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    EudraCT Number:2021-006413-11
    Sponsor's Protocol Code Number:CDX0159-06
    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:2022-05-30
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2021-006413-11
    A.3Full title of the trial
    A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Assess the Efficacy and Safety of CDX-0159 in Patients with Chronic Spontaneous Urticaria
    Estudio de fase II de búsqueda de dosis, aleatorizado, doble ciego y controlado con un placebo, para evaluar la eficacia y la seguridad del CDX-0159 en pacientes con urticaria crónica espontánea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Assess the Efficacy and Safety of CDX-0159 in Patients with Chronic Spontaneous Urticaria
    Estudio de fase II de búsqueda de dosis, aleatorizado, doble ciego y controlado con un placebo, para evaluar la eficacia y la seguridad del CDX-0159 en pacientes con urticaria crónica espontánea
    A.4.1Sponsor's protocol code numberCDX0159-06
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05368285
    A.5.4Other Identifiers
    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 SponsorCelldex Therapeutics
    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 supportCelldex Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelldex Therapeutics, Inc.
    B.5.2Functional name of contact pointElsa Paradise
    B.5.3 Address:
    B.5.3.1Street Address160 Gould Street Suite 202
    B.5.3.2Town/ cityNeedham
    B.5.3.3Post code02494
    B.5.3.4CountryUnited States
    B.5.4Telephone number17814654940
    B.5.5Fax number12032081533
    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 namebarzolvolimab
    D.3.2Product code barzolvolimab
    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 INNCDX-0159
    D.3.9.1CAS number 2438203-51-9
    D.3.9.2Current sponsor codeCDX-0159
    D.3.9.3Other descriptive nameHumanised IgG1k monoclonal antibody against KIT
    D.3.9.4EV Substance CodeSUB219179
    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. 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 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
    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
    Chronic Spontaneous Urticaria
    Urticaria Crónica Espontánea
    E.1.1.1Medical condition in easily understood language
    Long-lasting hives with an unknown cause
    Urticaria de larga duración de causa desconocida
    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 10052568
    E.1.2Term Urticaria chronic
    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 evaluate efficacy of different dose regimens of CDX-0159, compared to placebo, in reducing urticaria activity as assessed by urticaria activity score (UAS) in patients with CSU refractory to H1AH therapy
    Evaluar la eficacia de diferentes pautas posológicas de CDX-0159, en comparación con un placebo, para reducir la actividad urticarial, evaluada con la escala Urticaria Activity Score (UAS), en pacientes con urticaria crónica espontánea (UCE) resistente al tratamiento con antihistamínicos H1
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of different dose regimens of CDX-0159, compared to placebo, in reducing itch severity as assessed by itch severity score (ISS) in CSU patients
    •To evaluate the efficacy of different dose regimens of CDX-0159, compared to placebo, in reducing hive severity as assessed by hive severity score (HSS) in CSU patients
    •To evaluate the efficacy of different dose regimens of CDX-0159, compared to placebo, in reducing angioedema severity as assessed by angioedema activity score (AAS) in CSU patients
    •To evaluate the long-term (up to 52 weeks) efficacy of different dose regimens of CDX-0159 in CSU patients
    •To evaluate the safety profile of different dose regimens of CDX-0159, compared to placebo, in CSU patients
    •To evaluate the long-term (up to 52 weeks) safety profile of different dose regimens of CDX-0159 in CSU patients
    -la eficacia de diferentes pautas posológicas de CDX-0159, en comparación con un placebo, para reducir la intensidad del prurito, evaluada con la escala Itch Severity Score (ISS), en pacientes con UCE
    -la eficacia de diferentes pautas posológicas de CDX-0159, en comparación con un placebo, para reducir la gravedad de los habones, evaluada con la escala Hive Severity Score (HSS), en pacientes con UCE
    -la eficacia de diferentes pautas posológicas de CDX-0159, en comparación con un placebo, para reducir la gravedad del angioedema, evaluada con la escala Angioedema Activity Score (AAS), en pacientes con UCE
    -la eficacia a largo plazo (hasta 52 semanas) de las diferentes pautas posológicas de CDX-0159 en pacientes con UCE
    -el perfil toxicológico de las diferentes pautas posológicas de CDX-0159, en comparación con un placebo, en pacientes con UCE
    -el perfil toxicológico a largo plazo (hasta 52 semanas) de las diferentes pautas posológicas de CDX-0159 en pacientes con UCE
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Additional PK/tryptase samples are being taken in U.S., Germany, and South Africa (optional particpation). For this CTA, this would apply to Germany.
