A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Participants With Severe Atopic Dermatitis
NCT ID: NCT03646604
Last Updated: 2025-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
35 participants
INTERVENTIONAL
2019-01-31
2024-08-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1; Cohort 1
Participants, 6 to \<12 years of age, will receive low dose of upadacitinib.
Upadacitinib (ABT-494)
Upadacitinib will be administered orally.
Part 1; Cohort 2
Participants, 6 to \<12 years of age, will receive high dose of upadacitinib.
Upadacitinib (ABT-494)
Upadacitinib will be administered orally.
Part 1; Cohort 3
Participants, 2 to \<6 years of age, will receive low dose of upadacitinib.
Upadacitinib (ABT-494)
Upadacitinib will be administered orally.
Part 1; Cohort 4
Participants, 2 to \<6 years of age, will receive high dose of upadacitinib.
Upadacitinib (ABT-494)
Upadacitinib will be administered orally.
Part 2
Eligible participants who completed Part 1 will receive weight-dependant low dose of upadacitinib.
Upadacitinib (ABT-494)
Upadacitinib will be administered orally.
Interventions
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Upadacitinib (ABT-494)
Upadacitinib will be administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
2 Years
12 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Beach Pediatrics /ID# 207834
Huntington Beach, California, United States
Children's Hospital Los Angeles /ID# 206042
Los Angeles, California, United States
Pediatric Skin Research, LLC /ID# 213468
Coral Gables, Florida, United States
Rybear, Inc /ID# 231801
Fort Lauderdale, Florida, United States
IACT Health-Columbus /ID# 216370
Columbus, Georgia, United States
Northwestern University Feinberg School of Medicine /ID# 206224
Chicago, Illinois, United States
Dawes Fretzin, LLC /ID# 214958
Indianapolis, Indiana, United States
Duplicate_Washington University of St. Louis /ID# 206972
St Louis, Missouri, United States
University of New Mexico School of Medicine /ID# 206757
Albuquerque, New Mexico, United States
Cincinnati Children's Hospital /ID# 207071
Cincinnati, Ohio, United States
Oregon Medical Research Center /ID# 206226
Portland, Oregon, United States
Penn State University and Milton S. Hershey Medical Center /ID# 207096
Hershey, Pennsylvania, United States
Paddington Testing Co., Inc. /ID# 207079
Philadelphia, Pennsylvania, United States
Arlington Research Center, Inc /ID# 222901
Arlington, Texas, United States
West Virginia University Hospitals /ID# 206792
Morgantown, West Virginia, United States
Haukeland University Hospital /ID# 210162
Bergen, Hordaland, Norway
Rikshospitalet OUS HF /ID# 210163
Oslo, , Norway
Alma M. Cruz Santana, MD-Private practice /ID# 214890
Carolina, , Puerto Rico
Countries
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References
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Qian Y, Raymundo EM, Hao S, Unnebrink K, Levy GF, Teixeira HD, Chu AD, Zinn ZA, Paller AS, Liu W, Mohamed MF. Pharmacokinetics, Safety, Tolerability, and Exploratory Efficacy of Upadacitinib in Children with Severe Atopic Dermatitis. Clin Ther. 2024 Oct;46(10):733-741. doi: 10.1016/j.clinthera.2024.07.003. Epub 2024 Aug 13.
Related Links
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clinical study report synopsis
Other Identifiers
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2018-004409-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M16-049
Identifier Type: -
Identifier Source: org_study_id
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