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    Summary
    EudraCT Number:2005-000842-35
    Sponsor's Protocol Code Number:BT0500INT001
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-10-18
    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 ConcernedSweden - MPA
    A.2EudraCT number2005-000842-35
    A.3Full title of the trial
    A randomized, double-blind, multinational, multicenter, placebo-controlled parallel phase II/III trial to evaluate the efficacy and safety of 2 doses of oral liarozole (75 mg o.d. and 150 mg o.d.) given during 12 weeks in comparison with placebo in the treatment of subjects with lamellar ichthyosis.
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and safety of two doses of liarozole vs. placebo for the treatment of lamellar ichthyosis.
    A.4.1Sponsor's protocol code numberBT0500INT001
    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 SponsorBarrier Therapeutics, Inc.
    B.1.3.4CountryUnited States
    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 Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/03/144
    D.3 Description of the IMP
    D.3.1Product nameLiarozole
    D.3.2Product code R085246
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNLiarozole fumarate
    D.3.9.1CAS number 145858-52-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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
    Lamellar Ichthyosis
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of oral liarozole, at a dose of 75 mg o.d. or 150 mg o.d. vs. placebo in the treatment of lamellar ichthyosis, as measured by the Investigator's Global Assessment at the end of 12 weeks of treatment.
    E.2.2Secondary objectives of the trial
    Include comparisons between liarozole and placebo on:
    · Overall Scaling Score
    · Severity scores of erythema and pruritus
    · Investigator’s Global Assessment at week 8
    · Quality of Life (SF-36; DLQI/CDLQI)
    · Photographs
    · Safety and tolerability
    · Use of emollients and mechanical scale removal
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Subjects of either sex aged 14 years or older
    2. Clinical diagnosis of lamellar ichthyosis with at visits 1 and 2 an Investigator’s Global Assessment of at least 3 when defined as follows:
    Investigator’s global assessment of the overall severity of subject’s lamellar ichthyosis at a particular time point, taking into consideration the two individual characteristics of ichthyosis (scaling and/or erythema), measured by the following 5-point Likert scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe).
    3. Body weight of at least 45 kg (99 lbs).
    4. Women of childbearing potential are asked to use simultaneously 2 forms of effective contraception during the trial. The first one must be a hormonal contraceptive containing an association of progestin and estrogen and must be taken for at least 1 month (full cycle) before the start of treatment (visit 2). The second one must be a barier method with spermicide and must be used at least from visit 1. Both forms must then be used during treatment and until one month after the end of the treatment period.
    5. Women of childbearing potential should have a negative pregnancy test at screening visit (Visit 1), confirmed by another pregnancy test on the 2nd or 3rd day of their next menses (Visit 2).
    6. Subjects are, except for their lamellar ichthyosis, in good general health and free of any disease state or physical condition that, in the investigator’s opinion, might impair evaluation of their lamellar ichthyosis.
    7. Subjects and legal representative(s), if applicable, signed informed consent.
    E.4Principal exclusion criteria
    1. Concurrent inflammatory skin disease unrelated to ichthyosis.
    2. Subject is receiving topical (except emollient) or UV treatment for ichthyosis in the 2 weeks prior to the start of treatment (Visit 2).
    3. Subject is receiving systemic therapy for ichthyosis in the 4 weeks prior to the start of treatment (Visit 2).
    4. Subject is pregnant or breast feeding.
    5. Girls that have not had their first full menstruation cycle.
    6. History or suspicion of alcohol or drug abuse.
    7. Significant co-existing hepatic, renal, immune disease, chronic pancreatitis, osteoporosis or a history indicating adrenal cortex dysfunction.
    8. Heart disorder requiring treatment, or a myocardial infarction within the previous 24 weeks or a history of heart-failure or clinically relevant cardiac arrhythmia.
    9. Clinically significant abnormal electrocardiogram-intervals or morphology of the electrocardiogram; QT or QTc >470 ms in women or >450 ms in men.
    10. History of hypersensitivity to retinoids.
    11. History of hypersensitivity to any of the ingredients in the trial medication.
    12. Clinically relevant laboratory abnormalities at screening, especially levels of blood triglycerides, cholesterol and liver function parameters.
    13. Use of Vitamin A supplements in the 4 weeks prior to the start of treatment or during the trial.
    14. Use of drugs metabolized by the CYP450 system at visit 2.
    15. Use of immune-suppressive drugs including topical or systemic corticosteroids.
    16. Participation in an investigational trial 30 days prior to the start of the trial (Visit 1).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the percentage of responders to treatment. A subject is considered a responder if the Investigator's Global Assessment is decreased with at least 2 points on the 5-point Likert scale by the end of the treatment period.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) Yes
    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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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.1.2Adults (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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-10-18. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects less than 18 years old
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 78
    F.4.2.2In the whole clinical trial 98
    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 Decision2005-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
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