    Adicionalmente se están tomando muestras para el análisis de proteína quinasa/triptasa en EEUU, Alemania y Sudáfrica (participación opcional). Para esta solicitud, se aplicaría en Alemania.
    E.3Principal inclusion criteria
    1.Read, understood, and provided written informed consent, and Health Insurance Portability and Accountability Act (HIPAA) authorization if applicable, after the nature of the study has been fully explained.
    2.Male or female, ≥ 18 years of age at the time of signing the informed consent
    3.Diagnosis of CSU ≥ 6 months prior to Screening Visit 1
    4.CSU refractory to a stable regimen of second-generation non-sedating H1AH as defined by all of the following:
    •Recurrent pruritic wheals with or without angioedema for ≥ 6 weeks at any time prior to Screening Visit 1 despite treatment with a H1AH
    Note: Hives consistent with CSU should be documented and confirmed by the investigator prior to randomization
    •Patients must have been on a stable regimen of daily use of a second-generation non-sedating H1AH at approved or increased (up to 4 times the approved) dose for the treatment of CSU for ≥ 4 weeks prior to randomization and which is expected to remain stable at the time of randomization and throughout the study
    •Weekly urticaria activity score (UAS7, range: 0-42) ≥ 16 and weekly itch severity score (ISS7, range: 0-21) ≥ 8 during the 7-day period immediately prior to randomization
    5.Hemoglobin, white blood count (WBC), absolute neutrophil count (ANC), and platelets above the lower limit of normal (LLN) and less than 1.2 X the upper limit of normal (ULN) range if the higher values are deemed to be not clinically significant by the Investigator, at Screening Visits 1 and 2*
    6.Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2 x ULN, and total bilirubin < ULN, at Screening Visits 1 and 2*.
    *For 5 and 6 above, if test results do not meet the above criteria, a repeat test may be performed to establish eligibility.
    7.Females must meet one of the following criteria:
    If of childbearing potential, agree to use highly effective contraception from the time of Screening Visit 1 and for at least 150 days after receipt of study treatment. Highly effective methods of contraception include the following:
    •combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, administered as oral, intravaginal or transdermal
    •progestogen-only hormonal contraception associated with inhibition of ovulation administered as oral, injectable or by implantable means
    •intrauterine device (IUD)
    •intrauterine hormone-releasing system (IUS)
    Females of non-childbearing potential, who are surgically sterile (i.e., had undergone complete hysterectomy, salpingectomy and bilateral oophorectomy) or in a menopausal state (at least 1 year without menses), as confirmed by FSH levels, are eligible.
    8.Male patients must agree that while participating in the study and for at least 150 days after receipt of the study treatment, they will use highly effective methods of contraception with female partners of childbearing potential, and they will not donate sperm. Vasectomy is considered to be a highly effective method of contraception.
    9.Willing and able to comply with all study requirements and procedures, including the completion of a daily symptom diary during screening and throughout the study. Note: For study eligibility, patients need to complete the diary for at least 6 of 7 days immediately prior to randomization.
