Effect of OC000459 on Moderate to Severe Atopic Dermatitis

Study Overview
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Brief Summary
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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).

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

Official Title
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A Study of the Effect of OC000459 on Signs and Symptoms in Subjects With Moderate to Severe Atopic Dermatitis: A Randomised Double Blind Placebo Controlled Parallel Group Study

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: OC000459


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OC000459 Tablets<br>50 mg orally once a day | Drug: OC000459<br>* Oral CRTH2 antagonist<br>* Other names: timapiprant;|
| Placebo Comparator: Placebo Tablets<br>Orally once a day | Drug: OC000459<br>* Oral CRTH2 antagonist<br>* Other names: timapiprant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | EASI was measured at baseline (week 0) and 16 weeks after dosing. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Flares |  | over 16 weeks |