NCT03646604CompletedPhase 1
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Participants With Severe Atopic Dermatitis
An Open-label Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Subjects With Severe Atopic Dermatitis
Source: ClinicalTrials.gov · Last updated 10 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The objective of this study is to evaluate the safety, pharmacokinetics and tolerability of multiple doses of upadacitinib in pediatric participants with severe atopic dermatitis and to evaluate palatability of upadacitinib oral solution in pediatric participants.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 23 Aug 2018
- Start date
- 31 Jan 2019
- Primary completion date
- 29 Aug 2024
- Lead sponsor
- AbbVie
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT03646604
- EudraCT number
- 2018-004409-17
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 35
- From 31 Jan 2019 to the primary completion date, 29 Aug 2024
- 18 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior exposure to Janus Kinase (JAK) inhibitor.
- Requirement of prohibited medications during the study.
- Current use of known moderate or strong inhibitors or inducers of drug metabolizing enzymes within 30 days prior to the first dose of study drug and through the end of Part 1 of the study.
Who the study is looking for
- Participants with total body weight of 10 kilograms(kg) or higher at Baseline. Beginning with protocol version 6.0, only subjects 3 years of age and older will be enrolled for the remainder of this study.
- Diagnosed with atopic dermatitis (AD) with onset of symptoms at least 6 months prior to baseline.
- Meets Hanifin and Rajka criteria for AD.
- Diagnosed with active severe AD defined by Eczema Area Severity Index (EASI), Validated Investigator's Global Assessment (IGA) and body surface area (BSA).
- Documented history (within 12 months prior to the Baseline Visit) of inadequate response or intolerance to topical corticosteroids (TCS) and topical calcineurin inhibitor (TCI) OR for whom use of TCS and TCIs is otherwise medically inadvisable.
Age in the registry: 2 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Haukeland University Hospital /ID# 210162 Coordinator of this site? Confirm its status | Bergen | Norway | Unknown status |
| Rikshospitalet OUS HF /ID# 210163 Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Alma M. Cruz Santana, MD-Private practice /ID# 214890 Coordinator of this site? Confirm its status | Carolina | Puerto Rico | Unknown status |
| University of New Mexico School of Medicine /ID# 206757 Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Arlington Research Center, Inc /ID# 222901 Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
| Northwestern University Feinberg School of Medicine /ID# 206224 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cincinnati Children's Hospital /ID# 207071 Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| IACT Health-Columbus /ID# 216370 Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Pediatric Skin Research, LLC /ID# 213468 Coordinator of this site? Confirm its status | Coral Gables | United States | Unknown status |
| Rybear, Inc /ID# 231801 Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Penn State University and Milton S. Hershey Medical Center /ID# 207096 Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| Beach Pediatrics /ID# 207834 Coordinator of this site? Confirm its status | Huntington Beach | United States | Unknown status |
| Dawes Fretzin, LLC /ID# 214958 Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Children's Hospital Los Angeles /ID# 206042 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| West Virginia University Hospitals /ID# 206792 Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| Paddington Testing Co., Inc. /ID# 207079 Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Oregon Medical Research Center /ID# 206226 Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Duplicate_Washington University of St. Louis /ID# 206972 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.