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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
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

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Haukeland University Hospital /ID# 210162
Coordinator of this site? Confirm its status
BergenNorwayUnknown status
Rikshospitalet OUS HF /ID# 210163
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OsloNorwayUnknown status
Alma M. Cruz Santana, MD-Private practice /ID# 214890
Coordinator of this site? Confirm its status
CarolinaPuerto RicoUnknown status
University of New Mexico School of Medicine /ID# 206757
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AlbuquerqueUnited StatesUnknown status
Arlington Research Center, Inc /ID# 222901
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ArlingtonUnited StatesUnknown status
Northwestern University Feinberg School of Medicine /ID# 206224
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ChicagoUnited StatesUnknown status
Cincinnati Children's Hospital /ID# 207071
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CincinnatiUnited StatesUnknown status
IACT Health-Columbus /ID# 216370
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ColumbusUnited StatesUnknown status
Pediatric Skin Research, LLC /ID# 213468
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Coral GablesUnited StatesUnknown status
Rybear, Inc /ID# 231801
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Fort LauderdaleUnited StatesUnknown status
Penn State University and Milton S. Hershey Medical Center /ID# 207096
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HersheyUnited StatesUnknown status
Beach Pediatrics /ID# 207834
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Huntington BeachUnited StatesUnknown status
Dawes Fretzin, LLC /ID# 214958
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IndianapolisUnited StatesUnknown status
Children's Hospital Los Angeles /ID# 206042
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Los AngelesUnited StatesUnknown status
West Virginia University Hospitals /ID# 206792
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MorgantownUnited StatesUnknown status
Paddington Testing Co., Inc. /ID# 207079
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PhiladelphiaUnited StatesUnknown status
Oregon Medical Research Center /ID# 206226
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PortlandUnited StatesUnknown status
Duplicate_Washington University of St. Louis /ID# 206972
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St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.