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    Summary
    EudraCT Number:2020-003639-41
    Sponsor's Protocol Code Number:UP0089
    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:2022-12-20
    Trial 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 number2020-003639-41
    A.3Full title of the trial
    Phase 1/2A, randomized, placebo-controlled, single-ascending dose (Part A, participant- and investigator-blind) and repeated-dose (Part B, participant-, investigator-, and sponsor-blind) study to investigate the safety, pharmacokinetics, and efficacy of UCB9741 in healthy study participants (Part A) and in study participants with moderate-to-severe atopic dermatitis (Part B)
    Estudio de fase 1/2A, aleatorizado, controlado con placebo, de dosis únicas crecientes (parte A, con enmascaramiento para el participante y el investigador) y de dosis repetidas (parte B, con enmascaramiento para el participante, el investigador y el promotor), para investigar la seguridad, la farmacocinética y la eficacia del UCB9741 en participantes sanos (parte A) y en participantes con dermatitis atópica moderada o severa (parte B)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the safety, pharmacokinetics and efficacy of UCB9741 in healthy study participants and in study participants with atopic dermatitis
    Un estudio para probar la seguridad, la farmacocinética y la eficacia de UCB9741 en participantes sanos y en participantes con dermatitis atópica
    A.4.1Sponsor's protocol code numberUP0089
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04643457
    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 SponsorUCB Biopharma SRL
    B.1.3.4CountryBelgium
    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 supportUCB Biopharma SRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.6E-mailclinicaltrials@ucb.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 nameUCB9741
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUCB9741
    D.3.9.3Other descriptive nameUCB9741
    D.3.9.4EV Substance CodeSUB217372
    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/infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    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
    -Investigation of safety and tolerability of single-ascending doses of UCB9741 administered by intravenous (iv) infusion or subcutaneous (sc) injection to healthy study participants
    -Investigation of safety and tolerability of UCB9741 following repeat-dosing at a single dose level in study participants with with atopic dermatitis (AtD)
    -Investigation of a primary clinical outcome in study participants with AtD after administration of UCB9741 by iv infusion
    - Investigar la seguridad y la tolerabilidad de dosis únicas crecientes de UCB9741, administradas mediante infusión iv o inyección sc a participantes sanos.
    - Investigar la seguridad y la tolerabilidad de UCB9741 después de la administración repetida de un solo nivel de dosis en los participantes con AtD.
    - Investigar el resultado clínico principal en los participantes del estudio con AtD después de la administración de UCB9741 mediante infusión iv.
    E.2.2Secondary objectives of the trial
    -Investigation of pharmacokinetic parameters of UCB9741 administered as single-ascending doses (intravenous and subcutaneous) in healthy study participants
    -Investigation of other clinical outcomes in study participants with AtD after administration of UCB9741 by iv infusion
    -Investigation of pharmacokinetic parameters of UCB9741 following repeat-dosing at a single dose level in study participants with AtD
    - Investigar los parámetros PK de UCB9741 administrado en dosis únicas crecientes (iv y sc) a participantes sanos.
    - Investigar otros resultados clínicos en los participantes con AtD después de la administración de UCB9741 mediante infusión iv.
    - Investigar los parámetros PK de UCB9741 después de la administración repetida de un solo nivel de dosis (6 infusiones iv Q2W (cada 2 semanas) en los participantes con AtD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part A:
    -Participant must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF)
    -Participant must be overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
    -Participant has a body mass index (BMI) within the range 18 to 30 kg/m^2 (inclusive)
    -Participant can be male or female
    −A male participant must agree to use contraception during the Treatment Period and for at least 90 days after the final dose of investigational medicinal product (IMP), and refrain from donating sperm during this period
    −A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
    i) Not a woman of childbearing potential (WOCBP)
    OR
    ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 90 days after the final dose of IMP

    Part B:
    -Participant must be 18 to 65 years of age inclusive at the time of signing the ICF
    -Participant has a documented history of moderate or severe AtD that has been present for at least 12 months prior to initiating the study (signing of the ICF) and with:
    • validated Investigator Global Assessment (vIGA) score ≥3 at Screening (Visit 1) and Baseline (Visit 2)
    • Eczema Area and Severity Index (EASI) score of ≥14 at Screening (Visit 1) and ≥16 at Baseline (Visit 2)
    • Pruritus Numerical Rating Scale (NRS) score ≥ 3 at Screening (Visit 1) and Baseline (Visit 2)
    • ≥10% body surface area (BSA) of AtD involvement at Screening (Visit 1) and Baseline (Visit 2)
    • Either documented recent history (within 6 months before the Screening Visit) of inadequate response to treatment with topical medications (regular use of topical corticosteroids [TCS] or topical calcineurin inhibitors [TCIs]) or when topical treatments are confirmed to be otherwise medically inadvisable (eg, because of important side effects or safety risks). Inadequate response is defined as failure to achieve and maintain remission or low disease remission or a low disease activity state (vIGA 0=clear to vIGA 2=mild) despite treatment with a daily regimen of TCS of medium to higher potency (±TCI as appropriate), applied for at least 4 weeks or for the maximum duration recommended by the product prescribing information (eg, 2 weeks for high potency TCS), whichever is shorter.
