A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects with Moderate to Severe Atopic Dermatitis.
Phase 3
Completed
- Conditions
- atopic eczemaeczema10014982
- Registration Number
- NL-OMON49672
- Lead Sponsor
- Abbvie b.v.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
• Male or female subjects 18 between 75 years of age
• 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
Exclusion Criteria
• 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
• 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Proportion of subjects achieving a 75% reduction in Eczema Area Severity Index<br /><br>(EASI 75) at Week 16</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Percent change from baseline to Week 16 in Worst Pruritus NRS<br /><br>2. Proportion of subjects achieving EASI 100 from baseline at Week 16<br /><br>3. Proportion of subjects achieving EASI 90 from baseline at Week 16<br /><br>4. Percent change from baseline to Week 4 in Worst Pruritus NRS<br /><br>5. Proportion of subjects achieving EASI 75 from baseline at Week 2<br /><br>6. Percent change from baseline to Week 1 in Worst Pruritus NRS</p><br>