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    Summary
    EudraCT Number:2006-001062-17
    Sponsor's Protocol Code Number:ASF-1096-201/250912BS
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-07-22
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-001062-17
    A.3Full title of the trial
    Efficacy and safety of ASF-1096 cream 0.5% in the treatment of patients with newly developed discoid lupus erythymatosus (DLE) lesions. A multi centre clinical phase 2, placebo controlled and double blind proof of concept study.
    A.3.2Name or abbreviated title of the trial where available
    Lupus study
    A.4.1Sponsor's protocol code numberASF-1096-201/250912BS
    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 Danmark 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-1096 cream 0.5%
    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-1096
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 typeSulphate salt of R-salbutamol
    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
    Male or female patients with a clinical diagnosis of either Discoid Lupus Erythmatosus or Systemic Lupus Erythmatosus and at least one newly developed, sharply demarcated DLE lesion.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10025138
    E.1.2Term Lupus erythematosus discoides
    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 compare the treatment effect of ASF-1096 cream 0.5% to ASF-1096 Cream Placebo on a newly developed DLE lesion after 8 weeks of twice daily, topical treatment.
    E.2.2Secondary objectives of the trial
    To compare the treatment effect of ASF-1096 cream 0.5% to ASF-1096 cream placebo with regard to the response/rating on/of:
    •Erythema
    •Scaling/hypertrophy
    •Dyspigmentation
    •Scarring/Atrophy/Panniculitis
    •Induration
    •Pain
    •Itching
    •Lesion area
    •General improvement assessed by the investigator
    •Global improvement assessed by the patient after 2, 4, 6 and 8 weeks of treatment.
    To compare and describe the safety profile in the ASF-1096 cream 0.5% and ASF-1096 cream placebo groups.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All of the following criteria have to be met for inclusion of a patient in the study:
    •Patients of any gender aged from 18 to 70 years;
    •A clinical diagnosis of either DLE or SLE;
    •At least one newly developed, sharply demarcated DLE lesion (target lesion) with erythema score > 1 and scaling score > 1;
    •Histological results from biopsy confirming the diagnosis will be obtained at the beginning of the study, in case histological results confirming the diagnosis are available a new biopsy is not needed;
    •The physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
    •Sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen for at least 12 weeks prior to the study, during the study and one month after the end of the study; systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (IUD), condom with intravaginal spermicide;
    •Willing and able to comply to the study procedures;
    •Prepared to grant authorised persons access to the medical records;
    •Signed informed consent.
    E.4Principal exclusion criteria
    Patients will not be included in the study when one or more of the following conditions are met:
    •Active skin disease other then DLE or another progressive or serious disease that interferes with the study outcome;
    •Scarring at the target lesion;
    •Keratonisation of treated lesion;
    •Concomitant, or within four weeks prior to dosing, treatment with corticosteroids (local or systemic), anti-malarials, retinoids or thalidomide;
    •Systemic treatment of SLE;
    •Concomitant, or within four weeks prior to dosing, treatment with medicinal products containing salbutamol (local or systemic);
    •Symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
    •Participation in another clinical trial, including the four week period preceding the study;
    •Known allergic reactions to components of the study preparations;
    •Pregnancy (according to pregnancy test) or nursing.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint for this study is the efficacy of ASF-1096 cream 0.5% compared to the ASF-1096 cream placebo using the area under the curve (AUC) of the local CLASI score.
    For analysis of the primary end point the null hypothesis
    H0: The mean AUCs of the local CLASI score in the groups treated with ASF-1096 cream 0.5% and the ASF-1096 cream placebo are the same.
    will be tested versus the alternative hypothesis
    H1: The mean AUCs of the local CLASI score in the groups treated with ASF-1096 cream 0.5% and the ASF-1096 cream placebo are not the same.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Yes
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    The end of the trial is the last visit of the last subject undergoing the trial. In the case of premature termination for any reason in a patient, the patient will be asked to do the End of Trial visit.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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) Yes
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 32
    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)
    After the patients have ended the participation in the trial a normal treatment of that condition which is not part of the study can be performed.
    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 Decision2006-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-07-27
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