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    Summary
    EudraCT Number:2007-003212-65
    Sponsor's Protocol Code Number:ASF-1075-205
    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:2007-07-05
    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 number2007-003212-65
    A.3Full title of the trial
    Efficacy and safety of ASF-1075 cream 5% on pruritus in adult patients with atopic dermatitis. A multi-centre, randomised, double-blind, vehicle-controlled, parallel groups, proof of concept study.
    A.4.1Sponsor's protocol code numberASF-1075-205
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstion Pharma A/S
    B.1.3.4CountryDenmark
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameASF-1075 Cream 5%
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeASF-1075
    D.3.9.3Other descriptive namemonoethanolamine salt of oxaprozine
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typemonoethanolamine salt of oxaprozin
    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 placeboCream
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Caucasian male and female patients 18-65 years of age with mild to moderate atopic dermatitis and experiencing moderate to severe pruritus.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10012438
    E.1.2Term Dermatitis atopic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to investigate the treatment effect of ASF-1075 cream 5% on pruritus in adult patients with mild to moderate atopic dermatitis following 3 weeks randomised double blind vehicle controlled treatment with up to maximum 5 times daily application.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    • To investigate the treatment effect of ASF-1075 cream 5% with regard to:
    o Atopic dermatitis signs and symptoms other than pruritus
    o Clinical score - EASI
    o Global improvement assessed by the investigator
    o Global improvement assessed by the patient
    o Patient assessed quality of life
    • To assess the safety and local tolerance profile in the ASF-1075 cream 5% group
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Caucasian male and female patients 18-65 years of age with mild to moderate atopic dermatitis (AD) and experiencing moderate to severe pruritus defined as at least 30 mm using the VAS. In total 40 subjects (20 in each group) will be randomized.
    A subject will be eligible for inclusion in this trial only if all of the following criteria apply:
    • Caucasian male or female patient 18 to 65 years of age
    • A clinical diagnosis of Atopic Dermatitis according to the criteria of Hanifin and Rajka7 and rated as mild to moderate with up to 15% involvement of total body area
    • Intermittent pruritus
    • Pruritus (overall pruritus over the last 24 hours) rated at the baseline visit as moderate intensity, i.e. at least 30 mm using the 100 mm VAS
    • Females of childbearing potential should either be clinically sterile (postmenopausal 12 months, hysterectomy or tubal ligation) or use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with spermicide, intrauterine device (IUD), condom with intra-vaginal spermicide
    • Willing and able to comply with the study procedures
    • Signed informed consent according to ICH GCP and local regulation
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this trial if any of the following criteria applies:
    • Pregnant, breast feeding female or female planning to become pregnant during the study
    • Impetiginised atopic dermatitis (AD)
    • Active skin disease other than AD, which in the opinion of the investigator will interfere with evaluation of efficacy or safety or another progressive or serious disease that may interfere with the study outcome, specifically:
    o Active skin disease other than AD e.g. seborrhoeic dermatitis, active infection, nummular eczema
    o Any immunocompromised disease e.g. HIV
    o Severe hepatic disease
    o Severe renal disease
    • Topical treatments of atopic dermatitis;
    o Corticosteroids, immunomodulators (calcineurin inhibitors: pimecrolimus, tacrolimus), antihistamines, antibiotics or NSAIDs in the 2 weeks prior to the baseline visit.
    o UV therapy during the last 4 weeks
    • Systemic medications which may interfere with the evaluation of anti pruritic effect, or which may influence the severity of disease:
    o Antibiotics, antihistamines, NSAIDs or aspirin in the 2 weeks prior to the baseline visit
    o Corticosteroids (including inhalation), immunomodulators, immunosuppressants, cytostatics, retinoids, anti-malaria, anti psychotic triclyclic antidepreeants, or benzodiazepines during the last 4 weeks prior to the baseline visit.
    • Symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study
    • Physical examination with disease findings considered, at the discretion of the investigator, to be relevant to the outcome of the study
    • Known allergic reactions to components of the study preparations or to NSAIDs
    • Must not be enrolled in another investigational drug study in the last 3 months prior to the baseline visit.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is pruritus due to atopic dermatitis (AD) evaluated in the clinic using a 100 mm visual analogue scale (VAS) after 3 weeks treatment compared to baseline.

    The secondary endpoints are:
    • Pruritus due to AD after 1 and 2 weeks treatment compared to baseline assessed in the clinic using the 100mm VAS.
    • Effect on patient daily reported pruritus in a diary, using average for the last three days within each week, at baseline and at 1, 2 and 3 weeks using the 4-point verbal rating scale according to EASI.
    • Onset of effect using the above mentioned diary data
    • Clinical score using Eczema Area and Severity Index (EASI).
    • Investigator’s Global Assessment (IGA) of AD on a 6-point verbal rating scale.
    • Patient’s Global Assessment of AD on a 4-point verbal rating scale.
    • Number of applications in the two groups during week 1.
    • Quality of Life assessed by the patient using the DLQI.
    • Adverse events.
    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 No
    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 No
    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.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA3
    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 Information not present in EudraCT
    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
    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 months
    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 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.1.3Elderly (>=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 state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 40
    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 Decision2007-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2025-01-30
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