Effect of OC000459 on Moderate to Severe Atopic Dermatitis

The study will include patients with a Th2 high eosinophilic phenotype who typically have more severe disease and are prone to flare.

Inclusion criteria

• Atopic dermatitis as defined by a score of at least 9 on the Nottingham Eczema Severity Score, stratified into moderate (score 9 to 11 inclusive) and severe (score 12 to 15 inclusive) disease.
• Fully documented history of the use of topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI). Subjects without a fully documented history will be excluded from the study.
• Male and female subjects with moderate to severe atopic dermatitis treated with by TCS and/or TCI (with or without emollients) at the time of screening and over the previous month.
• Subjects must have had at least 1 AD flare in the previous 6 months.

Exclusion criteria

• Receipt of any forbidden medication including over the counter preparations and herbal medicines within 14 days of the first dosing day with the exception of paracetamol up to a maximum of 2g daily.
• Use of systemic steroids within 4 weeks of the screening visit, light therapy or immunosuppressants within 2 months of the screening visit.
• Use of NSAIDs.
• Subjects initially diagnosed with AD aged 2 years or over will be excluded unless they have either coexisting or a history of asthma and/or allergic rhinoconjunctivitis.
• Subjects with contact dermatitis will be excluded.
• Subjects with acute skin infection or acute disease flares. Subjects with active flares during the screening to randomisation period (visits 1 to 2) may be managed according to normal clinical practice and be rescreened once their flares are no longer active.

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