Moderate to severe atopic dermatitis MedDRA version: 18.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Interventions
Product Name: OC000459
Product Code: OC000459
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: OC000459
Current Sponsor code: OC000459
Other descriptive name: OC000459
Concentration unit:
Sponsors
Atopix Therapeutics Ltd.
Eligibility
Sex/Gender
All
Inclusion 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. Well documented history of AD over the past 2 years in the patient notes, including the use of topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) and any investigator severity scores (EASI/SCORAD). Subjects without a well documented history will be excluded from the study. 3. Male and female subjects with moderate to severe atopic dermatitis treated with TCS and/or TCI ONLY (with or without emollients) at the time of screening and over the previous month. 4. Subjects must have had at least one flare in the previous 6 months. 5. Any racial group. 6. Females of childbearing potential (i.e. having had a menstrual period within two years prior to the date of screening) must practise two forms of contraception (i.e. two of the following – oral contraception, barrier contraception, spermicide, intrauterine device) and must have a negative pregnancy test (blood or urine) at screening. Men whose partners could be of child bearing potential should routinely use a condom during the study and for three months thereafter. The partner, if not pregnant, should also use a reliable form of contraception such as the oral contraceptive pill or intrauterine device. 7. Aged 18 to 48 years inclusive, stratified into subjects aged 18 to 30 inclusive and aged 31 to 48 inclusive. The aim will be to recruit 50% of subjects into each group. 8. Documented history of atopy– subjects without a fully documented history will be excluded from the study. 9. Eosinophils > 0.25 x 109/L blood at visit 1 (screening). 10. Total Serum IgE = 1000kU/L at the screening visit. 11. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. 12. Available to complete the study. 13. Subjects with health insurance coverage (France only). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Clinically significant abnormality in clinical laboratory tests at screening (visit 1) as determined by the Principal Investigator or designee. 2. Subjects with chronic conditions requiring daily medication will be excluded from the study except those subjects with asthma and/or allergic rhinitis, depression, hypertension, migraine, epilepsy and thyroid conditions. 3. Subjects testing positive for hepatitis C antibody, hepatitis B surface antigen or HIV. 4. 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 2 g daily, antidepressants, anti-hypertensives, anti-migraine, anti-epileptics, oral contraceptives, hormone replacement therapies and thyroid medications (see section 5.4.1). 5. Use of systemic steroids 4 weeks prior to the screening visit, light therapy or immunosuppressants 4 weeks prior to the screening visit. 6. Chronic use of NSAIDs (see section 5.4.1) 7. Subjects with contact dermatitis will be excluded. 8. 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. 9. Subjects with a known allergy to hydrocortisone butyrate 0.1% cream (Locoid® cream, Alfason® creme) will be excluded. 10. Participation in a study of an unlicensed drug or blood donation in the 3 months prior to the study. 11. The subject regularly, or on average, drinks more than four units of alcohol per day and/or uses drugs of abuse. 12. Females of child bearing potential who are unwilling to use two forms of contraception during the study and for a week after the last exposure to study medication. 13. Females who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of OC000459 50 mg given once a day orally in comparison to placebo on the severity and extent of atopic dermatitis using the Eczema Area and Severity Index (EASI) after a 16 week treatment period by subjects with active moderate to severe atopic dermatitis (AD) requiring treatment. ;Secondary Objective: •To assess the effects of OC000459 in comparison with placebo on various aspects of atopic dermatitis flare – number of flares, time to first flare, time to resolution of flares, proportion of flare free days (days where topical corticosteroids are not used) • To assess the effects of OC000459 in comparison to placebo on EASI score after 4, 8 and 12 weeks of treatment • To assess the effects of OC000459 in comparison to placebo on: Investigator Global Assessment (IGA) score Investigator assessment of subject’s severity of AD using the SCORing Atopic Dermatitis score (SCORAD) Subject’s assessment of itch Quality of life as measured using the Dermatology Life Quality Index (DLQI) & health status as assessed by EQ-5D-3L Severity and extent of atopic dermatitis using the Eczema Area and Severity Index (EASI) Subject’s assessment of their atopic dermatitis using the Patient Oriented SCORing atopic dermatitis (PO-SCORAD) score For more secondary objectives please see the protocol.;Primary end point(s): Change in EASI score after 16 weeks of treatment with OC000459 compared to placebo.;Timepoint(s) of evaluation of this end point: Weeks 0, 2, 4, 8, 12, 16, 18, 20. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Weeks 0, 2, 4, 8, 12, 16, 18, 20;Secondary end point(s): • Number of flares, time to first flare, time to resolution of flares (when subject stops medicating) and proportion of flare free days (days where topical corticosteroids are not used) during 16 weeks of treatment with OC000459 compared to placebo according to the subjects’ daily diary completion. For other secondary end points please see the protocol. | — |
Countries
Austria, Czech Republic, Finland, Germany, Poland, Slovakia, United Kingdom
Contacts
Public ContactClinical Trial Information
Atopix Therapeutics Ltd
Outcome results
None listed