A Study to Compare Study Drug ABT-494 to Placebo in Adult Subjects with Moderate to Severe Atopic Dermatitis (Atopic Eczema).
- Conditions
- Atopic Dermatitis in adultsMedDRA version: 19.0 Level: PT Classification code 10012438 Term: Dermatitis atopic System Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2016-002451-21-BE
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 160
• 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 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 128
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32
• 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Not applicable;Primary end point(s): Mean percent (%) change from Baseline (Day 1) in EASI score at Week 16.;Timepoint(s) of evaluation of this end point: week 16;Main Objective: To evaluate the safety and efficacy of multiple doses of ABT-494 monotherapy versus placebo in the treatment of adults with moderate to severe atopic dermatitis
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): • 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)<br> • Proportion of subjects achieving an Investigator Global Assessment (IGA) of 0 or 1 at Week 16<br> • Percent change from Baseline to Weeks 2, 8 and 16 in pruritus numerical rating scale (NRS)<br> • Percent change in EASI score from Baseline at Week 8<br> • Proportion of subjects achieving EASI 50/75/90 response at Weeks 8 and 16<br> • Proportion of subjects achieving SCORAD 50/75/90 response at Weeks 8 and 16<br> • Proportion of subjects with Dermatology Life Quality Index (DLQI) = 0 or 1 at Weeks 8 and 16<br> • Change from Baseline in DLQI at Weeks 8 and 16<br> ;Timepoint(s) of evaluation of this end point: Week 8 and Week 16