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    EudraCT Number:2021-002967-23
    Sponsor's Protocol Code Number:M-17923-30
    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:2021-08-31
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2021-002967-23
    A.3Full title of the trial
    A Randomised, Double-Blind, Placebo-Controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adult and Adolescent Patients With Moderate-To-Severe Atopic Dermatitis That Are Not Adequately Controlled With Cyclosporine or For Whom Cyclosporine is Not Medically Advisable.
    Un ensayo clínico de fase 3 aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y seguridad de lebrikizumab en combinación con corticoides tópicos en pacientes adultos y adolescentes con dermatitis atópica de moderada a grave que no se controlan adecuadamente con ciclosporina o para quienes la ciclosporina no es médicamente aconsejable.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of lebrikizumab in patients with AD not adequately controlled or non-eligible for cyclosporine
    Eficacia y seguridad de lebrikizumab en pacientes con dermatitis atópica
    (DA) no adecuadamente controlada o no elegibles para ciclosporina.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberM-17923-30
    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 SponsorAlmirall, S.A.
    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 supportAlmirall, S.A.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlmirall, S.A.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressRonda General Mitre, 151
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08022
    B.5.4Telephone number+34932913545
    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 nameLebrikizumab
    D.3.2Product code LY3650150
    D.3.4Pharmaceutical form Solution for injection
    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 INNlebrikizumab
    D.3.9.2Current sponsor codeLY3650150
    D.3.9.3Other descriptive nameLEBRIKIZUMAB
    D.3.9.4EV Substance CodeSUB31913
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 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 dermatitis
    Dermatitis atópica
    E.1.1.1Medical condition in easily understood language
    atopic dermatitis
    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 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 evaluate the efficacy of lebrikizumab compared with placebo in patients not adequately controlled with cyclosporine or for
    whom cyclosporine is not medically advisable up to Week 16
    Evaluar la eficacia de lebrikizumab en comparación con placebo en pacientes no controlados adecuadamente con ciclosporina o para los que la ciclosporina no es médicamente aconsejable hasta la semana 16.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy in patients not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable
    between Week 16 up to Week 52.
    Evaluar la eficacia en pacientes que no se controlan adecuadamente con ciclosporina o en los que la ciclosporina no es médicamente aconsejable entre la semana 16 y la 52.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults and adolescents (aged ≥12 to <18 years at the time of ICF/IAF and weighing ≥40kg)
    2. Chronic AD (according to Hanifin and Rajka Criteria 2) that has been present for ≥1 year before the Screening visit
    3. EASI score ≥16 at the Baseline Visit
    4. IGA score ≥3 (moderate) (scale of 0 [clear] to 4 [severe]) at the Baseline visit
    5. ≥10% BSA of AD involvement at the Baseline visit
    6. Documented history by a physician of an inadequate response to existing topical medications within 6 months before Screening, defined as: inability to achieve good disease control (eg, not able to achieve IGA ≤2) after use of at least a moderate-potency TCS for
    at least 4 weeks, or for the maximum duration recommended by the product prescribing information (eg, 14 days for ultra-high-potency TCS), whichever is shorter
    7. Documented history by a physician of either:
    a) No previous CsA exposure and not currently a candidate for CsA treatment because of
    i. medical contraindications (eg, uncontrolled hypertension on medication), or
    ii. use of prohibited concomitant medications (eg, statins, digoxin, macrolide antibiotics, barbiturates, anti-seizure drugs, nonsteroidal anti-inflammatory drugs, diuretics, angiotensin-converting-enzyme inhibitors, St John’s Wort, etc.), or
    iii. increased susceptibility to CsA-induced renal damage (elevated creatinine) and/or liver damage (elevated function tests results), or
    iv. increased risk of serious infections, or
    v. hypersensitivity to CsA active substance or excipients
    b) Previous exposure to CsA; CsA treatment should not be continued or restarted because of:
    i. intolerance and/or unacceptable toxicity (eg, elevated creatinine, elevated liver function test results, uncontrolled hypertension, paraesthesia, headache, nausea, hypertrichosis); or
    ii. requirement for CsA at doses or durations beyond those specified in the prescribing information or inadequate response
    8. Completed electronic diary (eDiary) entries for pruritus and sleep-loss for a minimum of 4 of 7 days before randomisation
    9. Willing and able to comply with all clinic visits and study-related procedures and questionnaires
    10. For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or to use a highly effective contraceptive method during the treatment period and for at least 18 weeks after the last dose of lebrikizumab or placebo
    11. Male patients must agree to use an effective barrier method of contraception during the study and for a minimum of 18 weeks following the last dose of study drug if sexually active with a WOCBP
    12. Patient must provide signed ICF. Adolescent patients must also provide separate informed assent to enrol in the study and sign and date either a separate IAF or the ICF signed by the parent/legal guardian (as appropriate based on local regulations and requirements).
