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    Summary
    EudraCT Number:2020-004561-39
    Sponsor's Protocol Code Number:LP0190-1488
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-25
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-004561-39
    A.3Full title of the trial
    A phase 2 trial to evaluate the efficacy and safety of orally administered LEO 152020 tablets compared with placebo tablets for up to 16 weeks of treatment in adults with moderate to severe atopic dermatitis
    Ensayo fase 2 para evaluar la eficacia y seguridad de los comprimidos de LEO 152020 administrados por vía oral en comparación con los comprimidos de placebo durante un período de hasta 16 semanas de tratamiento en adultos con dermatitis atópica de moderada a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2 trial to evaluate the efficacy and safety of orally-administered LEO 152020 tablets compared with placebo tablets for up to 16 weeks of treatment in adults with moderate to severe atopic dermatitis (eczema)
    Ensayo fase 2 para evaluar la eficacia y seguridad de los comprimidos de LEO 152020 administrados por vía oral en comparación con los comprimidos de placebo durante un período de hasta 16 semanas de tratamiento en adultos con dermatitis atópica de moderada a grave (eczema)
    A.4.1Sponsor's protocol code numberLP0190-1488
    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 Regulatory Affairs
    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.5.6E-mailraleodk@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 152020 film-coated tablet (50 mg)
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNnot applicable at this stage
    D.3.9.1CAS number 1429375-85-8
    D.3.9.2Current sponsor codeLEO 152020B
    D.3.9.3Other descriptive nameLEO 152020 sulfate monohydrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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
    Atopic Dermatitis (AD)
    Dermatitis atópica (DA)
    E.1.1.1Medical condition in easily understood language
    Eczema
    Eczema
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    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
    To explore the exposure response relationship of LEO 152020 and evaluate efficacy of LEO 152020 compared with placebo for up to 16 weeks of treatment in subjects with moderate to severe atopic dermatitis
    Explorar la relación exposición-respuesta a LEO 152020 y evaluar la eficacia de LEO 152020 en comparación con placebo durante un máximo de 16 semanas de tratamiento en pacientes con dermatitis atópica de moderada a grave
    E.2.2Secondary objectives of the trial
    To evaluate the safety of LEO 152020 compared with placebo in subjects with moderate to severe atopic dermatitis
    Evaluar la seguridad de LEO 152020 en comparación con placebo en pacientes con dermatitis atópica de moderada a grave.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Adult, age 18 years or older at baseline.
    •Diagnosis of chronic atopic dermatitis (AD).
    •History of AD ≥1 year prior to baseline.
    •Recent (within 6 months prior to baseline) documented history of inadequate response to topical AD treatments or subject for whom topical AD treatments are medically inadvisable.
    •7.1≤ EASI ≤50 at baseline
    •vIGA AD score ≥3 at baseline.
    •Adulto, mayor de 18 años en la visita basal.
    •Diagnóstico de dermatitis atópica (DA) crónica.
    •Antecedentes de DA ≥1 año antes de la visita basal.
    •Antecedentes documentados recientes (en los 6 meses anteriores a la visita basal del ensayo) de respuesta insuficiente a los tratamientos tópicos para la DA o pacientes para quienes los tratamientos tópicos para la DA sean médicamente desaconsejables.
    •7,1 ≤ EASI ≤50 en la visita basal.
    •Puntuación vIGA-AD ≥3 en la visita basal.
    E.4Principal exclusion criteria
    •Previous treatment with an oral H4R antagonist (including LEO 152020) within 6 months prior to baseline.
    •Previous treatment with 3 or more systemic AD treatments prior to screening.
    •Women who are pregnant or lactating.
    •Tratamiento previo con un antagonista de H4R oral (incluido LEO 152020) en los 6 meses previos a la visita basal.
    •Tratamiento previo con 3 o más tratamientos sistémicos para la DA antes de la selección.
    •Mujeres embarazadas o en período de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint
    •Change in EASI from baseline to Week 16.
    Criterio de valoración primario
    •Cambio en el EASI desde la visita basal hasta la semana 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Semana 16
    E.5.2Secondary end point(s)
    Secondary endpoint
    •Number of AEs from baseline to Week 16+3 days per subject.
    Criterio de valoración secundario
    •Número de AA desde la visita basal hasta la semana 16+3 días por paciente.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16 + 3 days

    Please refer to E.5.2 where the timepoint is specified beside each exploratory end point.
    Semana 16 + 3 días

    Por favor veáse el apartado E.5.2 dónde se especifica el momento de cada criterio de valoración exploratorio.
    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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    Triple ciego
    Triple Blind
    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 trial4
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Japan
    United States
    France
    Germany
    Poland
    Spain
    Czechia
    E.8.7Trial has a data monitoring committee Yes
    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 visit of the last subject - LSLV
    Última visita último paciente - LSLV
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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: 214
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 129
    F.4.2.2In the whole clinical trial 224
    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)
    Participants return to there standard of care in their respective country.
    Los pacientes volverán al tratamiento según la práctica clínica habitual de cada país.
    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 Decision2021-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-28
    P. End of Trial
    P.End of Trial StatusOngoing
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