Effect of OC000459 on Moderate to Severe Atopic Dermatitis

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

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).

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: OC000459

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 Type: Interventional
• Enrollment (Actual): 142
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Sheffield, United Kingdom
    • University of Sheffield

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OC000459 Tablets; 50 mg orally once a day	Drug: OC000459; Oral CRTH2 antagonist; Other Names: timapiprant
Placebo Comparator: Placebo Tablets; Orally once a day	Drug: OC000459; Oral CRTH2 antagonist; Other Names: timapiprant

What is the study measuring?

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	Time Frame
Rate of Flares	over 16 weeks

Collaborators and Investigators

• Sponsor: Atopix Therapeutics, Ltd.
• Investigators: Principal Investigator: Michael Cork, MB, University of Sheffield

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: November 26, 2013
• First Submitted That Met QC Criteria: November 29, 2013
• First Posted (Estimate): December 5, 2013

Study Record Updates

• Last Update Posted (Actual): March 26, 2018
• Last Update Submitted That Met QC Criteria: February 26, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: OC000459/017/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No