    1.Haber leído, comprendido y otorgado el consentimiento informado y la autorización a efectos de la Ley de Responsabilidad y Portabilidad de los Seguros Médicos (de Estados Unidos), si procede, después de recibir una explicación a fondo sobre el ensayo
    2.Sexo masculino o femenino y edad ≥18 años en el momento de firmar el consentimiento informado
    3.Diagnóstico de UCE ≥6 meses antes de la 1ª visita de selección
    4.UCE resistente a una pauta estable de antihistamínicos H1 no sedantes de segunda generación, definida por lo siguiente:
    •Habones pruriginosos recurrentes, acompañados o no de angioedema, durante ≥6 semanas, en cualquier momento antes de la 1ª visita de selección, a pesar del tratamiento con un antihistamínico H1
    Nota: El investigador debe documentar y confirmar la presencia de habones compatibles con la UCE antes de la aleatorización
    •Tratamiento con un antihistamínico H1 no sedante de segunda generación ≥4 semanas en el momento de la aleatorización, con una pauta diaria y con la dosis autorizada o incrementada (máx. cuatro veces la dosis autorizada), y previsión de mantener la misma pauta durante todo el ensayo
    •Puntuación semanal de actividad urticarial ≥16 (UAS-7, intervalo: 0-42) y puntuación semanal del prurito ≥8 (ISS-7, intervalo: 0-21) en los siete días inmediatamente anteriores a la aleatorización
    5.Hemoglobina, leucocitos, cifra absoluta de neutrófilos y plaquetas por encima del límite inferior de la normalidad (LIN) y como mucho 1,2 veces por encima del límite superior (LSN), siempre que los valores más altos no revistan relevancia clínica a juicio del investigador, en la 1ª y la 2ª visitas de selección*
    6.Aspartato-aminotransferasa (AST) y alanina-aminotransferasa (ALT) ≤2 × LSN, y bilirrubina total por debajo del LSN, en la 1ª y la 2ª visitas de selección*
    *Si los resultados no se ajustan a lo indicado en los criterios 5º y 6º, se permite repetir la analítica.
    7.En el caso de las mujeres, uno de los criterios siguientes:
    En caso de tener capacidad de concebir, comprometerse a utilizar anticonceptivos de gran eficacia a partir de la 1ª visita de selección y durante 150 días, como mínimo, después del tratamiento en estudio. Los métodos de gran eficacia son:
    •anticonceptivos hormonales combinados (estrógenos y progestágenos), de administración oral, intravaginal o transdérmica y asociados a la anovulación constante;
    •preparados sólo de progestágenos, de administración oral, inyectable e implantable y asociados con la anovulación constante;
    •dispositivo intrauterino (DIU);
    •sistema intrauterino (SIU) de liberación de hormonas.
    En caso de no ser fértiles, haberse sometido a una esterilización quirúrgica (histerectomía completa, salpingectomía y ooforectomía bilateral) o haber pasado la menopausia (al menos un año de amenorrea), con confirmación según los niveles de hormona foliculoestimulante (FSH)
    8.En el caso de los varones, abstenerse de donar esperma y comprometerse a utilizar anticonceptivos de gran eficacia en sus relaciones con mujeres fértiles, durante su participación en el ensayo y durante los 150 días posteriores al tratamiento en estudio. La vasectomía se considera un método de gran eficacia.
    9.Voluntad y capacidad de ceñirse a los requisitos y las actividades del protocolo, incluida la cumplimentación del diario de síntomas durante la fase de selección y a lo largo del ensayo
    Nota: Para determinar su idoneidad de cara a la participación, los pacientes tendrán que cumplimentar el diario al menos seis días de los siete anteriores a la aleatorización
    E.4Principal exclusion criteria
    1.Diseases with possible symptoms of urticaria or angioedema such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), autoimmune syndromes with urticarial lesions (e.g., Schnitzler Syndrome) and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency).
    2.Active chronic inducible urticaria (CIndU) including symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria that would confound CSU assessments based on the investigator’s clinical judgment.
    3.Any other active pruritic skin diseases that would confound CSU assessments (e.g., atopic dermatitis, psoriasis, bullous pemphigoid, dermatitis herpetiformis, prurigo nodularis, chronic pruritus of unknown origin) based on the investigator's clinical judgment
    4.Regular (3 or more days a week) use of topical corticosteroid, topical calcineurin inhibitors or topical antihistamines, first-generation sedating antihistamines (e.g., diphenhydramine, hydroxyzine, doxylamine) and other sedatives/hypnotics (e.g., doxepin), within 1 week of Screening Visit 1.
    5.Phototherapy with ultraviolet (UV) A or UVB within 4 weeks of Screening Visit 1.
    6.Non-biologic systemic (oral or injectable) agents listed below, including investigational agents, within 4 weeks or 5 half-lives, whichever is longer, prior to Screening Visit 1.
