Phase 3 study of Crohn Disease and Colitis, Ulcerative, sponsored by Janssen Research & Development.
NCT05092269 is a Phase 3 study of Crohn Disease and Colitis, Ulcerative that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 159 participants, below the 203-participant average among 71 other Crohn Disease trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05092269, a Phase 3 study of Crohn Disease and Colitis, Ulcerative, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 159 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab
Primary Outcome
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.
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 |
What the registry record for NCT05092269 still lists
NCT05092269 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, below the 203-participant average among 71 other Crohn Disease trials with a reported enrollment target (22% lower).
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.
NCT05092269 names 20 study sites across 5 states, led by Other, Georgia, New York.
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.
What interventions are being tested in trial NCT05092269?
The interventions under investigation include: Ustekinumab (DRUG).
Who is sponsoring clinical trial NCT05092269?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Crohn Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05092269's enrollment target sits among peer trials
159 25th of 71 higher than 47 of 71 other Crohn Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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