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    The EU Clinical Trials Register currently displays   42517   clinical trials with a EudraCT protocol, of which   7000   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-001198-15
    Sponsor's Protocol Code Number:R668-AD-1334
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-12-04
    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 number2014-001198-15
    A.3Full title of the trial
    A PHASE 3 CONFIRMATORY STUDY INVESTIGATING THE EFFICACY AND SAFETY OF DUPILUMAB MONOTHERAPY ADMINISTERED TO ADULT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
    ESTUDIO CONFIRMATORIO DE FASE 3 PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE LA MONOTERAPIA CON DUPILUMAB EN PACIENTES ADULTOS CON DERMATITIS ATÓPICA DE GRADO MODERADO A SEVERO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to confirm the efficacy and safety of dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD)
    Estudio para confirmar la seguridad y la eficacia de dupilumab en monoterapia en adultos con dermatitis atópica de grado moderado a severo.
    A.3.2Name or abbreviated title of the trial where available
    Liberty AD Solo
    A.4.1Sponsor's protocol code numberR668-AD-1334
    A.5.4Other Identifiers
    Name:Investigational New DrugNumber:IND 107969
    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 SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trials information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post codeNY 10591
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34 916006186
    B.5.6E-mailclinicaltrial@regeneron.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 nameDupilumab
    D.3.2Product code REGN668/SAR231893
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDupilumab
    D.3.9.1CAS number 1190264-60-8
    D.3.9.2Current sponsor codeREGN668/SAR231893
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atopic dermatits
    Dermatitis Atópica.
    E.1.1.1Medical condition in easily understood language
    Atopic dermatitis / Eczema
    Eczema / Dermatitis Atópica
    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 17.1
    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
    The primary objective of the study is to demonstrate the efficacy of dupilumab monotherapy compared to placebo treatment in adult patients with moderate-to-severe AD.
    El objetivo principal es demostrar la eficacia de dupilumab en monoterapia en comparación con el tratamiento con un placebo en pacientes adultos con dermatitis atópica (DA) de moderada a grave.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to assess the safety of dupilumab monotherapy compared to placebo treatment in patients with moderate-to-severe AD.
    El objetivo secundario del estudio es evaluar la seguridad de dupilumab en monoterapia en comparación con el tratamiento con un placebo en pacientes adultos con DA de moderada a grave.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional genomics sub-study. Blood for DNA sample should be collected on day 1 or at any visit during the study. Blood for RNA sample must be collected before the administration of the first dose of study drug.
    Subestudio genómico opcional. La muestra de sangre para la extracción del ADN debe ser recogida en el día 1/momento basal, aunque puede obtenerse también en cualquiera de las visitas del estudio. La sangre para la muestra de ARN debe ser recogida antes de la administración de la primera dosis del fármaco del estudio.
    E.3Principal inclusion criteria
    A patient must meet the following criteria to be eligible for inclusion in the study:
    1. Male or female, 18 years or older
    2. Chronic AD, (according to American Academy of Dermatology Consensus Criteria [Eichenfield 2014]), that has been present for at least 3 years before the screening visit
    3. EASI score ?16 at the screening and baseline visits
    4. IGA score ?3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at the screening and baseline visits
    5. ?10% body surface area (BSA) of AD involvement at the screening and baseline visits
    6. Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks
    7. Have applied a stable dose of topical emollient (moisturizer) twice daily for at least 7 days before the baseline visit (NOTE: See exclusion criterion #6 for limitations regarding emollients)

    Inclusion criteria 8-10 (see protocol section 4.2)
    Un paciente debe cumplir los siguientes criterios para ser considerado elegible para la inclusión en el estudio:
    1.Varón o mujer, de edad igual o superior a 18 años.
    2.DA crónica (según los Criterios del Consenso de la American Academy of Dermatology [Eichenfield 2014]), que haya estado presente durante al menos 3 años antes de la visita de selección.
    3.Una puntuación del EASI >= 16 en la visita de selección y la visita basal.
    4.Una puntuación de la IGA >= 3 (en la escala de IGA de 0 a 4, en la que el valor de 3 corresponde a moderada y el de 4 a grave) en la visita de selección inicial y en la visita basal.
    5.>= 10% de área de superficie corporal (ASC) afectada por la DA en la visita de selección y en la visita basal.
