Effect of OC000459 on Moderate to Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02002208
• Other study ID #: OC000459/017/13
• Status: Completed
• Phase: Phase 2
• First received: November 26, 2013
• Last updated: February 26, 2018
• Start date: October 2013
• Est. completion date: February 2016

Study information

• Verified date: February 2018
• Source: Atopix Therapeutics, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: February 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 48 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• OC000459
Oral CRTH2 antagonist

Locations

Country	Name	City	State
United Kingdom	University of Sheffield	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Atopix Therapeutics, Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of Flares		over 16 weeks