This is a Phase 3, randomized, multi-center study that will evaluate upadacitinib versus dupilumab in adults (18 – 75 years of age) with moderate to severe AD who are candidates for systemic therapy. The study is comprised of a 35-day Screening Period, a 24-week blinded treatment period, and a 12-week Follow-up period.
- Conditions
- moderate to severe Atopic DermatitisMedDRA version: 20.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2018-002264-57-SE
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 650
• Male or female subjects 18 years old and 75 years old
• Active moderate to severe atopic dermatitis defined by EASI, IGA, BSA, and pruritus
• Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis
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 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
• Prior exposure to any JAK inhibitor or Dupilumab
• Unable or unwilling to discontinue current AD treatments prior to the study
• Requirement of prohibited medications during the study
• Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
• 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
- Secondary Outcome Measures
Name Time Method