    Note: Non-biologic systemic (oral or injectable) agents: corticosteroids, non-steroidal immunosuppressants (e.g., methotrexate, cyclosporin, tacrolimus, mycophenolate mofetil, azathioprine, cyclophosphamide), and other immunomodulators (e.g., dapsone, sulfasalazine, hydroxychloroquine, and colchicine, Jak inhibitors, Bruton's kinase [BTK] inhibitors), anticoagulants (e.g., warfarin), antifibrinolytic agents (e.g., tranexamic acid), mast cell stabilizers (e.g., cromolyn, ketotifen), and other investigational agents
    7.Biologic therapy including approved or investigational biologic agents (e.g., omalizumab, ligelizumab, dupilumab, interleukin (IL)-1 inhibitor, tumor necrosis factor (TNF) inhibitor, B-cell depleting therapy (e.g., rituximab), or other investigational monoclonal antibodies, intravenous immunoglobulin (IVIG) therapy or plasmapheresis within 3 months or 5 half-lives, whichever is longer, prior to Screening Visit 1.
    8.Receipt of a live vaccine within 2 months prior to the Baseline (Day 1) Visit (patients must agree to avoid live vaccination during study treatment and within 3 months thereafter).
    Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally inactivated virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Currently authorized COVID-19 vaccines are allowed.
    9.Planned or anticipated use of any prohibited medications during screening and study treatment, and follow-up.
    10.Diagnosis of idiopathic anaphylaxis or a history of anaphylaxes (such as those due to Hymenoptera venom or IgE-mediated food allergy), that in the opinion of the investigator, could increase the patient’s risk for systemic hypersensitivity reactions; or any known contraindications or hypersensitivity to any component of study treatments, drugs of similar chemical classes (i.e., to murine, chimeric or human antibodies) or antihistamines.
    11.Women who are pregnant or nursing. All female patients with reproductive potential must have a negative pregnancy test prior to starting study treatment.
    12.Severe or uncontrolled chronic diseases (e.g., chronic hepatic or renal disease, diabetes mellitus) that might interfere with the evaluation of the clinical effect or safety of study treatment.
    13.Known active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
    14.Patients with active COVID-19 infection.
    15.History of malignancy within 5 years before Screening Visit 1, except fully treated carcinoma in-situ of the cervix, fully treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
    16.Other screening laboratory or electrocardiogram (ECG) findings that are considered clinically significant.
    17.Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals during the Screening period.
    18.Any other acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study.
    More criteria can be found in Synopsis (19 to 22)
    1.Enfermedades que pueden cursar con síntomas de urticaria o angioedema, como vasculitis urticarial, eritema multiforme, mastocitosis cutánea (urticaria pigmentosa), síndromes autoinmunitarios con lesiones urticariales (p.ej. síndrome de Schnitzler) y angioedema hereditario o adquirido (p.ej. por déficit de inhibidores del C1)
    2.Urticaria crónica inducible (UCI) activa, incluidos los dermografismos sintomáticos (urticaria facticia) y la urticaria por frío, calor, radiación solar, presión o presión retardada, así como las urticarias acuógena, colinérgica y de contacto, siempre que, a juicio del investigador, vayan a entorpecer las evaluaciones de la UCE
    3.Otras dermatosis pruríticas activas que entorpezcan las evaluaciones de la UCE (p.ej. dermatitis atópica, psoriasis, penfigoide ampolloso, dermatitis herpetiforme, prurigo nodular, prurito crónico idiopático, etc.), según el criterio clínico del investigador
    4.Consumo regular (3 días a la semana o más) de corticoides tópicos, antihistamínicos tópicos, inhibidores de la calcineurina tópicos, antihistamínicos sedantes de primera generación (p.ej. difenhidramina, hidroxizina, doxilamina) y otros sedantes o hipnóticos (p.ej. doxepina) en la semana anterior a la 1.ª visita de selección.
    5.Fototerapia con rayos ultravioleta (UV) A o UVB en las cuatro semanas anteriores a la 1ª visita de selección.
    6.Tratamiento sistémico (oral o inyectable) con los productos no biológicos indicados a continuación, incluso en fase de investigación, en las 4 semanas antes de la 1ª visita de selección, o 5 semividas, lo que resulte más prolongado.
