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Effect of OC000459 on Moderate to Severe Atopic Dermatitis

NCT ID: NCT02002208

Last Updated: 2018-03-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-02-29

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.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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OC000459 Tablets

50 mg orally once a day

Group Type EXPERIMENTAL

OC000459

Intervention Type DRUG

Oral CRTH2 antagonist

Placebo Tablets

Orally once a day

Group Type PLACEBO_COMPARATOR

OC000459

Intervention Type DRUG

Oral CRTH2 antagonist

Interventions

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OC000459

Oral CRTH2 antagonist

Intervention Type DRUG

Other Intervention Names

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timapiprant

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. 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.
3. 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.
4. Subjects must have had at least 1 AD flare in the previous 6 months.

Exclusion Criteria

1. 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.
2. Use of systemic steroids within 4 weeks of the screening visit, light therapy or immunosuppressants within 2 months of the screening visit.
3. Use of NSAIDs.
4. 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.
5. Subjects with contact dermatitis will be excluded.
6. 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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Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atopix Therapeutics, Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Cork, MB

Role: PRINCIPAL_INVESTIGATOR

University of Sheffield

Locations

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University of Sheffield

Sheffield, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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OC000459/017/13

Identifier Type: -

Identifier Source: org_study_id