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    Summary
    EudraCT Number:2013-001924-20
    Sponsor's Protocol Code Number:OC000459/017/13
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-28
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2013-001924-20
    A.3Full title of the trial
    A study of the effect of OC000459 on signs & symptoms in subjects with moderate to severe atopic dermatitis: A randomised double blind placebo controlled parallel group study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to see the effect of OC000459 in people with eczema
    A.4.1Sponsor's protocol code numberOC000459/017/13
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAtopix Therapeutics Ltd.
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAtopix Therapeutics Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAtopix Therapeutics Ltd
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressInnovation Centre, 99 Park Drive, Milton Park
    B.5.3.2Town/ cityAbingdon
    B.5.3.3Post codeOX14 4RY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441235841522
    B.5.5Fax number441235841562
    B.5.6E-mailatopix@atopixtherapeutics.co.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOC000459
    D.3.2Product code OC000459
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOC000459
    D.3.9.2Current sponsor codeOC000459
    D.3.9.3Other descriptive nameOC000459
    D.3.9.4EV Substance CodeSUB26981
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe atopic dermatitis
    E.1.1.1Medical condition in easily understood language
    Moderate to severe atopic dermatitis
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    •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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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 an intrauterine device.
    7. Aged 18 to 48 years inclusive, stratified into subjects aged 18 to 30 inclusive and over 30 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 on 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).
    E.4Principal 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
    3. Subjects testing positive for hepatitis C antibody, hepatitis B surface antigen or HIV.
    4. Receipt of any forbidden medication (see section 5.4.1) 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.
    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.
    7. 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 rhino conjunctivitis.
    8. Subjects with contact dermatitis will be excluded.
    9. 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.
    10. Total Serum IgE<1000kU/L at the screening visit.
    11. Subjects with a known allergy to hydrocortisone, hydrocortisone butyrate 0.1% cream (Locoid® cream, Alfason® creme) or hydrocortisone acetate will be excluded.
    12. Participation in a study of an unlicensed drug or blood donation in the 3 months prior to the study.
    13. The subject regularly, or on average, drinks more than four units of alcohol per day and/or uses drugs of abuse.
    14. 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.
    15. Females who are pregnant or breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    Change in EASI score after 16 weeks of treatment with OC000459 compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 0, 2, 4, 8, 12, 16, 18 and 20
    E.5.2Secondary 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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 0, 2, 4, 8, 12, 16, 18 and 20
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Genotyping sample
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 140
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 140
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not applicable.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-24
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