A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Participants With Severe Atopic Dermatitis

Completed · Phase 1

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT03646604

Run by

AbbVie

People needed

35

Starts

2019-01-31

Expected to finish

2024-08-29

Last updated by the study team

2025-02-10

Who can join

Age: 2 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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