    Nota: Los productos sistémicos (orales o inyectables) no biológicos son:corticoesteroides,inmunosupresores no esteroideos (p.ej. metotrexato,ciclosporina,tacrólimus,micofenolato mofetilo,azatioprina,ciclofosfamida) y otros inmunomoduladores (p.ej. dapsona,sulfasalazina,hidroxicloroquina y colchicina,inhibidores de las cinasas Jano,inhibidores de la cinasa de Bruton),anticoagulantes (p. ej., warfarina),antifibrinolíticos(p.ej. ácido tranexámico),estabilizadores de los mastocitos(p.ej. cromoglicato,ketotifeno) y otros productos en fase de investigación
    7.Terapia biológica con productos autorizados o en fase de investigación, p.ej. omalizumab,ligelizumab,dupilumab,inhibidores de la interleucina 1,inhibidores del factor de necrosis tumoral α,reductores de los linfocitos B (p.ej. rituximab) u otros anticuerpos monoclonales en fase de investigación,inmunoglobulinas intravenosas o plasmaféresis en los 3 meses antes de la 1ª visita de selección, o bien en las 5 semividas del producto, lo que resulte más prolongado
    8.Administración de vacunas elaboradas con microbios vivos en los 2 meses antes de la visita inicial (día 1); el paciente debe aceptar no ponerse vacunas con microbios vivos durante el tratamiento y los tres meses siguientes.A título no limitativo pueden citarse, como ejemplos de vacunas elaboradas con microbios vivos, las siguientes:antisarampionosa,antiparotidítica,antirrubeólica,antivaricelosa/zóster,antiamarílica,antirrábica,antitifoidea y antituberculosa con bacilo de Calmette y Guérin.Las antigripales estacionales que se administran en inyección suelen ser vacunas de virus inactivados y por tanto están permitidas; por el contrario, las de administración intranasal (como FluMist) están hechas con virus atenuados, por lo que no están permitidas. Se permiten las vacunas autorizadas actualmente contra la COVID-19
    9.Administración prevista o previsible de medicamentos prohibidos durante las fases de selección, tratamiento y seguimiento
    10.Diagnóstico de anafilaxia idiopática o antecedentes de anafilaxias (p.ej. por veneno de himenópteros o alergias alimentarias mediadas por la IgE) que, a juicio del investigador, incrementen el riesgo de hipersensibilidad sistémica, o contraindicaciones o hipersensibilidad a alguno de los ingredientes de los tratamientos estudiados, a los fármacos de clases químicas análogas (p.ej. anticuerpos murinos,quiméricos o humanos) o a los antihistamínicos
    11.Embarazo o lactancia materna en el caso de las mujeres. Antes de iniciar el tratamiento, todas las pacientes que tengan capacidad de procrear deben dar negativo a una prueba de embarazo
    12.Enfermedades crónicas graves o incontroladas (p. ej., hepatopatías o nefropatías crónicas,diabetes mellitus) que puedan entorpecer la evaluación del efecto clínico o de la seguridad del tratamiento en estudio
    13.Infección activa por el virus de la hepatitis B, el virus de la hepatitis C o el virus de la inmunodeficiencia humana (VIH)
    14.COVID-19 activa
    15.Antecedentes de neoplasias malignas en los 5 años anteriores a la 1ª visita de selección, a excepción del carcinoma in situ de cuello uterino que haya sido debidamente tratado y el carcinoma basocelular o espinocelular in situ de la piel, debidamente tratado y resuelto
    Más criterios se encuentran en sinopsis (16 a 22)
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from baseline to Week 12 in UAS7
    Variación media de la puntuación UAS-7 a la semana 12, respecto al valor inicial
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    - Mean change from baseline to Week 12 for ISS7, HSS7, and AAS7.
    - Safety as assessed by adverse events over the treatment periods to Week 16 and Week 52.
    - Variación media desde el inicio a la semana 12 de la ISS7, HSS7 y AAS7
    - Seguridad evaluada por los eventos adversos durante los períodos de tratamiento hasta la Semana 16 y la Semana 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12, and Week 16 through Week 52
    Semana 12 y de la semana 16 hasta la semana 52
    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 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) 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 No
    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 trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    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
    South Africa
    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 visit of the last subject in the study
    Última visita del último paciente en el estudio
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 116
    F.4.2.2In the whole clinical trial 180
    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)
    Hospital standard of care.
    Tratamiento estándar del hospital
    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 Decision2022-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-28
    P. End of Trial
    P.End of Trial StatusOngoing
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