The purpose of this study is to determine whether OC000459 is in reducing disease severity and preventing flares in people with moderate to severe atopic dermatitis (AD).
The study will include patients with a Th2 high eosinophilic phenotype who typically have more severe disease and are prone to flare.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
142
Oral CRTH2 antagonist
University of Sheffield
Sheffield, United Kingdom
Change From Baseline in Eczema Area and Severity Index (EASI) Compared to Placebo at Week 16
The EASI scoring system uses a defined process to grade the severity of the signs of eczema and the extent affected in four regions of the body: head and neck, trunk, upper extremities and lower extremities. The scale ranges from 0 to 72 and the severity strata for the EASI are as follows: 0 clear; 0.1-1.0 almost clear; 1.1-7.0 mild; 7.1-21.0 =moderate; 21.1-50.0 severe; 50.1-72.0 very severe. When assessing response to therapy a reduction of 7 or more is considered to be clinically meaningful.
Time frame: EASI was measured at baseline (week 0) and 16 weeks after dosing.
Rate of Flares
Time frame: over 16 weeks
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