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    Summary
    EudraCT Number:2016-000556-95
    Sponsor's Protocol Code Number:LP0053-1004
    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:2017-09-12
    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 number2016-000556-95
    A.3Full title of the trial
    LEO 90100 twice weekly maintenance regimen for psoriasis vulgaris
    Zastosowanie LEO 90100 w schemacie dwa razy w tygodniu w leczeniu podtrzymującym u pacjentów z łuszczycą pospolitą.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    LEO 90100 twice weekly maintenance regimen for psoriasis vulgaris
    Zastosowanie LEO 90100 w schemacie dwa razy w tygodniu w leczeniu podtrzymującym u pacjentów z łuszczycą pospolitą.
    A.3.2Name or abbreviated title of the trial where available
    PSO-LONG
    A.4.1Sponsor's protocol code numberLP0053-1004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02899962
    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 pointTamara Yamilee Marotte-Hurbon
    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.5.4Telephone number4531379506
    B.5.6E-mailTBYDK@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 Enstilar(R)
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharma A/S
    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 nameEnstilar / LEO 90100 aerosol foam
    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
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCalcipotriol
    D.3.9.1CAS number 147657-22-5
    D.3.9.3Other descriptive nameCALCIPOTRIOL MONOHYDRATE
    D.3.9.4EV Substance CodeSUB26081
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    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.3.9.3Other 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCutaneous foam
    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
    Łuszczyca pospolita
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    Łuszczyca
    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 efficacy of a twice weekly maintenance regimen with LEO 90100 compared to vehicle in the prevention of relapse in subjects with psoriasis vulgaris.
    Celem pierwszorzędowy jest ocena skuteczności stosowania preparatu LEO 90100 dwa razy w tygodniu w leczeniu podtrzymującym w porównaniu ze stosowaniem podłoża w zapobieganiu nawrotowi choroby u osób z łuszczycą pospolitą.
    E.2.2Secondary objectives of the trial
    • To evaluate the long-term efficacy of LEO 90100 (up to 52 weeks) twice weekly maintenance regimen compared to vehicle in subjects with psoriasis
    • To evaluate the long-term safety of LEO 90100 (up to 52 weeks) in subjects with psoriasis vulgaris
    • Ocena długoterminowego skuteczności stosowania preparatu LEO 90100 (do 52 tygodni) dwa razy w tygodniu w leczeniu podtrzymującym w porównaniu ze stosowaniem podłoża u osób z łuszczycą pospolitą.

    • Ocena długoterminowego bezpieczeństwa stosowania preparatu LEO 90100 (do 52 tygodni) u osób z łuszczycą pospolitą.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - A clinical diagnosis of psoriasis vulgaris for at least 6 months involving the trunk and/or limbs, amenable to treatment with a maximum of 100 g of trial medication per week
    - Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the body surface area (BSA)
    - A target lesion/target location of at least 3 cm at its longest axis located on the body (i.e., not on the scalp, face or intertriginous areas), scoring at least 1 (‘mild’) for each of redness, thickness and scaliness, and at least 4 in total by the Investigator’s Assessment of Severity of the Target Lesion/Location

    For subjects participating in HPA-axis testing furthermore:
    - An extent of psoriasis vulgaris on trunk and/or limbs of disease severity (PGA) of at least ‘moderate’ affecting between 10 and 30% of the body surface area (BSA) excluding psoriatic lesions of genitals and skin folds at Visit 1
    • Stwierdzone klinicznie występowanie łuszczycy pospolitej przez co najmniej 6 miesięcy obejmującej tułów i/lub kończyny, podatnej na leczenie maksymalnie 100 g badanego leku na tydzień
    • Łuszczyca pospolita na tułowiu i/lub kończynach (z wyłączeniem łuszczycy na narządach płciowych i w fałdach skóry) obejmująca 2–30% powierzchni ciała (ang. body surface area, BSA)
    •Zmiana badana o wymiarze co najmniej 3cm w najdłuższej osi, zlokalizowana na skórze gładkiej (poza skórą twarzy, okolicami wyprzeniowymi i skórą owłosioną głowy) osiągająca wartość przynajmniej 1 dla kryterium zaczerwienienia, grubości i złuszczania oraz łączną wartość przynajmniej 4 nasilenia zmian badanych w skali oceny przez badacza.

    Dodatkowe kryteria dla uczestników poddanych badaniu osi podwzgórzowo-przysadkowo-nadnerczowej (ang. Hypothalamic-Pituitary-Adrenal, HPA)
    • Łuszczyca pospolita na tułowiu i/lub kończynach o stopniu nasilenia choroby w skali PGA co najmniej „umiarkowana” obejmująca od 10 do 30% powierzchni ciała z wyłączeniem zmian łuszczycowych narządów płciowych i fałdów skóry podczas wizyty 1.
    E.4Principal exclusion criteria
    - Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to Visit 1:
    • etanercept – within 4 weeks prior to Visit 1
    • adalimumab, infliximab – within 8 weeks prior to Visit 1
    • ustekinumab – within 16 weeks prior to Visit 1
    • secukinumab – within 12 weeks prior to Visit 1
    • other products – within 4 weeks/5 half-lives prior to Visit 1 (whichever is longer)
    - Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g. corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants within 4 weeks prior to Visit 1)
    - Systemic treatment with apremilast within 4 weeks prior to Visit 1
    - Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to Visit 1
    - Ultraviolet B (UVB) therapy within 2 weeks prior to Visit 1
    - Severe and/or extensive scalp psoriasis which, in the opinion of the investigator, requires treatment with potent or super-potent corticosteroids which will be prohibited during the trial

