A study to evaluate the pharmacokinetics, safety and tolerability of upadacitinib in pediatric subjects with severe atopic dermatitis

Phase 1

• Conditions: Severe Atopic Dermatitis; MedDRA version: 20.0Level: PTClassification code 10012438Term: Dermatitis atopicSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-004409-17-NL
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-13
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Participants with total body weight of 10 kg or higher at Baseline
• Participants diagnosed with active severe atopic dermatitis (AD) defined by the Eczema Area Severity Index (EASI), Investigator’s Global Assessment (IGA) and body surface area (BSA)
• Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis

Are the trial subjects under 18? yes
Number of subjects for this age range: 32
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Prior exposure to Janus Kinase (JAK) inhibitor
• Requirement of prohibited medications during the study
• Systemic use of known moderate or strong inhibitors or inducers of drug metabolizing enzymes within 1 month of the first dose of study drug and through the end of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Part 1: To evaluate the pharmacokinetics, activity, safety and tolerability of multiple doses of upadacitinib in pediatric subjects with severe atopic dermatitis. To evaluate the palatability of upadacitinib oral solution in pediatric subjects. <br><br>Part 2: To evaluate the long term safety and tolerability of multiple doses of upadacitinib in pediatric subjects with severe atopic dermatitis.<br>;Secondary Objective: NA;Primary end point(s): The values for the pharmacokinetic parameters of upadacitinib including Cmax, the time to Cmax (Tmax), area under the plasma concentration versus time curve during a dosing interval (AUCtau) on Day 7, and apparent oral clearance at steady state (CL/F) will be determined using non-compartmental methods.;Timepoint(s) of evaluation of this end point: Day 7

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety evaluations include incidence of Treatment Emergent Adverse Events (TEAEs), physical examination results, change in vital sign measurements, electrocardiogram (ECG) variables, and clinical laboratory testing (hematology, chemistry, and urinalysis) as measures of safety and tolerability for the entire study duration.;Timepoint(s) of evaluation of this end point: Week 108