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-NO
• 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: 2019-04-29
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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