This is a study to evaluate dose-flexibility of Upadacitinib in Adult Subjectswith Moderate to Severe Atopic Dermatitis
- Conditions
- Moderate to Severe Atopic DermatitisMedDRA version: 20.0Level: PTClassification code 10012438Term: Dermatitis atopicSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2022-000434-42-SK
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 454
•Male or female subjects =18 and < 65 years of age at the Screening Visit
•Chronic AD with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria
•Candidate for systemic treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 454
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Prior exposure to any JAK inhibitor
• Unable or unwilling to discontinue current AD treatments prior to the study
• Requirement of prohibited medications during the study treatment
• Female subject who is pregnant, breastfeeding, or considering pregnancy during the
study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. Sub-Study 1 (SS1): The primary study objective for SS1 is to evaluate the efficacy and safety of dose escalation to upadacitinib 30 mg QD in subjects who do not achieve Eczema Area and Severity Index (EASI) 90 on upadacitinib 15 mg QD after 12 weeks.<br>2. Sub-Study 2 (SS2): The primary study objective for SS2 is to evaluate the efficacy and safety of dose reduction to upadacitinib 15 mg QD in subjects who achieve EASI 90 on upadacitinib 30 mg QD after 12 weeks.<br>No hypothesis testing will be performed in this study.<br>;Secondary Objective: N/A;Primary end point(s): The primary endpoints is:<br>Achievement of EASI 90 at Week 24.<br>;Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method