AD Up
Phase 3
Completed
- Conditions
- Atopic Dermatitis
- Registration Number
- jRCT2080224016
- Lead Sponsor
- AbbVie GK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 74
Inclusion Criteria
- Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus
- Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis
Exclusion Criteria
- Prior exposure to any Janus kinase (JAK) inhibitor
- Unable or unwilling to discontinue current atopic dermatitis (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
- This study includes a 35-day screening period, a 16-week double-blind period, a blinded extension period up to Week 260, a blinded Long-term Extension (LTE) Period after Week 260 to Week 524, and a 30-day follow-up visit. Participants who meet eligibility criteria will be randomly assigned in a 1:1:1 ratio to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo once daily, in combination with topical corticosteroids. At Week 16, participants in the placebo group will be re-randomized in a 1:1 ratio to receive daily oral doses of upadacitinib 30 mg or upadacitinib 15 mg in the blinded extension period, ans participants originally randomized to upadacitinib will continue upadacitinib in the extension period at the same dose. Participants from M16-045 or M18-891 and participants from M16-047 will have the opportunity to enroll into the blinded LTE period after reaching Week 260 in their respective studies.
- Primary Outcome Measures
Name Time Method EASI 75 Week 16 Proportion of subjects achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from Baseline
vIGA-AD Week 16 Proportion of subjects achieving validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction from Baseline
- Secondary Outcome Measures
Name Time Method Proportion of participants achieving an improvement (reduction) of 4 or more in worst pruritus Numerical Rating Scale (NRS) week 16 Proportion of participants achieving an improvement (reduction) of 4 or more in worst pruritus Numerical Rating Scale (NRS)
Proportion of participants achieving EASI 90 week 16 Proportion of participants achieving EASI 90
Proportion of subjects achieving EASI 75 Week 4 Proportion of subjects achieving EASI 75
Proportion of subjects achieving EASI 100 Week 16 Proportion of subjects achieving EASI 100 in certain arms
Proportion of subjects achieving vIGA-AD of 0 Week 16 Proportion of subjects achieving vIGA-AD of 0 in certain arms
Trial Locations
- Locations (1)
Asia except Japan/North America/South America/Europe/Japan/Oceania/Africa
Location not specified
Asia except Japan/North America/South America/Europe/Japan/Oceania/Africa