The study will assess the safety and efficacy of QGE031 in the treatment of moderate to severe atopic dermatitis patients. In addition, QGE031 levels in the blood will be measured and the effect of QGE031 on markers in the blood and skin will be evaluated. Comparisons of the effect of QGE31 will be made with placebo and also cyclosporine, a treatment already established as being effective in atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
22
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Nice, France
Novartis Investigative Site
Kiel, Germany, Germany
Novartis Investigative Site
Bonn, Germany
Change in Eczema Area and Severity Index(EASI)
Efficacy response will be assessed using EASI.
Time frame: baseline, 12 weeks
Change in Investigator Global Assessment (IGA) for atopic dermatitis
Participants dermatitis will be visually assessed and an IGA score will be determined by the Investigator using a prespecified evaluation criteria.
Time frame: 6 weeks, 12 weeks
Number of participants with adverse events
Adverse events will be determined by observation and non-leading questioning of patients, and by measuring safety parameters (electrocardiograms, clinical laboratory, blood pressure)
Time frame: 24 weeks
QGE031 plasma concentrations
Blood samples will be collected on Day 1(predose),15, 29, 43, 57, 71, 85, 99, 113, 127, 141, 155, and 169 for determination of QGE031 serum levels
Time frame: 24 weeks
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