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    Summary
    EudraCT Number:2019-003801-90
    Sponsor's Protocol Code Number:EFC16460
    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:2020-05-07
    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 number2019-003801-90
    A.3Full title of the trial
    A randomized, double blind, placebo-controlled, multi-center, parallel group study to evaluate the efficacy and safety of dupilumab in patients with prurigo nodularis who are inadequately controlled on topical prescription therapies or when those therapies are not advisable
    Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, de grupos paralelos para evaluar la eficacia y seguridad de dupilumab en pacientes con prurigo nodular que no están adecuadamente controlados con terapias tópicas de prescripción o cuando dichas terapias no son recomendables
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of dupilumab for the treatment of patients with prurigo nodularis, inadequately controlled on topical prescription therapies or when those therapies are not advisable
    Estudio de dupilumab para el tratamiento de pacientes con prurigo nodular que no están controlados adecuadamente con tratamientos tópicos de prescripción o cuando dichas terapias no son recomendables
    A.3.2Name or abbreviated title of the trial where available
    LIBERTY-PN PRIME2
    LIBERTY-PN PRIME2
    A.4.1Sponsor's protocol code numberEFC16460
    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 SponsorSanofi-aventis Recherche & Développement
    B.1.3.4CountryFrance
    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 supportSanofi-aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a.
    B.5.2Functional name of contact pointUnidad de Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla 2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number3493485 94 00
    B.5.6E-mailes-unidadestudiosclinicos@sanofi.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 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.3.9.2Current sponsor codeSAR231893
    D.3.9.3Other descriptive nameREGN668
    D.3.9.4EV Substance CodeSUB88511
    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) No
    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
    Prurigo Nodularis
    Prurigo nodular
    E.1.1.1Medical condition in easily understood language
    Prurigo Nodularis
    Prurigo nodular
    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 PT
    E.1.2Classification code 10029263
    E.1.2Term Neurodermatitis
    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
    To demonstrate the efficacy of dupilumab on itch response in patients with prurigo nodularis (PN), inadequately controlled on topical prescription therapy or when those therapies are not advisable
    Demostrar la eficacia de dupilumab en la respuesta al prurito en pacientes con PN que no están controlados adecuadamente con tratamientos tópicos de prescripción o cuando estas terapias no son aconsejables.
    E.2.2Secondary objectives of the trial
    To demonstrate the efficacy of dupilumab on additional itch endpoints in patients with PN, inadequately controlled on topical prescription therapy or when those therapies are not advisable
    To demonstrate efficacy of dupilumab on skin lesions of PN
    To demonstrate the improvement in health-related quality of life
    To evaluate safety outcome measures
    To evaluate immunogenicity of dupilumab
    Demostrar la eficacia de dupilumab en cuanto a los criterios de valoración adicionales de prurito en pacientes con PN que no están controlados adecuadamente con tratamientos tópicos de prescripción o cuando estas terapias no son aconsejables.
    Demostrar la eficacia de dupilumab en lesiones cutáneas de PN.
    Demostrar la mejoría en la calidad de vida relacionada con la salud (CVRS).
    Evaluar las medidas de los resultados de seguridad.
    Evaluar la inmunogenicidad de dupilumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Must be 18 to 80 years of age, at the time of signing the informed consent.
    With a clinical diagnosis of PN defined by all of the following:
    - Diagnosed by a dermatologist for at least 3 months before the Screening visit
    - On the WI-NRS ranging from 0 to 10, patients must have an average worst itch score of ≥7 in the 7 days prior to Day1.
    - Patients must have a minimum of 20 PN lesions in total on both legs, and/or both arms and/or trunk, at Screening visit and Day 1
    - History of failing a 2-week course of medium-to-high potency topical corticosteroids (TCS) or when TCS are not medically advisable
    - Have applied a stable dose of topical emollient (mositurizer) once or twice daily for at least the 7 consecutive days immediately before Day 1
    Must be willing and able to complete a daily symptom eDiary for the duration of the study
    Los participantes deben tener entre 18 y 80 años en el momento de firmar el consentimiento informado.
    Pacientes con diagnóstico clínico de Prurigo nodular (PN), según lo definido a continuación:
    - Diagnosticado por un dermatólogo por lo menos 3 meses antes de la visita de selección
    - En la Escala Numérica de Clasificación del Peor Picor (ENC-PP) que va de 0 a 10, los pacientes deben tener una puntuación media de peor picazón ≥ 7 en los 7 días anteriores al día 1.