    1. Adultos y adolescentes (de ≥12 a <18 años de edad al momento de firmar el formulario de consentimiento informado (FCI)/formulario de asentimiento informado (FAI) con un peso de ≥40 kg)
    2. Dermatitis atópica (DA) crónica (según los criterios de Hanifin y Rajka) presente durante ≥1 año antes de la visita de selección
    3. Puntuación del Índice de gravedad y área del eczema (Eczema Area and Severity Index, EASI) de ≥16 en la visita inicial
    4. Puntuación de la Evaluación global del investigador (Investigator Global Assessment, IGA) de ≥3 (moderada) (escala de 0 [aclaramiento] a 4 [grave]) en la visita inicial
    5. ≥10 % del área de superficie corporal (ASC) afectada por la DA en la visita inicial
    6. Antecedentes documentados por un médico de una respuesta inadecuada a medicamentos tópicos existentes en los 6 meses previos a la selección, lo que se define como: incapacidad de lograr un buen control de la enfermedad (p. ej., no puede lograr una puntuación de IGA de ≤2) después de usar al menos un corticoesteroide tópico (TCS) de potencia moderada, aplicado durante al menos 4 semanas o la duración máxima según la información de prescripción (p. ej., 14 días para un TCS de potencia muy alta), el período que sea más breve
    7. Antecedentes documentados por un médico de alguno de los siguientes factores:
    a) No tuvo una exposición previa a la ciclosporina A (CsA) y no es candidato actualmente para el tratamiento con CsA debido a lo siguiente:
    i. contraindicaciones médicas (p. ej., hipertensión no controlada con medicamentos); o
    ii. uso de medicamentos concomitantes prohibidos (p. ej., estatinas, digoxina, antibióticos macrólidos, barbitúricos, fármacos anticonvulsivos, fármacos antiinflamatorios no esteroideos, diuréticos, inhibidores de la enzima convertidora de la angiotensina, hipérico, etc.); o
    iii. mayor susceptibilidad al daño renal inducido por CsA (creatinina elevada) o afectación del hígado (resultados elevados de pruebas de función hepática); o
    iv. mayor riesgo de infecciones graves; o
    v. hipersensibilidad al principio activo o a los excipientes de la CsA
    b) Exposición previa a la CsA; el tratamiento con CsA no debería continuarse o reiniciarse debido a lo siguiente:
    i. intolerancia o toxicidad inaceptable (p. ej., creatinina elevada, resultados de prueba de función hepática elevada, hipertensión no controlada, parestesia, dolor de cabeza, náuseas, hipertricosis); o
    ii. necesidad de CsA en dosis o duraciones más altas que aquellas especificadas en la información de prescripción, o respuesta inadecuada
    8. Diario electrónico completo sobre prurito y pérdida del sueño durante un mínimo de 4 a 7 días antes de la aleatorización
    9. Disposición para acudir a todas las visitas y realizar los procedimientos y cuestionarios del estudio
    10. Las mujeres en edad fértil deben practicar la abstinencia (evitar las relaciones sexuales heterosexuales) o emplear un método anticonceptivo de alta eficacia durante el tratamiento y, al menos, durante las 18 semanas siguientes tras recibir la última dosis de lebrikizumab o placebo
    11. Los pacientes masculinos deben aceptar el uso de un método anticonceptivo de barrera efectivo durante el estudio y, al menos, durante las 18 semanas siguientes tras recibir la última dosis del fármaco del estudio si son sexualmente activos con una mujer en edad fértil (MEF)
    12. El paciente debe proporcionar un FCI firmado. Los pacientes adolescentes también deben proporcionar un asentimiento informado aparte para inscribirse en el estudio y, además de firmar y fechar un FAI aparte o el FCI firmado por el padre, la madre o el tutor legal (según corresponda en virtud de los reglamentos y requisitos).
