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    Summary
    EudraCT Number:2016-003013-96
    Sponsor's Protocol Code Number:AVXCLIN003
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-27
    Trial 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 ConcernedDenmark - DHMA
    A.2EudraCT number2016-003013-96
    A.3Full title of the trial
    A Randomised, Blinded, Placebo-controlled, Single Centre Pilot Study to evaluate the Safety and Efficacy of AVX001 3% Ointment (NG) administered Topically Once Daily to Patients with mild, moderate or severe Atopic Dermatitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Avexxin (AVX001) 3% Ointment (NG) in Atopic Dermatitis – safety and efficacy study
    A.4.1Sponsor's protocol code numberAVXCLIN003
    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 SponsorAvexxin AS
    B.1.3.4CountryNorway
    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 supportAvexxin AS
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAVEXXIN AS
    B.5.2Functional name of contact pointPeter Damsbo
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Biology, NTNU, Høgskoleringen 5
    B.5.3.2Town/ cityTrondheim
    B.5.3.3Post code7491
    B.5.3.4CountryNorway
    B.5.4Telephone number+4528 43 34 78
    B.5.6E-mailpeter@damsbo.net
    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 nameAVX001 ointment
    D.3.2Product code AVX001
    D.3.4Pharmaceutical form Ointment
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAVX001
    D.3.9.3Other descriptive nameAVX001
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 placeboOintment
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    E.1.1.1Medical condition in easily understood language
    For the treatment of mild 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 19.0
    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 evaluate local cutaneous tolerability of AVX001 3% Ointment (NG) compared to placebo, when topically applied. The two lesions are selected as sites of clinically comparable active dermatitis in two symmetrical anatomical sites in subjects with a definite diagnosis of Atopic Dermatitis according to the Hanifin-Rajka criteria and with any degree of severity of disease, studied in a fourweek period with a two week follow up.
    E.2.2Secondary objectives of the trial
    1. Evaluation of safety profile by recording of adverse events (AEs), clinical laboratory data, and vital signs
    2. Investigators overall clinical assessment of changes in AD
    3. To evaluate therapeutic efficacy based on clinical assessment and objective measures of skin thickness and skin color
    4. To evaluate subject comfort and satisfaction with the ointment
    5. To assess pruritus according to subjects evaluation
    6. To assess a possible appearance of the study drug in plasma
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Following verbal and written information about the trial, subjects must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures
    2. Caucasian male and female Subjects aged 16 years or more with Atopic Dermatitis according to the Hanifin-Rajka criteria and with any degree of severity of disease.
    3. Atopic Dermatitis affecting symmetrical anatomic sites with disease severity mild, moderate and severe AD based on measurement of standard SCORAD
    4. Target lesions (TL) with active dermatitis shall be more than 3 cm in diameter and present at least two of the signs erythema, infiltration and scaliness, in each test site. Symmetrical Target Area’s (TAs) defined as approximately the size of a palm when distributing ointment equivalent to a full fingertip, shall according to Investigator’s spontaneous clinical
    judgement be comparable in disease activity.
    5. Physical examination of the skin must be without abnormal findings other than AD unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical trial.
    E.4Principal exclusion criteria
    1. Any condition in the TAs that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash other than Atopic Dermatitis, hyper- or hypopigmentation, scars.
    2. Any permanent or transient within a 4 weeks period prior to dosing that may interfere with the subjects’ safety or ability to participate in the trial and any condition that according to Investigator’s evaluation may confound or invalidate with clinical assessments and recordings.
    3. Female Subjects must either be of non-childbearing potential (either be surgically sterile (hysterectomy or tubal ligation) or post-menopausal) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, condom with spermicide, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner. Contraception must be maintained from the time of first dosing until 3 months after dosing
    4. Topical treatment of the selected target lesions with topical steroids, topical calcineurin inhibitors (e.g. pimecrolimus, tacrolimus), anti-bacterials or antihistamines 2 weeks prior to dosing
    5. Systemic long term treatments such as azathioprine are allowed provided the dose of such drug is not changed during the study. If changed the investigator shall decide if the change is small and unlikely to influence the study outcome or, alternatively, of a magnitude, which is likely to be of clinically significant influence to target areas.
    6. Phototherapy (e.g. PUVA or UVB) within 4 weeks prior to dosing or during the study treatment phase and extensive sun exposure (e.g. sunbathing, solarium) during the study and 1 week prior to baseline evaluation.
    7. Use of emollients on the TLs within 3 days prior to dosing and during the study treatment phase (note: emollients may be used during the study outside the TLs).
    8. Known or suspected hypersensitivity to component(s) of the investigational product(s).
    9. Subjects known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency, psychological disorder or other conditions)
    10. Females who are pregnant or trying to fall pregnant during the study as well as female that are breast feeding
    11. Participation in another clinical trial within 4 weeks prior to randomization
    12. Subjects previously randomised and dosed in the trial.
    E.5 End points
    E.5.1Primary end point(s)
    Number of subjects experiencing local skin reaction and any other local adverse event at the treated sites (LSRAE) during treatment and follow-up period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of follow-up period
    E.5.2Secondary end point(s)
    1. Assessment of systemic safety based on reported SAE, AE, Laboratory data, vital signs and physical examination
    2. Physician’s Global Assessment of Target Lesion (PGATL) grade 0 to grade 5
    3. Change in the modified SCORAD (SCORing Atopic Dermatitis) clinical score for assessment of severity of dermatitis, in this case adapted to scoring of target lesions. Changes in thickness of the skin lesion based on 20 MHz ultrasound measurement of skin thickening due to inflammatory oedema. Changes in color due to inflammatory vasodilatation based on colorimetri
    4. Subject satisfaction with the ointment (NG) (i.e. Pleasant to use, Spreadability, Greasiness, Stinging/smarting) will be studied using a questionnaire
    5. Subject’s Reported atopic dermatitis-related pruritus using a visual analog scale (VAS )
    6. Plasma concentration above Lower Limit of Quantification (LLOQ) of study drug at the last
    day of treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of treatment or end of follow up
    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 No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Systemic appearance/accumulation
    Patient-reported outcomes (Satisfaction of treatment)
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Parallel treatment in single subject
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 years
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 4
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 4
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state15
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation DanTrials ApS
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-29
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