    - Los pacientes deben tener un mínimo de 20 lesiones de PN en total en ambas piernas y/o ambos brazos y/o tronco, en la visita de selección y el día 1.
    - Antecedentes de fracaso de un curso de 2 semanas de corticoesteroides tópicos (CET) de potencia media a alta o cuando el CET no es médicamente aconsejable
    - Aplicación de una dosis estable de emoliente tópico (loción hidratante) una o dos veces al día durante al menos los 7 días inmediatamente anteriores al día 1
    Los participantes deben estar dispuestos y ser capaces de rellenar un diario electrónico de síntomas diarios durante el estudio.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    - Presence of skin morbidities other than PN and mild atopic dermatitis that may interfere with the assessment of the study outcomes
    - PN secondary to medications
    - PN secondary to medical conditions such as neuropathy or psychiatric disease
    - A documented atopic dermatitis severity of moderate to severe within 6 months before or at the Screening visit
    - Severe concomitant illness(es) under poor control that, in the investigator’s judgment, would adversely affect the patient’s participation in the study
    - Severe renal conditions (eg, patients with uremia and/or on dialysis)
    - Participants with uncontrolled thyroid disease.
    - Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated
    - 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.
    - Active chronic or acute infection (except HIV) requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit
    - Known or suspected immunodeficiency
    -Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
    Se excluirá del estudio a los participantes que cumplan alguno de los siguientes criterios:
    - Presencia de morbilidades cutáneas distintas del PN y la DA leve que pueden interferir en la evaluación de los resultados del estudio.
    - PN secundario a medicamentos
    - PN secundaria a afecciones médicas como neuropatía o enfermedad psiquiátrica
    - Pacientes con una gravedad documentada de DA moderada a intensa en los 6 meses anteriores o en la visita de selección
    - Enfermedad(es) concomitante(s) grave(s) mal controladas que, a criterio del investigador, pudiera(n) afectar negativamente la participación del paciente en el estudio
    - Afecciones renales graves (p. ej., pacientes con uremia y/o diálisis)
    - Participantes con enfermedad tiroidea no controlada
    - Los pacientes con tuberculosis (TB) activa, infección micobacteriana no tuberculosa o antecedentes de TB tratada de forma incompleta serán excluidos del estudio a menos que esté bien documentado por un especialista que el paciente ha sido tratado adecuadamente
    - Diagnóstico de infección endoparasitaria activa; riesgo alto o sospecha de infección endoparasitaria, salvo que las evaluaciones clínicas y de laboratorio (si es necesario) hayan descartado una infección activa antes de la aleatorización
    - Infección crónica o aguda activa (excepto VIH) que requiera tratamiento con antibióticos sistémicos, antivirales, antiprotozoarios o antifúngicos en las 2 semanas anteriores a la visita de selección
    - Informe o sospecha de inmunodeficiencia
    - Neoplasia maligna activa o antecedentes de neoplasia maligna en los 5 años previos a la visita de selección, excepto carcinoma del cuello uterino in situ completamente tratado, carcinoma de células basales o de células escamosas no metastásico en la piel completamente tratado y resuelto.
    E.5 End points
    E.5.1Primary end point(s)
    Improvement (reduction) in worst-itch numeric rating scale (WI-NRS) by ≥ 4 , Proportion of participants with improvement (reduction) in worst-itch numeric rating scale (WI-NRS) by ≥4 from baseline to Week 12
    Proporción de participantes con una mejora (reducción) ≥4 en la Escala Numérica de Clasificación del Peor Picor (ENC-PP) desde el inicio hasta la semana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 12
    Desde el inicio hasta la semana 12.
    E.5.2Secondary end point(s)
    1 - Improvement (reduction) in worst-itch numeric rating scale (WI-NRS) by ≥ 4 ; Proportion of participants with improvement (reduction) in worst-itch numeric rating scale (WI-NRS) by ≥4 from baseline to Week 24
    2 - Time to onset of effect on pruritus ; Time to onset of effect on pruritus as measured by proportion of participants with an improvement (reduction) in WI-NRS by ≥4 from baseline during the 24-week treatment period
    3 - Change from baseline in WI-NRS ; Change from baseline in WI-NRS at Week 12 and Week 24
    4 - Percent change from baseline in WI-NRS ; Percent change from baseline in WI-NRS at Week 12 and Week 24
    5 - Percent change from baseline in WI-NRS over time ; Percent change from baseline in WI-NRS over time until Week 24
    6 - Proportion of participants with WI-NRS reduction ≥ 4 over time ; Proportion of participants with WI-NRS reduction ≥ 4 over time until Week 24
    7 - Onset of action in change from baseline in WI-NRS ; Onset of action in change from baseline in WI-NRS (first p<0.05 difference from placebo in the daily WI-NRS that remains significant at subsequent measurements) until Week 12
    8 - Proportion of participants with Investigator’s Global Assessment 0/1 score for PN-stage ; Proportion of participants with Investigator’s Global Assessment 0/1 score for PN-Stage (IGA PN-S) at Week 4, Week 8, Week 12, and Week 24.