    For subjects participating in HPA-axis testing furthermore:
    - Antidepressive medications within 4 weeks prior to Visit 1 or during the trial. Oestrogen therapy (including contraceptives), antidepressant medications and any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to baseline
    • Leczenie ogólnoustrojowe metodami biologicznymi, niezależnie od tego, czy wprowadzonymi do obrotu, czy nie, o możliwym wpływie na łuszczycę pospolitą w następującym przedziale czasowym przed wizytą 1:
    o etanercept — w ciągu 4 tygodni przed wizytą 1
    o adalimumab, infliksymab — w ciągu 8 tygodni przed wizytą 1
    o ustekinumab — w ciągu 16 tygodni przed wizytą 1
    o secukinumab — w ciągu 12 tygodni przed wizytą 1
    o inne produkty — w ciągu 4 tygodni/5 okresów półtrwania przed wizytą 1 (w zależności od tego, który okres jest dłuższy)
    • Leczenie ogólnoustrojowe wszystkimi innymi metodami o możliwym wpływie na łuszczycę pospolitą (np. z zastosowaniem kortykosteroidów, retinoidów, metotreksatu, cyklosporyny i innych leków immunosupresyjnych) w ciągu 4 tygodni przed wizytą 1
    • Leczenie ogólnoustrojowe apremilastem w ciągu 4 tygodni przed wizytą 1
    • Terapia wykorzystująca psoralen w połączeniu z naświetlaniem promieniami UVA (PUVA) w ciągu 4 tygodni przed wizytą 1
    • Terapia wykorzystująca naświetlanie promieniami UVB w ciągu 2 tygodni przed wizytą 1
    • Ciężka i/lub rozległa łuszczyca skóry głowy, która zdaniem badacza wymaga leczenia silnymi lub bardzo silnymi kortykosteroidami, których stosowanie będzie zabronione podczas badania

    Dodatkowe kryteria wyłączenia dotyczące uczestników poddanych badaniu osi HPA:

    • Leki przeciwdepresyjne w ciągu 4 tygodni przed wizytą 1 lub w trakcie
    badania. Terapia estrogenowa (w tym środki antykoncepcyjne), leki przeciwdepresyjne leki i inne leki wpływające na poziom kortyzolu lub
    Osi HPA w ciągu 4 tygodni przed rozpoczęciem badania.
    E.5 End points
    E.5.1Primary end point(s)
    • Time to first relapse (at least ‘mild’according to the PGA)
    Czas do pierwszego nawrotu (wynik w skali PGA: co najmniej „łagodna”)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Visit 2 (Randomisation) until Visit 15 (End of Treatment)
    Od wizyty 2 (randomizacja) aż do wizyty 15 (Wizyty kończącej leczenie - End of Treatment)
    E.5.2Secondary end point(s)
    • Number of days in remission (‘clear’/‘almost clear’ according to the PGA) during the maintenance phase
    • Number of relapses during the maintenance phase
    • Liczba dni w remisji (wynik „brak zmian” lub „prawie bez zmian” w skali PGA) podczas fazy leczenia podtrzymującego
    • Liczba nawrotów podczas fazy leczenia podtrzymującego
    E.5.2.1Timepoint(s) of evaluation of this end point
    - From Visit 2 (Randomisation) until Visit 15 (End of Treatment)
    - From Visit 2 (Randomisation) until Visit 15 (End of Treatment)
    -Od wizyty 2 (randomizacja) aż do wizyty 15 (Wizyty kończącej leczenie - End of Treatment)

    - Od wizyty 2 (randomizacja) aż do wizyty 15 (Wizyty kończącej leczenie - 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 Yes
    E.6.13.1Other scope of the trial description
    To evaluate the efficacy and safety of twice weekly application as maintenance treatment
    Ocena skuteczności i bezpieczeństwa stosowania dwa razy w tygodniu, jako leczenie podtrzymujące
    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) No
    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 Yes
    E.8.1.7.1Other trial design description
    Przed randomizacją wszyscy uczestnicy badania otrzymają leczenie aktywnym IP raz na dobe przez 4tyg
    Prior to randomisation all subjects receive treatment with active LEO 90100 once daily for 4 weeks
    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.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Canada
    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
    Last Subject Last Visit
    Zakończenie badania definiowane jest, jako ostatnia wizyta ostatniego pacjenta w badaniu, 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 months6
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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.1.2.1Number of subjects for this age range: 700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 132
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 352
    F.4.2.2In the whole clinical trial 832
    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
    brak
    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 Decision2017-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-27
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