    -Participant has a body mass index (BMI) within the range 18 to 32 kg/m^2 (inclusive)
    -Participant can be male or female
    −A male participant must agree to use contraception during the Treatment Period and for at least 60 days after the final dose of IMP, and refrain from donating sperm during this period
    −A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
    i) Not a woman of childbearing potential (WOCBP)
    OR
    ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 60 days after the final dose of IMP
    Parte A:
    -El participante debe tener entre 18 y 55 años (ambos inclusive) en el momento de firmar el formulario de consentimiento informado (ICF)
    -El participante debe estar manifiestamente saludable según lo determinado por una evaluación médica que incluya historial médico, examen físico, pruebas de laboratorio y monitorización cardíaca.
    -El participante tiene un índice de masa corporal (IMC) dentro del rango de 18 a 30 kg/m2 (inclusive)
    -El participante puede ser hombre o mujer.
    − Un participante masculino debe aceptar usar anticonceptivos durante el Período de tratamiento y durante al menos 90 días después de la dosis final del medicamento en investigación (IMP), y abstenerse de donar esperma durante este período.
    − Una participante femenina es elegible para participar si no está embarazada, no está amamantando y se aplica al menos 1 de las siguientes condiciones:
    i) No es una mujer en edad fértil
    O
    ii) Es una mujer en edad fértil que acepta seguir la guía anticonceptiva durante el período de tratamiento y durante al menos 90 días después de la dosis final de IMP

    Parte B:
    -El participante debe tener entre 18 y 65 años (ambos inclusive) en el momento de firmar el ICF
    -El participante tiene antecedentes documentados de dermatitis atópica (AtD) moderada o grave que ha estado presente durante al menos 12 meses antes de iniciar el estudio (firma del ICF) y con:
    • Puntuación ≥3 de la evaluación global del investigador validada (vIGA) en la selección (visita 1) y al inicio (visita 2)
    • Puntuación del índice de gravedad y área del eccema (EASI) de ≥14 en la selección (visita 1) y ≥16 al inicio (visita 2)
    • Puntuación de la escala de calificación numérica (NRS) del prurito ≥ 3 en la selección (visita 1) y al inicio (visita 2)
    • >=10 % del área de superficie corporal (BSA) con AtD en la selección (visita 1) y al inicio (visita 2)
    • Historial reciente documentado (dentro de los 6 meses anteriores a la visita de selección) de respuesta inadecuada al tratamiento con medicamentos tópicos (uso regular de corticosteroides tópicos [TCS] o inhibidores de calcineurina tópicos [TCI]) o cuando se confirma que los tratamientos tópicos son médicamente desaconsejables por otros motivos (por ejemplo, debido a efectos secundarios importantes o riesgos de seguridad). La respuesta inadecuada se define como la imposibilidad de lograr y mantener la remisión o una baja remisión de la enfermedad o un estado de baja actividad de la enfermedad (vIGA 0 = claro a vIGA 2 = leve) a pesar del tratamiento con un régimen diario de TCS de potencia media a alta (±TCI según corresponda). ), aplicado durante al menos 4 semanas o durante la duración máxima recomendada por la información de prescripción del producto (p. ej., 2 semanas para TCS de alta potencia), lo que sea más corto.
    -El participante tiene un índice de masa corporal (IMC) dentro del rango de 18 a 32 kg/m2 (inclusive)
    -El participante puede ser hombre o mujer.
