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: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2018-002264-57-GB
- 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
- All
- Target Recruitment
- 650
• Male or female subjects between 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 Main Objective: To evaluate the efficacy and safety of upadacitinib versus dupilumab for the treatment of adult subjects with moderate to severe atopic dermatitis who are candidates for systemic therapy. ;Secondary Objective: 1. Percent change from Baseline to Week 16 in worst pruritus numerical rating scale (NRS)<br>2. Proportion of subjects achieving a 100% reduction in EASI (EASI 100) at Week 16<br>3. Proportion of subjects achieving a 90% reduction in EASI (EASI 90) at Week 16;Primary end point(s): Proportion of subjects achieving a 75% reduction in Eczema Area Severity Index (EASI 75) at Week 16;Timepoint(s) of evaluation of this end point: Week 16
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Week 1, 2, 4 and 16;Secondary end point(s): - Percent change from baseline to Week 16 in worst pruritus NRS<br>- Proportion of subjects achieving EASI 100 from baseline at Week 16<br>- Proportion of subjects achieving EASI 90 from baseline at Week 16<br>- Percent change from baseline to Week 4 in Worst Pruritus NRS<br>- Proportion of subjects achieving EASI 75 from baseline at Week 2<br>- Percent change from baseline to Week 1 in Worst Pruritus NRS