    6.Antecedentes recientes (en los 6 meses previos a la visita de selección) documentados de respuesta insuficiente al tratamiento con medicación tópica, o indicativos de que los tratamientos tópicos son desaconsejables médicamente por otros motivos (por ejemplo, a causa de efectos secundarios importantes o riesgos para la seguridad).
    7.Han aplicado una dosis estable de tratamiento tópico emoliente (humidificante) dos veces al día durante al menos 7 días antes de la visita basal (NOTA: Véase en el criterio de exclusión número 6 las limitaciones relativas a los emolientes)

    Criterios de Inclusion del 8-10 refieranse a la sección 4.2 del protocolo.
    E.4Principal exclusion criteria
    A patient who meets any of the following criteria will be excluded from the study:
    1. Participation in a prior dupilumab clinical study
    2. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
    3.Phototherapy or treatment with immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit
    4. Treatment with TCS or TCI within 1 week before the baseline visit
    5. Treatment with biologics or live attenuated vaccines within protocol-specified timeframes
    6. Active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit.
    7. Known or suspected history of immunosuppression
    8. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening
    9. Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit
    10. At baseline, presence of any conditions listed as criteria for study drug discontinuation
    11. Presence of skin comorbidities that may interfere with study assessments
    12. History of malignancy within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
    13. Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization

    All the exclusion criteria are listed in Protocol section 4.2
    Se excluirá del estudio a todo paciente que cumpla alguno de los siguientes criterios:
    1.Participación en un estudio clínico previo de dupilumab
    2.Tratamiento con un fármaco en fase de investigación en un plazo de 8 semanas o en un plazo de 5 periodos de semivida (en el caso de que esta se conozca), optando de entre ambos por el más prolongado, antes de la visita basal.
    3.Haber utilizado fototerapia o tratamiento con inmunosupresores/inmunomoduladores en un plazo de 4 semanas antes de la visita basal.
    4.Tratamiento con CST o ICT en el plazo de 1 semana antes de la visita basal.
    5. Tratamientos con vacunas atenuadas vivas o biológicos dentro de los periodos de tiempo especificados en el protocolo.
    6. Infección crónica o aguda activa que requiera tratamiento sistémico con antibióticos, antivirales, antiparasitarios, antiprotozoarios o antifúngicos en un plazo de 2 semanas antes de la visita del momento basal.
    7. Antecedentes conocidos o sospechados de inmunodepresión.
    8.Antecedentes de infección por el virus de la inmunodeficiencia humana (VIH) o serología de VIH positiva en la selección.
    9.Positividad para el antígeno de superficie de la hepatitis B (AgHBs) o para anticuerpos contra el virus de la hepatitis C en la visita de selección.
    10.En el momento basal, presencia de cualquier trastorno enumerado en los criterios para la interrupción del tratamiento con el fármaco del estudio.
    11.Presencia de comorbilidades cutáneas que puedan interferir en las evaluaciones del estudio.
    12.Antecedentes de enfermedad maligna en un plazo de 5 años antes de la visita de selección, excepto si se ha tratado de un carcinoma de cérvix in situ completamente tratado, o un carcinoma cutáneo basocelular o espinocelular no metastásico, completamente tratado y resuelto.
    13.Infecciones endoparasitarias activas diagnosticadas; sospecha o riesgo elevado de infección endoparasitaria, a menos que una evaluación clínica y (en caso necesario) analítica haya descartado la infección activa antes de la aleatorización.

    Todos los criterios de inclusion están listados en la sección 4.2 del Protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    ? Proportion of patients with both IGA 0 to 1 (on a 5-point scale) and a reduction from baseline of ?2 points at week 16
    For the European Medicines Agency (EMA) and EMA Reference Market Countries only, the co primary endpoints are:
    ? Proportion of patients with EASI-75 (?75% improvement from baseline) at week 16
    ? Proportion of patients with both IGA 0 to 1 (on a 5-point scale) and a reduction from baseline of ?2 points at week 16
    ?El porcentaje de pacientes que presentan una IGA de 0 a 1 (en una escala de 5 puntos) y una reducción en la semana 16 de >= 2 puntos respecto al valor inicial
    ? El porcentaje de pacientes con una EASI-75 (>= 75% de mejoría respecto al valor inicial) en la semana 16
    ?El porcentaje de pacientes que presentan tanto una IGA de 0 a 1 (en una escala de 5 puntos) y una reducción en la semana 16 de >= 2 puntos respecto al valor inicial
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be determined at week 16.