    −Un participante masculino debe aceptar usar anticonceptivos durante el Período de tratamiento y durante al menos 60 días después de la dosis final de IMP, y abstenerse de donar esperma durante este período
    − Una participante femenina es elegible para participar si no está embarazada, no está amamantando y si aplica al menos 1 de las siguientes condiciones:
    i) No es una mujer en edad fértil
    O
    ii) Es una mujer en edad fértil que acepta seguir la guía anticonceptiva durante el período de tratamiento y durante al menos 60 días después de la dosis final de IMP
    E.4Principal exclusion criteria
    Part A:
    -Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) or other biologic drugs as stated in this protocol
    -Participant has a significant allergy to humanized monoclonal antibodies (mAbs)
    -Participant has clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions
    -Participant has abnormal blood pressure (BP; outside the normal range) in a supine position after 5 minutes rest
    - Participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline
    phosphatase (ALP) >1.0x upper limit of normal (ULN)
    -Participant has a recent history or currently active clinically-significant bacterial, fungal, endoparasite, or viral (including hospitalization for coronavirus disease 2019 (COVID-19)) infection (within 6 months of the Screening Visit)
    -Participant has a history of inflammatory bowel disease (includes Crohn’s disease and ulcerative colitis)
    -Participant has a history of diabetes
    -Participant has a corrected QT interval (QTc) >450 msec
    -Participant has received any prescription or nonprescription medicines, including over the counter remedies and herbal and dietary supplements (other than vitamins within recommended daily dose limits), within 14 days (or 5 half-lives of the respective drug, whichever is longer) prior to the Baseline Visit, other than contraceptives (oral, implants, or intrauterine devices) or occasional use of analgesics, such as paracetamol (acetaminophen, with or without caffeine, with a maximal dose of 4 g/day and 10 g/14 days)
    -Participant has received Bacillus Calmette-Guerin vaccinations within 1 year prior to the Baseline Visit or within 90 days after the final dose of IMP
    -Participant has been treated with biologic agents (such as mAbs, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to the Baseline Visit
    -Participant has participated in another study of an IMP within the previous 90 days or 5 half-lives of the IMP (whichever longer), or is currently participating in another study of an IMP
    -Participant has sensitivity to heparin or heparin-induced thrombocytopenia

    Part B:
    -Participant has a known hypersensitivity to any components of the IMP or other biologic drugs as stated in this protocol
    -Participant has significant allergies to humanized mAbs
    -Participant has clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis)
    -Participant has abnormal BP (outside the normal range) in a supine position after 5 minutes rest
    - Participant has ALT, AST, or ALP >1.5xULN
    -Participant has a recent history of or clinically active clinically-significant bacterial, fungal, endoparasite, or viral (or any history of hospitalization for COVID-19) infection (within 6 months of the Screening Visit)
    -Participant has a history of inflammatory bowel disease (includes Crohn’s disease and ulcerative colitis)
    -Participant has a history of diabetes that is not well controlled with diet
    -Participant has a mean QTc >450 msec for male study participants or >470 msec for female study participants.
    -Participant has received any prescription or nonprescription medicines, including over the counter remedies and herbal and dietary supplements (other than vitamins within recommended daily dose limits) within 14 days (or 5 half-lives of the respective drug, whichever is longer) prior to the Baseline Visit, other than contraceptives (oral, implants, or intrauterine devices) or occasional use of analgesics such as paracetamol (acetaminophen, with or without caffeine, with a maximal dose of 4 g/day and 10 g/14 days) or intranasal corticosteroids for seasonal rhinitis or inhaled bronchodilators and low dose inhaled corticosteroids for mild asthma
    -Participant has received Bacillus Calmette-Guerin vaccinations within 1 year prior to the Baseline Visit or is anticipated to do so within 60 days after the final dose of IMP
    -Participant has been treated with biologic agents (such as mAbs, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to the Baseline Visit
    -Participant has participated in another study of an IMP within the previous 30 days or 5 half-lives of IMP (whichever longer) from the Baseline visit or is currently participating in another study of an IMP
    -Participant has sensitivity to heparin or heparin-induced thrombocytopenia
    Parte A:
    -El participante tiene una hipersensibilidad conocida a cualquiera de los componentes del medicamento en investigación (IMP) u otros medicamentos biológicos como se indica en este protocolo
    -El participante tiene una alergia significativa a los anticuerpos monoclonales humanizados (mAb)
    - El participante tiene alergias múltiples o graves a medicamentos clínicamente significativas, intolerancia a los corticosteroides tópicos o reacciones graves de hipersensibilidad posteriores al tratamiento
    -El participante tiene presión arterial anormal (PA; fuera del rango normal) en posición supina después de 5 minutos de descanso
    - El participante tiene alanina aminotransferasa (ALT), aspartato aminotransferasa (AST) o alcalina
    fosfatasa (ALP) >1.0x límite superior normal (ULN)
    -El participante tiene un historial reciente o una infección bacteriana, fúngica, endoparásita o viral clínicamente significativa actualmente activa (incluida la hospitalización por enfermedad por coronavirus 2019 (COVID-19)) (dentro de los 6 meses posteriores a la visita de selección)
    -El participante tiene antecedentes de enfermedad inflamatoria intestinal (incluye enfermedad de Crohn y colitis ulcerosa)
    -El participante tiene antecedentes de diabetes.