    E.4Principal exclusion criteria
    1. Participation in a prior lebrikizumab clinical study
    2. Treatment with IL-4 or IL-13 antagonists biological therapies before the Baseline visit.
    Exception: previous treatment with dupilumab will be allowed in a subset of patients. A wash-out of at least 8 weeks before the Baseline visit will be required for this subpopulation
    3. Treatment with TCS within 1 week before the Baseline visit
    4. Treatment with topical calcineurin inhibitors, phosphodiesterase-4 inhibitors such as crisaborole, or cannabinoids within 2 week before the Baseline visit
    5. Treatment with any of the following agents within 4 weeks before the Baseline visit:
    a. Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon-γ, JAK inhibitors, azathioprine, methotrexate, etc.)
    b. Phototherapy and photochemotherapy (PUVA) for AD
    6. Treatment with the following before the Baseline visit:
    a. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer;
    b. B cell-depleting biologics, including but not limited to rituximab, within 6 months;
    c. Other biologics within 16 weeks or 5 half-lives (if known) , whichever is longer
    7. Treatment with a live (attenuated) vaccine within 12 weeks of the Baseline visit, planned during the study, or 12 weeks after the study treatment is discontinued
    8. History of anaphylaxis as defined by the Sampson criteria 40
    9. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the Screening visit
    10. Uncontrolled chronic disease that might require bursts of oral corticosteroids, eg, comorbid severe uncontrolled asthma (defined by an Asthma Control Questionnaire-5 score ≥1.5 or a history of ≥2 asthma exacerbations within the last 12 months requiring systemic [oral and/or parenteral] corticosteroid treatment or hospitalisation for >24 hours)
    11. Have had any of the following types of infection within 3 months of Screening or develop any of these infections before randomisation:
    a. Serious (requiring hospitalisation, and/or IV or equivalent oral antibiotic treatment);
    b. Opportunistic (as defined in Winthrop et al. 2015). NOTE: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over;
    c. Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer);
    d. Recurring (including, but not limited to herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis)
    12. Have a current or chronic infection with hepatitis B virus
    13. Have a current infection with hepatitis C virus (ie, positive for hepatitis C RNA)
    14. Have known liver cirrhosis and/or chronic hepatitis of any etiology
    15. Diagnosed active endoparasitic infections or at high risk of these infections
    16. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution: or unusually frequent,
    recurrent, or prolonged infections, per the Investigator’s judgment
    17. History of HIV infection or positive HIV serology at Screening
    18. In the Investigator’s opinion, any clinically significant laboratory test results from the chemistry, haematology, or urinalysis tests obtained at the Screening visit
    19. Presence of skin comorbidities that may interfere with study assessments
    20. History of malignancy, including mycosis fungoides, within 5 years before the Screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks
    21. Severe concomitant illness(es) that in the Investigator’s judgment would adversely affect the patient’s participation in the study. Any other medical or psychological condition that in the opinion of the Investigator may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study patient because of his/her participation in this clinical trial, may make patient’s participation unreliable, or may interfere with study assessments
    22. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
    23. Have had an important side effect to TCS (eg, intolerance to treatment, hypersensitivity reactions, significant skin atrophy, and systemic effects), as assessed by the Investigator or treating physician that would prevent further use.
