atopic eczema eczema
Conditions
Interventions
Subjects will take once daily one tablet of ABT-494 (Upadacitinib) (low dose,
medium dose or high dose), or matching placebo for 88 weeks.
Sponsors
AbbVie
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Adult male or female, >= 18 and = 16, BSA >= 10% and an IGA score >= 3 at the Baseline visit.;• Documented history (within 1 year prior to the screening visit) of inadequate response to treatment with topical corticosteroids (TCS), or topical calcineurin inhibitors (TCI), or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).;• Twice daily use of an additive-free, bland emollient for at least 7 days prior to Baseline.
Exclusion criteria
Exclusion criteria: • Prior exposure to any systemic or topical JAK inhibitor (including but not limited to tofacitinib, baricitinib, ruxolitinib, and filgotinib).;• Treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin within 10 days prior to the Baseline visit.;• Prior exposure to dupilumab.;• Prior exposure to any investigational systemic treatment within 30 days or 5 half-lives (whichever is longer) of the Baseline visit or is currently enrolled in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percent (%) change from Baseline (Day 1) in EASI score at Week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Proportion of subjects achieving an EASI 75 response, defined as at least a 75% reduction in EASI score, at Week 16 relative to the Baseline (Day 1) • Proportion of subjects achieving an Investigator Global Assessment (IGA) of 0 or 1 at Week 16 • Percent change from Baseline to Weeks 2, 8 and 16 in pruritus numerical rating scale (NRS) • Percent change in EASI score from Baseline at Week 8 • Proportion of subjects achieving EASI 50/75/90 response at Weeks 8 and 16 • Proportion of subjects achieving SCORAD 50/75/90 response at Weeks 8 and 16 • Proportion of subjects with Dermatology Life Quality Index (DLQI) = "0" or "1" at Weeks 8 and 16 • Change from Baseline in DLQI at Weeks 8 and 16 | — |
Countries
Netherlands
Outcome results
None listed