    -El participante tiene un intervalo QT corregido (QTc) >450 ms
    -El participante ha recibido medicamentos recetados o de venta libre, incluidos remedios de venta libre y suplementos herbales y dietéticos (que no sean vitaminas dentro de los límites de dosis diaria recomendada), dentro de los 14 días (o 5 vidas medias del medicamento respectivo, lo que sea más largo) antes a la Visita de Base, distintos de los anticonceptivos (orales, implantes o dispositivos intrauterinos) o el uso ocasional de analgésicos, como el paracetamol (acetaminofén, con o sin cafeína, con una dosis máxima de 4 g/día y 10 g/14 días)
    -El participante ha recibido vacunas Bacillus Calmette-Guerin dentro del año anterior a la visita inicial o dentro de los 90 días posteriores a la dosis final de IMP
    -El participante ha sido tratado con agentes biológicos (como mAbs, incluidos los medicamentos comercializados) dentro de los 3 meses o 5 semividas (lo que sea más largo) antes de la visita inicial
    -El participante ha participado en otro estudio de un IMP dentro de los 90 días anteriores o 5 vidas medias del IMP (lo que sea más largo), o está participando actualmente en otro estudio de un IMP
    -El participante tiene sensibilidad a la heparina o trombocitopenia inducida por heparina

    Parte B:
    -El participante tiene una hipersensibilidad conocida a cualquiera de los componentes del IMP u otros medicamentos biológicos como se indica en este protocolo
    -El participante tiene alergias significativas a anticuerpos monoclonales humanizados (mAbs)
    - El participante tiene alergias múltiples o graves a medicamentos clínicamente significativas, o reacciones graves de hipersensibilidad posteriores al tratamiento (que incluyen, entre otras, eritema multiforme mayor, dermatosis por inmunoglobulina A lineal (IgA), necrólisis epidérmica tóxica y dermatitis exfoliativa)
    -El participante tiene una presión arterial (PA) anormal (fuera del rango normal) en una posición supina después de 5 minutos de descanso
    - El participante tiene alanina aminotransferasa (ALT), aspartato aminotransferasa (AST) o fosfatasa alcalina (ALP) >1.5x el límite superior de lo normal.
    -El participante tiene un historial reciente de infección bacteriana, fúngica, endoparásita o viral clínicamente activa o clínicamente significativa (o cualquier historial de hospitalización por COVID-19) (dentro de los 6 meses posteriores a la visita de selección)
    -El participante tiene antecedentes de enfermedad inflamatoria intestinal (incluye enfermedad de Crohn y colitis ulcerosa)
    -El participante tiene antecedentes de diabetes que no se controla bien con la dieta.
    -El participante tiene un intervalo QT corregido (QTc) medio >450 mseg para los participantes masculinos del estudio o >470 mseg para las participantes femeninas del estudio.