    El criterio de valoración principal será determinado en la semana 16.
    E.5.2Secondary end point(s)
    ? Proportion of patients with EASI-75 (?75% improvement from baseline) at week 16 (this is not a secondary endpoint for the EMA as it is already a co-primary endpoint)
    ? Percent change from baseline to week 16 in pruritus NRS
    ? Proportion of patients with improvement (reduction) of pruritus NRS ?3 from baseline to week 16
    ? Percent change in EASI score from baseline to week 16
    ? Change from baseline to week 16 in percent BSA
    ? Change from baseline to week 16 in SCORAD
    ? Change from baseline to week 16 in GISS (erythema, infiltration/papulation, excoriations, lichenification)
    ? Change from baseline to week 16 in DLQI
    ? Change from baseline to week 16 in HADS
    ? Change from baseline to week 16 in POEM
    ? Percent change from baseline to week 2 in pruritus NRS
    ? Incidence of skin infection treatment-emergent adverse events (TEAE) requiring systemic treatment from baseline through week 16
    ? Incidence of treatment-emergent serious adverse events (TESAEs) from baseline through week 16
    ? Incidence of TEAEs leading to treatment discontinuation from baseline through week 16
    ? Overall incidence of TEAEs through week 16
    ?El porcentaje de pacientes con una EASI-75 (>= 75% de mejoría respecto al valor inicial) en la semana 16 (esto no constituye un criterio de valoración secundario para la EMA puesto que es ya uno de los criterios de valoración principales)
    ?El cambio porcentual en la semana 16 respecto al valor inicial en la escala numérica para la evaluación del prurito
    ?El porcentaje de pacientes con una mejoría (reducción) en la NRS del prurito de la semana 16 de >= 3 respecto al valor inicial
    ?El cambio porcentual de la puntuación EASI de la semana 16 respecto al valor inicial
    ?El cambio en la semana 16 respecto al valor basal en el porcentaje de área de superficie corporal (ASC)
    ?El cambio en la semana 16 respecto al valor basal en la puntuación SCORing Atopic Dermatitis (SCORAD)
    ?El cambio en la semana 16 respecto al valor basal en la puntuación Global Individual Signs Score (GISS) (eritema, infiltración / población, excoriaciones, liquenificación).
    ?El cambio en la semana 16 respecto al valor basal en el Dermatology Life Quality Index (DLQI)
    ?El cambio en la semana 16 respecto al valor basal en la Hospital Anxiety Depression Scale (HADS)
    ?El cambio en la semana 16 respecto al valor basal en la Patient Oriented Eczema Measure (POEM)
    ?El cambio porcentual en la NRS del prurito de la semana 2 respecto al valor inicial
    ?La incidencia de acontecimientos adversos surgidos con el tratamiento (AAST) consistentes en infecciones cutáneas que requieren un tratamiento sistémico desde el momento basal hasta la semana 16
    ?La incidencia de acontecimientos adversos graves surgidos con el tratamiento (AAGST) desde el momento basal hasta la semana 16
    ?La incidencia de AAST que conducen a una interrupción definitiva del tratamiento desde el momento inicial hasta la semana 16
    ?La incidencia global de AAST hasta la semana 16
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be determined from baseline to week 16.
    Los criterios de valoración secundarios se determinaran desde la visita basal hasta la semana 16.
    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 Yes
    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) 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 No
    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 trial3
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Bulgaria
    Canada
    Denmark
    Estonia
    Finland
    Germany
    Japan
    Singapore
    Spain
    United States
    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 patient last visit in follow up phase (week 28)
    Último paciente última visita de las fase de seguimiento (semana 28)
    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 months4
    E.8.9.1In the Member State concerned days0
    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 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: 550
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 600
    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)
    1. Patients with IGA 0 to 1 or eczema area severity index (EASI)-75 at week 16 not received rescue treatment for AD will be eligible to participate in a maintenance study (4 treatment arms): a) 300 mg qw or 300 mg q2w, b) 300 mg q4w, c) 300 mg q8w, d) Placebo, or may be eligible to participate in an open label extension (OLE) study (treatment with dupilumab), no sooner than 36 weeks after completing the week 16.
    2. Patients with IGA 3 to 4 may be eligible to enroll in a OLE study at week 20.
    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 Decision2015-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-12
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