    1.Participación en 1 estudio clínico previo con lebrikizumab/2.Tratamiento (tto) con terapias biológicas antagonistas de IL-4 o IL-13 antes de la visita inicial.Excepción:se permitirá el tto previo con dupilumab en un subconjunto de pacientes.Se requerirá un reposo farmacológico de al menos 8 semanas antes de la visita inicial para este subgrupo/3.Tto con TCS 1 semana antes de la visita inicial/4.Tto con inhibidores de la calcineurina tópicos,inhibidores de la fosfodiesterasa-4 como crisaborole o cannabinoides en las 2 semanas previas a la visita inicial/5.Tto con alguno de los siguientes medicamentos en las 4 semanas previas a la visita inicial:a.Fármacos inmunodepresores/inmunomoduladores(p.ej.,corticoides sistémicos,ciclosporina,micofenolato de mofetilo,interferón-γ,inhibidores de JAK,azatioprina,metotrexato,etc.);b.Fototerapia y fotoquimioterapia(PUVA) para la DA/6.Tto con alguno de los siguientes medicamentos antes de la visita inicial: a.Un fármaco en fase de investigación en las 8 semanas o 5 semividas(si es conocida) anteriores,el período que sea más extenso;b.Biofármacos citorreductores de células B,incluso rituximab,en los 6 meses previos;c.Otros biofármacos en las 16 semanas o 5 semividas(si es conocida), el período que sea más extenso/7.Tto con una vacuna viva(atenuada) en las 12 semanas previas a la visita inicial, programada durante el estudio,o 12 semanas después de que el tto del estudio sea interrumpido/8.Antecedentes de anafilaxia,tal y como se define en los criterios Sampson 40/9.Uso habitual(más de 2 veces por semana) de cabinas de bronceado en las 4 semanas previas a la visita de selección/10.Enfermedad crónica no controlada que puede requerir la administración de corticoesteroides orales,p.ej.,asma grave concurrente no controlado concomitante(definido por una puntuación del Cuestionario para el control del asma-5 de ≥1,5 o antecedentes de ≥2 exacerbaciones del asma en los últimos 12 meses que requirieron tto(oral o parenteral) con corticoides sistémicos u hospitalización durante>24horas)/11.Ha tenido cualquiera de los siguientes tipos de infecciones en los 3 meses anteriores a la selección o ha desarrollado cualquiera de ellas antes de la aleatorización:a.Grave(que requiere hospitalización,o tto por i.v.o tto equivalente con un antibiótico oral);b.Oportunista(según se define en Winthrop et al. 2015).NOTA:La infección por herpes zóster se considera activa y continua hasta que las vesículas se sequen y formen costra;c.Crónica (duración de síntomas,signos o tratamiento de 6 semanas o más);d.Recurrente(incluso herpes simple,herpes zóster,celulitis recurrente,osteomielitis crónica)/12.Tiene una infección crónica o actual por virus de la hepatitis B/13.Tiene una infección actual por virus de la hepatitisC(p.ej.,resultado positivo de presencia de ARN del virus de la hepatitisC)/14.Tiene cirrosis de hígado o hepatitis crónica conocida de cualquier etiología/15.Endoparasitosis activa diagnosticada o riesgo elevado de contraer estas infecciones/16.Antecedentes o sospecha de antecedentes de inmunodepresión,incluidos antecedentes de infecciones oportunistas invasivas(p.ej.,tuberculosis,histoplasmosis,listeriosis, coccidioidomicosis,neumocistiasis y aspergilosis)a pesar de la curación de la infección;o infecciones prolongadas,recurrentes o anormalmente frecuentes,según el criterio del investigador/17.Antecedentes de infección por VIH o serología positiva para el VIH en la selección/18.Cualquier resultado de prueba de laboratorio de interés clínico obtenido en el análisis bioquímico,de hematología o de orina realizado durante la visita de selección,según el criterio del investigador/19.Presencia de patologías cutáneas que interfieran con los análisis del estudio/20.Antecedentes de neoplasia maligna,incluida micosis fungoides,en los 5 años previos a la visita de selección,excepto el carcinoma de cuello uterino in situ completamente tratado y carcinoma escamocelular o basocelular de piel no metastásico completamente tratado y curado sin evidencia de recurrencia en las últimas 12 semanas/21.Enfermedad(es) concurrente(s)grave(s)que,según el criterio del investigador,afectarían negativamente a la participación del paciente en el estudio.Cualquier otra afección médica o psicológica que,según el criterio del investigador, podría indicar la presencia de una enfermedad nueva o poco conocida,representar un riesgo excesivo para el paciente debido a su participación en este ensayo clínico,reducir la fiabilidad de la participación del paciente o interferir con los análisis del estudio/22.Mujeres embarazadas o en período de lactancia,o que tengan planeado quedar embarazadas o dar el pecho,durante el estudio/23.Haber tenido un efecto secundario importante de los TCS(p.ej.,intolerancia al tto., reacciones de hipersensibilidad, atrofia de la piel significativa y efectos sistémicos),según el criterio del investigador o médico que le trate,que evitaría que se sigan utilizando
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients achieving EASI 75 (≥75% reduction from Baseline in EASI score) at Week 16.
    Porcentaje de pacientes que han alcanzado EASI 75 (p. ej., reducción de ≥75% en EASI) en la semana 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 16
    Semana 16
    E.5.2Secondary end point(s)
    -Percentage of patients achieving IGA 0/1 and 2-point improvement at Week 16.
