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    Summary
    EudraCT Number:2015-000839-33
    Sponsor's Protocol Code Number:LP0053-1108
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-25
    Trial results View 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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-000839-33
    A.3Full title of the trial
    Safety and Effect of LEO 90100 aerosol foam on the HPA Axis and Calcium Metabolism in Adolescent Subjects (Aged 12 to < 17 Years) with Plaque Psoriasis
    A phase 2 trial evaluating the safety and efficacy of once daily topical treatment with LEO 90100 aerosol foam in adolescent subjects with plaque psoriasis
    An international, multi-centre, prospective, open-label, non-controlled, single-group,
    4-week trial in adolescent subjects with plaque psoriasis




    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research Study to evaluate the efficacy and safety of LEO 90100 aerosol foam for adolescent patients with plague psoriasis
    A.4.1Sponsor's protocol code numberLP0053-1108
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02387853
    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 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 supportLEO Pharma A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLEO Pharma
    B.5.2Functional name of contact pointGlobal Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressIndustriparken 55
    B.5.3.2Town/ cityBallerup
    B.5.3.3Post code2750
    B.5.3.4CountryDenmark
    B.5.6E-mailjulia.delfs@leo-pharma.com
    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 90100
    D.3.2Product code LEO 90100
    D.3.4Pharmaceutical form Cutaneous foam
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    Topical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCalcipotriol Hydrate
    D.3.9.1CAS number 147657-22-5
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameCALCIPOTRIOL MONOHYDRATE
    D.3.9.4EV Substance CodeSUB26081
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbetamethasone Dipropionate
    D.3.9.1CAS number 5593-20-4
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameBETAMETHASONE DIPROPIONATE
    D.3.9.4EV Substance CodeSUB00783MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Plague Psoriasis
    E.1.1.1Medical condition in easily understood language
    Psoriasis is an immunologic disease causing inflammation, scaling and redness of the skin of the skin, located mainly on the scalp, sides of elbows and knees, and the sacral region ..
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10050576
    E.1.2Term Psoriasis vulgaris
    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
    The primary objective is to evaluate the safety of once daily use of LEO 90100 in adolescent subjects (aged 12 to < 17 years) with plaque psoriasis on the body and scalp.
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the efficacy of once daily use of LEO 90100 in adolescent subjects (aged 12 to < 17 years) with plaque psoriasis on the body and scalp.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adolescent subjects (age 12 to 16 years, 11 months).
    • Plaque psoriasis on trunk and/or limbs affecting at least 2% BSA.
    • Plaque psoriasis on the scalp affecting at least 10% of total scalp area.
    • A total psoriatic involvement on trunk, limbs and scalp not exceeding 30% BSA.
    • PGA score of at least mild on trunk and/or limbs at SV1, SV2 and V1.
    • PGA score of at least mild on scalp at SV1, SV2 and V1.
    • A serum albumin-corrected calcium below the upper reference limit at SV2.
    • Female subjects must be of either
    • non-childbearing potential, i.e. premenarchal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal litigation) or,
    • child-bearing potential provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy.
    • Female subjects of child-bearing potential must be willing to use highly effective contraception at trial entry and until completion.

    30 evaluable subjects without adrenal suppression at baseline will undergo an ACTH-challenge test (Visit 3) and PK assessments (Visit 2 and Visit 3).
    The ACTH-challenge test as well as PK assessments will only be performed at assigned sites and countries.
    E.4Principal exclusion criteria
    • A history of hypersensitivity to any component of LEO 90100.
    • Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp and/or body psoriasis within the following time period prior to V1 and during the trial:
    a. etanercept – within 4 weeks prior to V1
    b. adalimumab, infliximab – within 2 months prior to V1
    c. ustekinumab – within 4 months prior to V1
    d. experimental products – within 4 weeks/5 half-lives (whichever is longer) prior to V1
    • Systemic treatment with therapies other than biologicals, with a possible effect on scalp and/or body psoriasis (e.g. methotrexate, retinoids, immunosuppressants) within 4 weeks prior to V1 or during the trial.
    • PUVA therapy within 4 weeks prior to V1.
    • UVB therapy within 2 weeks prior to V1 or during the trial.
    • Any topical treatment on the scalp and body including corticosteroids and vitamin D (except for emollients and non-steroid medicated shampoos) within 2 weeks prior to V1 or during the trial.
    • Systemic calcium, vitamin D supplementation > 400 IU/day, antacids, diuretics, antiepileptics, diphosphonates or calcitonin within 4 weeks prior to SV2 or during the trial. (note: stable dose of vitamin D supplementation ≤ 400 IU/day is permitted provided there are no dose adjustments during the study period).
    Additional exclusion criteria for subjects undergoing HPA axis testing:
    A history of serious allergy, allergic asthma or serious allergic skin rash.
    Known or suspected hypersensitivity to any component of CORTROSYN® (including ACTH/cosyntropin/tetracosactide)
    Systemic treatment with corticosteroids (including inhaled and nasal steroids) within 12 weeks prior to SV2 or during the trial.
    Oestrogen therapy (including contraceptives) or any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to SV2 or during the trial.
    Enzymatic inductors (e.g., barbiturates, phenytoin, rifampicin) within 4 weeks prior to SV2 or during the trial.
    Systemic or topical cytochrome P450 inhibitors (e.g., ketoconazole, itraconazole,metronidazole) within 4 weeks prior to SV2 or during the trial. Topical ketoconazole within 2 weeks prior to SV2.
    Hypoglycemic sulfonamides within 4 weeks prior to SV2 or during the trial.
    Antidepressive medications within 4 weeks prior to SV2 or during the trial.
    Known or suspected endocrine disorder that may affect the results of the ACTH challenge test.
    Clinical signs or symptoms of Cushing’s disease or Addison’s disease.
    Subjects with diabetes mellitus.
    Known or suspected cardiac condition.
    Not following nocturnal sleep patterns.
    E.5 End points
    E.5.1Primary end point(s)
    • Adverse events (AEs)
    • Subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4
    • Change in albumin-corrected serum calcium from baseline (SV2) to Week 4
    • Change in calcium excretion from baseline (SV2) to Week 4 in 24-hour urine
    • Change in calcium:creatinine ratio from baseline (SV2) to Week 4 in 24-hour urine
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    E.5.2Secondary end point(s)
    • Subjects with serum cortisol concentration of ≤18 mcg/dl at both 30 and 60 minutes after ACTH-challenge at Week 4
    • Change in calcium:creatinine ratio from baseline (SV2) to Week 4 in spot urine
    • Subjects with ‘treatment success’ (i.e., ‘clear’ or ‘almost clear’ for subjects with at least ‘moderate’ disease at baseline, ‘clear’ for subjects with ‘mild’ disease at baseline) according to the physician´s global assessment of disease severity on the body at Week 4
    • Subjects with ‘treatment success’ (i.e., ‘clear’ or ‘almost clear’ for subjects with at least ‘moderate’ disease at baseline, ‘clear’ for subjects with ‘mild’ disease at baseline) according to the physician´s global assessment of disease severity on the scalp at Week 4
    • Percentage change in psoriasis area and severity index (PASI) from baseline (V1) to Week 4
    • Subjects with ‘treatment success’ (i.e., ‘clear’ or ‘very mild) according to the subject´s global assessment of disease severity on the body at Week 4
    • Subjects with ‘treatment success’ (i.e., ‘clear’ or ‘very mild) according to the subject´s global assessment of disease severity on the scalp at Week 4
    • Change in itch as assessed by the Visual Analogue Scale (VAS) from baseline (V1) to Week 4
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    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 Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Netherlands
    Poland
    Romania
    United States
    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
    LVLP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 100
    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: 100
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Adolescents (12-17 years)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 100
    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)
    NA
    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 Decision2016-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-28
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