    9 - Change from baseline in IGA PN-S score ; Change from baseline in IGA PN-S score at Week 4, Week 8, Week 12 and Week 24
    10 - Proportion of participants with Investigator’s Global Assessment 0/1 score for PN-Assess ; Proportion of participants with Investigator’s Global Assessment 0/1 score for PN-Assess (IGA PN-A) at Week 4, Week8, Week 12, and Week 24
    11 - Change from baseline in health-related quality-of-life ; Change from baseline in health-related quality-of-life, as measured by Dermatology Life Quality Index (DLQI) to Week 12 and Week 24
    12 - Adverse Events ; Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) from baseline through Week 24
    13 - Immunogenicity ; Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab over time
    1 - Proporción de participantes con mejora (reducción) ≥4 en la Escala Numérica de Clasificación del Peor Picor (ENC-PP) desde el inicio hasta la semana 24.
    2. Tiempo hasta el inicio del efecto en el prurito; Tiempo hasta el inicio del efecto en el prurito medido por la proporción de participantes con una mejora (reducción) ≥4 en la ENC-PP desde el inicio durante el período de tratamiento de 24 semanas.
    3 - Cambio desde el inicio en la ENC-PP en las semanas 12 y 24.
    4 - Cambio porcentual desde el inicio en la ENC-PP en las semanas 12 y 24
    5 - Cambio porcentual desde el inicio en la ENC-PP hasta la semana 24.
    6 - Proporción de participantes con reducción ≥4 en la ENC-PP hasta la semana 24
    7 - Inicio de la acción del cambio desde el inicio en la ENC-PP (primera diferencia p < 0,05 respecto al placebo en la ENC-PP diaria que sigue siendo significativa en las mediciones posteriores) hasta la semana 12.
    8 - Proporción de participantes con una puntuación de 0/1 en la escala de evaluación Global del Investigador para la Valoración del PN (EGI-ePN) en las semanas 4, 8, 12 y 24
    9 - Cambio desde el inicio en la puntuación de la EGI-ePN en las semanas 4, 8, 12 y 24
    10 - Proporción de participantes con una puntuación de 0/1 en la escala de Evaluación Global del Investigador para la Valoración del PN (EGI VPN) en la semana 4, 8, 12 y 24
    11 - Cambio desde el inicio en la CVRS, medido por el índice de calidad de vida en dermatología (ICVD) hasta las semanas 12 y 24
    12 - Porcentaje de participantes que experimentan acontecimientos adversos derivados del tratamiento (AADT) y acontecimientos adversos graves (AAG) desde el inicio hasta la semana 24
    13 - Incidencia de los anticuerpos antifármaco (AAF) derivados del tratamiento contra dupilumab con el paso del tiempo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 12, 13 : Baseline to Week 24
    2, 5, 6 : Baseline to overtime until Week 24
    3, 4, 11 : Baseline to Week 12 and Week 24
    7 : Baseline to overtime until Week 12
    8, 9, 10 : Baseline to Week 4, Week 8, Week 12, and Week 24
    1, 12, 13 : desde el inicio hasta la semana 24
    2, 5, 6 : desde el inicio con el paso del tiempo hasta la semana 24
    3, 4, 11 : desde el inicio hasta la semana 12 y semana 24
    7 : desde el inicio con el paso del tiempo hasta la semana 12
    8, 9, 10: desde el inicio hasta la semana 4, semana 8, semana 12, y semana 24
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Chile
    France
    Hungary
    Italy
    Portugal
    Spain
    Taiwan
    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
    Última visita del último paciente
    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 months7
    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 months7
    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: 102
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 73
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 111
    F.4.2.2In the whole clinical trial 175
    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
    Ninguno
    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 Decision2020-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-31
    P. End of Trial
    P.End of Trial StatusOngoing
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