A Phase 2b Multicenter, Randomized, Placebo-Controlled, Double-Blind Dose-Ranging Study to Evaluate ABT-494 (Upadacitinib) in Adult Subjects with Moderate to Severe Atopic Dermatitis

Phase 2

Completed

Conditions: atopic eczema
eczema
10014982

Registration Number: NL-OMON45624

Lead Sponsor: AbbVie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 17

Inclusion Criteria

• Adult male or female, >= 18 and <= 75 years old at Screening.;• Atopic dermatitis with a diagnosis confirmed by a dermatologist (according to the Hanifin and Rajka criteria) and also onset of symptoms at least 1 year prior to baseline.;• Moderate to severe atopic dermatitis defined by an EASI >= 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

• 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Mean percent (%) change from Baseline (Day 1) in EASI score at Week 16.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Proportion of subjects achieving an EASI 75 response, defined as at<br /><br>least a 75% reduction in EASI score, at Week 16 relative to the Baseline<br /><br>(Day 1)<br /><br>• Proportion of subjects achieving an Investigator Global Assessment<br /><br>(IGA) of 0 or 1 at Week 16<br /><br>• Percent change from Baseline to Weeks 2, 8 and 16 in pruritus<br /><br>numerical rating scale (NRS)<br /><br>• Percent change in EASI score from Baseline at Week 8<br /><br>• Proportion of subjects achieving EASI 50/75/90 response at Weeks 8<br /><br>and 16<br /><br>• Proportion of subjects achieving SCORAD 50/75/90 response at Weeks<br /><br>8 and 16<br /><br>• Proportion of subjects with Dermatology Life Quality Index (DLQI) =<br /><br>0 or 1 at Weeks 8 and 16<br /><br>• Change from Baseline in DLQI at Weeks 8 and 16</p><br>