Effect of OC000459 on Moderate to Severe Atopic Dermatitis

NCT02002208 | Completed Phase 2 Results

• 1 other identifier: OC000459/017/13
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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).

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of Flares

  over 16 weeks

Study Arms (2)

OC000459 Tablets

EXPERIMENTAL

50 mg orally once a day

Drug: OC000459

Placebo Tablets

PLACEBO COMPARATOR

Orally once a day

Drug: OC000459

Interventions

OC000459 DRUG

Oral CRTH2 antagonist

Also known as: timapiprant

OC000459 Tablets; Placebo Tablets

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atopix Therapeutics, Ltd.: lead

Study Sites (1)

University of Sheffield

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

(5-fluoro-2-methyl-3-quinolin-2-ylmethylindo-1-yl)acetic acid

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Atopix Therapeutics Limited

atopix@atopixtherapeutics.co.uk

+44 1235 841 522

Study Officials

• Michael Cork, MB

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 5, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: February 1, 2016
• Last Updated: March 26, 2018
• Results First Posted: December 8, 2016

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)