    -El participante ha recibido medicamentos recetados o de venta libre, incluidos remedios de venta libre y suplementos herbales y dietéticos (que no sean vitaminas dentro de los límites de dosis diaria recomendados) dentro de los 14 días (o 5 vidas medias del medicamento respectivo, lo que sea más largo) antes de la Visita Basal, distintos a anticonceptivos (orales, implantes o dispositivos intrauterinos) o uso ocasional de analgésicos como paracetamol (paracetamol, con o sin cafeína, con una dosis máxima de 4 g/día y 10 g/14 días) o analgésicos intranasales corticosteroides para la rinitis estacional o broncodilatadores inhalados y dosis bajas de corticosteroides inhalados para el asma leve
    -El participante ha recibido vacunas Bacillus Calmette-Guerin dentro de 1 año antes de la visita inicial o se prevé que lo haga dentro de los 60 días posteriores a la dosis final de IMP


    Para más información ver protocolo
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidents of treatment-emergent adverse events (TEAEs) during Part A
    2. Incidents of treatment-emergent serious adverse events (TESAEs) during Part A
    3. Incidents of TEAEs during Part B
    4. Incidents of TESAEs during Part B
    5. ≥75% improvement vs Baseline in Eczema Area and Severity Index (EASI75) score during Part B
    1. Incidentes de eventos adversos emergentes del tratamiento (TEAE) durante la Parte A
    2. Incidentes de eventos adversos graves emergentes del tratamiento (TESAE) durante la Parte A
    3. Incidentes de TEAEs durante la Parte B
    4. Incidentes de TESAEs durante la Parte B
    5. ≥75 % de mejora frente al valor inicial en la puntuación del Índice de gravedad y área del eccema (EASI75) durante la Parte B
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-2: From Baseline up to the End of Study Visit (Week 12)
    3-4: From Baseline up to the End of Study Visit (Week 18)
    5: Baseline, Week 12
    1-2: Desde el inicio hasta el final de la visita del estudio (semana 12)
    3-4: Desde el inicio hasta el final de la visita de estudio (semana 18)
    5: línea de base, semana 12
    E.5.2Secondary end point(s)
    1. Cmax from Baseline through the End of Study (EoT) Visit of Part A
    2. Tmax from Baseline through the End of Study (EoT) Visit of Part A
    3. AUC(0-t) from Baseline through the End of Study (EoT) Visit of Part A
    4. AUC from Baseline through the End of Study (EoT) Visit of Part A
    5. F% from Baseline through the End of Study (EoT) Visit of Part A
    6. Percent change from Baseline in the Eczema Area and Severity Index (EASI) score at Week 12 of Part B
    7. ≥50% improvement vs Baseline in EASI score (EASI50) at Week 12 during Part B
    8. ≥90% improvement vs Baseline in EASI score (EASI90) at Week 12 during Part B
    9. Cmax after the final dose of Part B
    10. Tmax after the final dose of Part B
    11. AUCtau at Week 12 of Part B
    1. Cmax desde el inicio hasta la visita de fin de estudio (EoT) de la Parte A
    2. Tmax desde el inicio hasta la visita de fin de estudio (EoT) de la Parte A
    3. AUC(0-t) desde el inicio hasta la visita de fin de estudio (EoT) de la Parte A
    4. AUC desde el inicio hasta la visita de fin de estudio (EoT) de la Parte A
    5. F% desde el inicio hasta la visita de fin de estudio (EoT) de la Parte A
    6. Cambio porcentual desde el inicio en la puntuación del índice de gravedad y área del eccema (EASI) en la semana 12 de la parte B
    7. ≥50 % de mejora frente al valor inicial en la puntuación EASI (EASI50) en la semana 12 durante la Parte B
    8. ≥90 % de mejora frente al valor inicial en la puntuación EASI (EASI90) en la semana 12 durante la Parte B
    9. Cmax después de la dosis final de la Parte B
    10. Tmax después de la dosis final de la Parte B
    11. AUCtau en la Semana 12 de la Parte B
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- 5: From Baseline through the End of Study Visit (Week 12)
    6 - 8: Baseline, Week 12
    9 - 11: Week 12
    1- 5: desde el inicio hasta el final de la visita del estudio (semana 12)
    6 - 8: línea de base, semana 12
    9 - 11: Semana 12
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability and immunogenicity
    Tolerabilidad e inmunogenicidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 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 trial11
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Poland
    Bulgaria
    Netherlands
    Spain
    Germany
    Belgium
    United Kingdom
    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 years0
    E.8.9.1In the Member State concerned months6
    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 months11
    E.8.9.2In all countries concerned by the trial days17
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 159
    F.4.2.2In the whole clinical trial 159
    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.
    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 Decision2023-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-20
    P. End of Trial
    P.End of Trial StatusOngoing
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