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    Summary
    EudraCT Number:2010-021941-38
    Sponsor's Protocol Code Number:LEO 90110-O21
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-11-30
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-021941-38
    A.3Full title of the trial
    LEO 90110 ointment in the treatment of psoriasis vulgaris
    A.4.1Sponsor's protocol code numberLEO 90110-O21
    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 SponsorLEO 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 nameLEO 90110 ointment
    D.3.2Product code LEO 90110 ointment
    D.3.4Pharmaceutical form Ointment
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1035572-38-3
    D.3.9.2Current sponsor codeLEO 29102
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20.0
    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 No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 nameLEO 29102 cream
    D.3.2Product code LEO 29102 cream
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1035572-38-3
    D.3.9.2Current sponsor codeLEO 29102
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 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
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCream
    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
    psoriasis vulgaris
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10050576
    E.1.2Term Psoriasis vulgaris
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare LEO 90110 20.0 mg/g ointment to LEO 90110 ointment vehicle with respect to efficacy when administered twice daily for 8 weeks to patients with psoriasis vulgaris

    E.2.2Secondary objectives of the trial
    To compare LEO 29102 2.5 mg/g cream to LEO 29102 cream vehicle with respect to efficacy when administered twice daily for 8 weeks to patients with psoriasis vulgaris

    To compare LEO 90110 20.0 mg/g ointment to LEO 29102 2.5 mg/g cream with respect to efficacy when administered twice daily for 8 weeks to patients with psoriasis vulgaris

    To investigate the safety of LEO 90110 20.0 mg/g ointment and LEO 29102 2.5 mg/g cream when administered twice daily for 8 weeks to patients with psoriasis vulgaris
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Following verbal and written information about the trial, the subject has provided signed and dated in-formed consent before any study related activity is carried out, including activities relating to the wash-out period
    2. Clinical diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk amenable for topical treatment
    3. Two symmetrically distributed lesions, one on each side of the body, located on arms, legs or trunk, fulfilling the following criteria:
    a. Size
    Each lesion of minimum 0.5% and maximum 1% of total body surface area. The two lesions should be of similar size according to the Investigator’s judge-ment.
    b. Total Clinical Score
    Each lesion with a Total Clinical Score of at least 5. Any difference in Total Clinical Score between the two lesions should be of maximum ‘1’.
    c. Severity
    Severity of each lesion at least mild according to Investigator’s Global Assessment. Severity score must be the same for both lesions.
    4. Aged 18 years or above
    E.4Principal exclusion criteria
    1. Systemic treatment with biological therapies
    directed against or with a potential effect on psoriasis
    vulgaris, within the following time period:
    - etanercept: within 4 weeks prior to randomisation
    - adalimumab, infliximab: within 2 months prior to
    randomisation
    - alefacept, ustekinumab: within 4 months prior to
    randomisation
    2. Systemic treatment with all other than biological
    therapies with a potential effect on psoriasis vulgaris
    (e.g. corticosteroids, retinoids, immunosuppressants,
    salazopyrin) within 4 weeks prior to randomisation
    3. PUVA therapy or Grenz ray therapy within 4
    weeks prior to randomisation
    4. UVB therapy within 2 weeks prior to randomisation
    5. Topical treatment with potent or very potent WHO
    group III and IV corticosteroids within 2 weeks
    prior to randomisation
    6. Any topical treatment (except for emollients) of
    the two selected target lesions within 2 weeks prior
    to randomisation
    7. Planned initiation of, or planned changes to,
    concomitant medication that may affect psoriasis
    vulgaris (e.g., beta blockers, chloroquine, lithium
    and ACE inhibitors) within 2 weeks prior to randomisation
    and during the study
    8. Treatment with drugs sensitive to CYP3A4 or
    CYP2D6 metabolism within 5 half lives prior to randomisation
    9. Current diagnosis of guttate, erythrodermic,
    exfoliative or pustular psoriasis
    10. Any of the following conditions present on the two
    selected target lesions: Infectious skin disorder,
    eczematous skin, atopic dermatitis, ulcers or wounds
    11. Skin disease on the two selected target lesions that
    may confound the evaluation of psoriasis vulgaris
    (e.g., seborrhoiec dermatitis, contact dermatitis or
    fungal infection) as judged by the Investigator
    12. Planned exposure to the sun during the study that
    may affect psoriasis vulgaris (i.e., normal lifestyle
    outdoor activities are permitted but deliberate exposure
    to sunlight or artificial ultraviolet light to the
    two selected target lesions should be avoided)
    13. Clinically significant cardiac, endocrinologic,
    pulmonary, neurologic, psychiatric, hepatic, renal,
    haematologic, malignant or gastrointestinal disease,
    immunologic insufficiency, or other major diseases
    or current condition which, in the opinion of the
    Investigator, would put the subject at risk by participating
    in the study or would interfere with the
    evaluation of study results
    14. History of immune deficiency condition (e.g.,
    lymphoma, HIV or Wiskott-Aldrich Syndrome)
    15. Chronic or ongoing infectious disease requiring
    systemic treatment such as, but not limited to,
    chronic renal infection, chronic chest infection with
    bronchiectasis, tuberculosis, active hepatitis B, active
    hepatitis C, HIV positive
    16. Known or suspected hypersensitivity to component(
    s) of the investigational products
    17. Current participation in any other interventional
    clinical trial
    18. Treatment with any non-marketed drug substance
    (i.e., an agent which has not yet been made available for clinical use following registration) within the last
    4 weeks prior to randomisation, or for biologics,
    within the last 12 weeks prior to randomisation
    19. Previously randomised in this trial
    20. Known or suspected to be unlikely to comply with
    the Clinical Study Protocol (e.g., due to alcoholism,
    drug dependency or psychotic state)
    21. Female subjects who are pregnant, of child-bearing
    potential and wishing to become pregnant during the
    trial, or are breast feeding
    22. Female subjects of childbearing potential1 expected
    not using an adequate method of contraception during
    the study and during 4 weeks after last administration
    of investigational product. Adequate methods
    of contraception are defined as
    - abstinence (when this is in line with the preferred
    and usual lifestyle of the subject)
    - vasectomised partner (partner should be the sole
    partner for the subject)
    - an intrauterine device
    - double barrier method defined as two distinct
    methods (either two actual barrier methods or one
    actual barrier method and one hormonal method)
    - hormonal contraceptive (oral hormonal birth control,
    estrogenic vaginal ring, percutaneous contraceptive
    patches, implants and injectables) for at least
    one menstrual cycle prior to randomisation (Visit 1)
    E.5 End points
    E.5.1Primary end point(s)
    The absolute change in Total Clinical Score from baseline (Visit 1) to 8 weeks of treatment (end of treatment, Visit 7) for the selected target lesion on the left and right side of the body
    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 Yes
    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 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) Yes
    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 concerned8
    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 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 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
    Please refer to Protocol Version 29-Oct-2010
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 88
    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 Decision2010-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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