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Effect of OC000459 on Moderate to Severe Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02002208
Recruitment Status : Completed
First Posted : December 5, 2013
Results First Posted : December 8, 2016
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: OC000459 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : October 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: OC000459 Tablets
50 mg orally once a day
Drug: OC000459
Oral CRTH2 antagonist
Other Name: timapiprant

Placebo Comparator: Placebo Tablets
Orally once a day
Drug: OC000459
Oral CRTH2 antagonist
Other Name: timapiprant




Primary Outcome Measures :
  1. Change From Baseline in Eczema Area and Severity Index (EASI) Compared to Placebo at Week 16 [ Time Frame: 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 :
  1. Rate of Flares [ Time Frame: over 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002208


Locations
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United Kingdom
University of Sheffield
Sheffield, United Kingdom
Sponsors and Collaborators
Atopix Therapeutics, Ltd.
Investigators
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Principal Investigator: Michael Cork, MB University of Sheffield
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Responsible Party: Atopix Therapeutics, Ltd.
ClinicalTrials.gov Identifier: NCT02002208    
Other Study ID Numbers: OC000459/017/13
First Posted: December 5, 2013    Key Record Dates
Results First Posted: December 8, 2016
Last Update Posted: March 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases