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    Summary
    EudraCT Number:2013-001538-16
    Sponsor's Protocol Code Number:LP0076-1017
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-10-26
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2013-001538-16
    A.3Full title of the trial
    Effect of Calcipotriol plus Betamethasone Dipropionate Gel on the HPA Axis and Calcium Metabolism in Adolescent Subjects (Aged 12 to 16 Years, 11 months) with Scalp and Body Psoriasis

    A phase 2 trial evaluating the safety and efficacy of once daily use of LEO 80185 gel containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) in adolescent subjects (aged 12 to 16 years, 11 months) with scalp and body psoriasis

    An international, multi-centre, prospective, non-controlled, open, single-group, 8-week trial in adolescent subjects (aged 12 to 16 years, 11 months) with scalp and body psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of Calcipotriol plus Betamethasone Dipropionate Gel in Adolescent Subjects (Aged 12 to 16 Years, 11 months) with Scalp and Body Psoriasis
    A.3.2Name or abbreviated title of the trial where available
    Not Applicable
    A.4.1Sponsor's protocol code numberLP0076-1017
    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 A/S
    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 codeDK-2750
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4572262450
    B.5.5Fax number+4572263321
    B.5.6E-mailaruna.sharma@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 Yes
    D.2.1.1.1Trade name Dovobet® 50 mcg/g + 0.5 mg/g gel
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharma A/S, Ballerup, Denmark
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    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
    Psoriasis of the scalp and body
    E.1.1.1Medical condition in easily understood language
    Psoriasis of the scalp and body
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    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 calcipotriol (50 mcg/g) plus betamethasone (0.5 mg/g) (as dipropionate) gel in adolescent subjects (aged 12 to 16 years, 11 months) with scalp and body psoriasis.
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the efficacy of once daily use of calcipotriol (50 mcg/g) plus betamethasone (0.5 mg/g) (as dipropionate) gel in adolescent subjects (aged 12 to 16 years, 11 months) with scalp and body psoriasis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria for All Subjects:
    1. Signed informed consent given by parent(s), or legal guardian(s), or by the subject (according to national law) following their receipt of verbal and written information about the trial.
    2. Subjects will receive verbal and written information and will provide written assent to the trial.
    3. Subjects 12 to 16 years, 11 months of age.
    4. Either sex.
    5. Any race or ethnicity.
    6. Clinical signs of psoriasis vulgaris on both the scalp and body (trunk and/or limbs).
    7. A serum albumin-corrected calcium below the upper reference limit at SV2.
    8. Females of child-bearing potential must have a negative urine pregnancy test result and must agree to use a highly effective method of contraception during the trial. Highly effective methods are defined as ones which result in a low failure rate (less than 1% per year) such as progestin-only formulations (implants, injectables, or “mini-pill” in combination with a barrier method), some intra-uterine devices, double barrier methods (eg. cervical cap and condom), tubal ligation/section, sexual abstinence or vasectomised partner. The patients must have used the contraceptive method for at least 1 month prior to the pregnancy test at SV2, and must continue using the contraceptive method for at least 1 week after the last application of investigational product. A female is defined as not of child-bearing potential if she is premenarchal, postmenopausal or surgically sterile (hysterectomy or bilateral ovariectomy).
    9. Subjects fulfilling national requirements/law for participation in this trial.

    Additional Inclusion Criteria for Subjects Performing HPA Axis
    and PK Assessments (assigned U.S. sites only):
    10. At SV2 and Visit 1, a clinical diagnosis of scalp and body (trunk and/or limbs) psoriasis which is:
    a. of an extent of 10 to 35% of the body surface area (excluding psoriatic lesions of the face and sensitive areas), and
    b. of at least moderate severity according to the investigator’s global assessment of disease severity on the body
    11. At SV2 and Visit 1, a clinical diagnosis of scalp psoriasis which is:
    a. more than or equal to 20% of the scalp area, and
    b. of at least moderate severity according to the investigator’s global assessment of disease severity on the scalp.
    12. Subjects with a normal HPA axis function at SV2 including serum cortisol concentration above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH challenge.
    13. At Visit 1, weighing at least 30kg

    Additional Inclusion Criteria for Subjects Not Performing HPA
    Axis and PK Assessments:
    14. At SV2 and Visit 1, a clinical diagnosis of body (trunk and/or limbs) psoriasis which is:
    a. more than or equal to 3% of the body surface area (excluding psoriatic lesions of the face and sensitive areas), and
    b. of at least mild severity according to the investigator’s global assessment of
    disease severity on the body.
    15. At SV2 and Visit 1, a clinical diagnosis of scalp psoriasis which is:
    a. more than or equal to 10% of the scalp area, and
    b. of at least mild severity according to the investigator’s global assessment of
    disease severity on the scalp, and
    c. for subjects aged 12 to < 15 years with a BSA ≤ 1.3 m2, amenable to topical
    treatment with a maximum of 55 g of investigational product per week, and
    d. for subjects aged 12 to < 15 years with a BSA > 1.3 m2, amenable to topical
    treatment with a maximum of 75 g of investigational product per week, and
    e. for subjects aged > 15 years with a BSA ≤ 1.7 m2, amenable to topical treatment with a maximum of 75 g of investigational product per week, and
    f. for subjects aged > 15 years with a BSA > 1.7 m2, amenable to topical treatment with a maximum of 100 g of investigational product per week.
    E.4Principal exclusion criteria
    1. A history of hypersensitivity to any component of the LEO 80185 gel
    2. 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 Visit 1 and during the trial:
    a. etanercept – within 4 weeks prior to Visit 1
    b. adalimumab, infliximab – within 2 months prior to Visit 1
    c. ustekinumab – within 4 months prior to Visit 1
    d. experimental products – within 4 weeks/5 half-lives prior to Visit 1
    3. Systemic treatment with therapies other than biologicals, with a possible effect on scalp and/or body psoriasis (e.g., retinoids, immunosuppressants, PUVA) within 4 weeks prior to Visit 1 (Day 0) or during the trial.
    4. UVB therapy within 2 weeks prior to Visit 1 or during the trial.
    5. Any topical treatment on the scalp and body including corticosteroids (except for emollients and non-steroid medicated shampoos) within 2 weeks prior to Visit 1 or during the trial.
    6. Systemic calcium, vitamin D supplementation > 400 IU/day, antacids, diuretics, antiepileptics, diphosphonates or calcitonin within 4 weeks prior to SV2 or during the trial.
    7. Planned initiation of, or changes to, concomitant medication that could affect psoriasis (e.g., betablockers, chloroquine, lithium, ACE inhibitors) during the trial.
    8. Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
    9. Subjects with any of the following conditions present on the treatment areas on scalp and/or body: viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds.
    10. Other inflammatory skin diseases that may confound the evaluation of scalp and/or body psoriasis.
    11. Planned excessive exposure to sun during the trial that may affect scalp and/or body psoriasis.
    12. Known or suspected severe renal insufficiency or severe hepatic disorders.
    13. Known or suspected disorders of calcium metabolism associated with hypercalcaemia.
    14. Any clinically significant abnormality following review of screening laboratory tests (blood and urine samples), physical examination or blood pressure/heart rate measurement performed at SV2.
    15. Current participation in any other interventional clinical trial.
    16. Previously treated with LEO80185 in this trial.
    17. Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within a month prior to SV1 or longer, if the class of substance required a longer wash-out as defined above (e.g., biological treatments).
    18. Subjects or parent(s) or legal guardian known or suspected of being unlikely to comply with the Clinical Trial Protocol (e.g., alcoholism, drug dependency or psychotic state).
    19. Females who are pregnant, or of child-bearing potential and wishing to become pregnant during the trial, or who are breast-feeding.
    20. Females of child-bearing potential with positive pregnancy test at SV2.
    21. Subject (or their partner) not using an adequate method of contraception according to national requirements.
    22. A history of serious allergy, allergic asthma or serious allergic skin rash.
    23. Known or suspected hypersensitivity to any component of CORTROSYN® (including ACTH/cosyntropin/tetracosactide)
    24. Systemic treatment with corticosteroids (including inhaled and nasal steroids) within 12 weeks prior to SV2 or during the trial.
    25. Oestrogen therapy (including contraceptives) or any other medication known to affect cortisol levels levels or HPA axis integrity within 4 weeks prior to SV2 or during the trial.
    26. Enzymatic inductors (e.g., barbiturates, phenytoin, rifampicin) within 4 weeks prior to SV2 or during the trial.
    27. Systemic or topical cytochrome P450 inhibitors (e.g., ketoconazole, itraconazole, metronidazole) within 4 weeks prior to SV2 or during the trial. Topical ketoconazole 2 weeks prior to SV2.
    28. Hypoglycemic sulfonamides within 4 weeks prior to SV2 or during the trial.
    29. Antidepressive medications within 4 weeks prior to SV2 or during the trial.
    30. Known or suspected endocrine disorder that may affect the results of the ACTH challenge test.
    31. Clinical signs or symptoms of Cushing’s disease or Addison’s disease.
    32. Subjects with diabetes mellitus.
    33. Known or suspected cardiac condition.
    34. Not following nocturnal sleep patterns.
    35. Topical treatment on the face and/or sensitive areas (armpits, groin, under the breasts and in other skin folds around the genitals and buttocks) with potent or very potent (WHO groups III-IV) corticosteroids within 2 weeks prior to Visit 1 or during the trial.
    E.5 End points
    E.5.1Primary end point(s)
    Adverse drug reactions (ADRs)
    • Subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4 and at Week 8
    • Change in albumin-corrected serum calcium from baseline (SV2) to Week 4, Week 8, and end of treatment
    • Change in 24-hour urinary calcium excretion from baseline (SV2) to Week 4, Week 8, and end of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    Adverse drug reactions (ADRs)
    • Subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4 and at Week 8
    • Change in albumin-corrected serum calcium from baseline (SV2) to Week 4, Week 8, and end of treatment
    • Change in 24-hour urinary calcium excretion from baseline (SV2) to Week 4, Week 8, and end of treatment
    E.5.2Secondary end point(s)
    • Adverse events (AEs)
    • Subjects with serum cortisol concentration of ≤18 mcg/dl at both 30 and 60 minutes after ACTH-challenge at Week 4 and at Week 8
    • Change in urinary calcium:creatinine ratio from baseline (SV2) to Week 4 and Week 8
    • Change in serum alkaline phosphate (ALP) from baseline (SV2) to Week 4 and Week 8
    • The following PK parameters calculated at Week 4 for each assayed compound:
    o AUC 0-t
    o AUC 0-∞
    o C max
    o T max
    o T 1/2
    • Subjects with “Controlled disease” (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 investigator’s global assessment of
    • Percentage change in PASI from baseline to end of treatment.
    • Subjects with “Controlled disease” (i.e., “Clear” or “Very mild”) according to the patient’s global assessment of disease severity on the body at end of treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Adverse events (AEs)
    • Subjects with serum cortisol concentration of ≤18 mcg/dl at both 30 and 60 minutes after ACTH-challenge at Week 4 and at Week 8
    • Change in urinary calcium:creatinine ratio from baseline (SV2) to Week 4 and Week 8
    • Change in serum alkaline phosphate (ALP) from baseline (SV2) to Week 4 and Week 8
    • PK parameters calculated at Week 4 for each assayed compound.
    • Subjects with “Controlled disease” (i.e., “Clear” or “Almost clear”) according to the investigator’s global assessment of
    • Percentage change in PASI from baseline to end of treatment.
    • Subjects with “Controlled disease” (i.e., “Clear” or “Very mild”) according to the patient’s global assessment of disease severity on the body at end of treatment.
    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 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.8.3 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Australia
    Canada
    France
    Germany
    New Zealand
    Poland
    Romania
    United Kingdom
    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
    LVLS
    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 months8
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days28
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    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)
    None
    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 Decision2015-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-26
    P. End of Trial
    P.End of Trial StatusOngoing
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