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

• Status: Recruiting
• Trial end date: 2025-07-29
• Target enrollment: 0
• Participant gender: All

Summary

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 (Cohorts 1 to 4 only).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Upadacitinib

Criteria

Inclusion Criteria:

• Participants with total body weight of 6 kilograms(kg) or higher at Baseline.

• For Participants 2 to <12 years of age: 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:

• 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.