    -Percentage of patients achieving a 4- point improvement Pruritus NRS at Week 16.
    - % of patients achieving EASI 90 at Week 16.
    - % patients achieving EASI 75, EASI 90 and EASI 50 (by visit up to Week 16)
    - Change from Baseline BSA by visit up to Week 16
    - Change from Baseline SCORAD by visit up to Week 16
    - Change from Baseline Pruritus NRS by visit up to Week 16
    - Change from Baseline sleep loss by
    visit up to Week 16
    - Change from Baseline POEM by visit up to Week 16
    - Change from Baseline DLQI/CDLQI by visit up to Week 16
    - % patients achieving a 4-point improvement DLQI/CDLQI by visit up
    to Week 16
    - Proportion of TCS-free days from Baseline by visit up to Week 16
    -Time to TCS-free use (days) up to Week 16
    - Change from Baseline Skin Pain NRS by visit up to Week 16
    - % patients achieving a 4-point improvement Skin Pain NRS at Week
    - Porcentaje de pacientes que logran una mejora en la puntuación de IGA de 0/1 y 2 puntos en la semana 16
    - Porcentaje de pacientes que logran una mejora en la escala numérica de prurito (Numerical Rating Scale, NRS) de 4 puntos en la semana 16
    - Porcentaje de pacientes con una respuesta de EASI 90 en la semana 16
    - Porcentaje de pacientes con una respuesta de EASI 75, EASI 90 y EASI 50 (por visita hasta la semana 16)
    - Cambios desde el período inicial en la ASC por visita hasta la semana 16
    - Cambios desde el período inicial en el Sistema de puntuación para la dermatitis atópica (SCORing Atopic Dermatitis, SCORAD) por visita hasta la semana 16
    - Cambios desde el período inicial en la NRS de prurito por visita hasta la semana 16
    - Cambios desde el período inicial de pérdida del sueño por visita hasta la semana 16
    - Cambios desde el período inicial de la Medición del eczema orientado al paciente (Patient-Oriented Eczema Measure, POEM) por visita hasta la semana 16
    - Cambios desde el inicio del Índice de calidad de vida dermatológica (Dermatology Life Quality Index, DLQI)/Índice de calidad de vida dermatológica pediátrico (Children’s Dermatology Life Quality Index, CDLQI) por visita hasta la semana 16
    - Porcentaje de pacientes con una mejora de 4 puntos del DLQI/CDLQI por visita hasta la semana 16
    - Proporción de días sin TCS desde el período inicial por visita en la semana 16
    - Tiempo hasta estar libre del uso de TCS (días) hasta la semana 16
    - Cambios desde el período inicial en la NRS de dolor de la piel por visita hasta la semana 16
    - Porcentaje de pacientes que logran una mejora de 4 puntos en la NRS de dolor de piel en la semana 16
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 16
    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 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 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. 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. trial design description
    2 parte del estudio - primera doble-ciego, segunda parte abierto
    2 part of the study - first double-blind, second part open label
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The “end of trial” is defined as the date when all patients randomised in the trial complete
    follow-up contact (either Treatment Completers or those Prematurely Discontinued), or are lost
    to follow-up and have not been able to be contacted, and will be communicated to Competent
    Authorities and the independent ethics committee (IEC) in due time according to local
    El “final del ensayo” se define como la fecha en que todos los pacientes aleatorizados en el ensayo completen el contacto de seguimiento (ya sean los que completaron el tratamiento o aquellos que lo interrumpieron prematuramente), o que se pierden el seguimiento y no han podido ser localizados, y se comunicará a las autoridades competentes y el Comité de Ética Independiente (CEI) a tiempo en virtud de los reglamentos locales.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    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: 39
    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. of subjects for this age range: 39
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 312
    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 state52
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 312
    F.4.2.2In the whole clinical trial 312
    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)
    Once the last dose of study drug is taken (eg, the last visit at which the patient takes IMP [Week
    52]) and related trial measurements are completed, patients should continue to take their usual
    medications, also allowed during the trial, and may resume other medications that were
    interrupted before trial enrolment as deemed appropriate by the Investigator.
    The study drug is for experimental use only, and there are other therapies available to treat the
    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 Decision2021-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-23
    P. End of Trial
    P.End of Trial StatusOngoing
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