atopic eczema eczema
Conditions
Interventions
Subjects will be randomized in a 1:1 ratio and will receive upadacitinib or
dupilumab and placebo until Week 24 visit:
• Upadacitinib tablets + placebo pre-filled syringe
OR
• Dupilumab + placebo tablet
Sponsors
Abbvie b.v.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving a 75% reduction in Eczema Area Severity Index (EASI 75) at Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percent change from baseline to Week 16 in Worst Pruritus NRS 2. Proportion of subjects achieving EASI 100 from baseline at Week 16 3. Proportion of subjects achieving EASI 90 from baseline at Week 16 4. Percent change from baseline to Week 4 in Worst Pruritus NRS 5. Proportion of subjects achieving EASI 75 from baseline at Week 2 6. Percent change from baseline to Week 1 in Worst Pruritus NRS | — |
Countries
Netherlands
Outcome results
None listed