Effect of OC000459 on Moderate to Severe Atopic Dermatitis

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: OC000459

• Registration Number: NCT02002208
• Lead Sponsor: Atopix Therapeutics, Ltd.

Brief 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).

Detailed Description

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

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-26
• Study First Submitted QC: 2013-11-29
• Study First Posted: 2013-12-05
• Primary Completion: 2015-09
• Study Completion: 2016-02
• Results First Submitted: 2016-07-12
• Results First Submitted QC: 2016-10-17
• Results First Posted: 2016-12-08
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-26
• Last Update Posted: 2018-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OC000459 Tablets	OC000459	50 mg orally once a day
Placebo Tablets	OC000459	Orally once a day

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Eczema Area and Severity Index (EASI) Compared to Placebo at Week 16	EASI was measured at baseline (week 0) and 16 weeks after dosing.	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.

Secondary Outcome Measures

Name	Time	Method
Rate of Flares	over 16 weeks

Trial Locations

Locations (1)

University of Sheffield; 🇬🇧 Sheffield, United Kingdom