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    Summary
    EudraCT Number:2020-005107-40
    Sponsor's Protocol Code Number:SNDX-6352-0504
    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:2021-07-13
    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 number2020-005107-40
    A.3Full title of the trial
    AGAVE-201, A Phase 2, Open-label, Randomized, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Axatilimab at 3 Different Doses in Patients with Recurrent or Refractory Active Chronic Graft Versus Host Disease who have Received at least 2 Lines of Systemic Therapy
    AGAVE-201, Estudio de fase 2, abierto, aleatorizado y multicéntrico para evaluar la eficacia, la seguridad y la tolerabilidad de axatilimab en 3 dosis diferentes en pacientes con enfermedad del injerto contra el huésped crónica activa recidivante o resistente que han recibido al menos 2 líneas de tratamiento sistémico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2 Study of Axatilimab at 3 Different Doses in Patients with Chronic Graft Versus Host Disease
    Estudio de fase 2 de axatilimab en 3 dosis diferentes en pacientes con enfermedad del injerto contra el huésped crónica
    A.3.2Name or abbreviated title of the trial where available
    AGAVE-201
    A.4.1Sponsor's protocol code numberSNDX-6352-0504
    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 SponsorSyndax Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSyndax Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSyndax Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointChristine Quaranto
    B.5.3 Address:
    B.5.3.1Street Address35 Gatehouse Drive, Building D, Floor 3
    B.5.3.2Town/ cityWaltham
    B.5.3.3Post codeMA 02451
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1781684-9824
    B.5.6E-mailspain.regulatory@medpace.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 nameAxatilimab
    D.3.2Product code SNDX-6352
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAxatilimab
    D.3.9.1CAS number 2155851-88-8
    D.3.9.2Current sponsor codeSNDX-6352
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent/Refractory Active Chronic Graft Versus Host Disease
    Enfermedad del injerto contra el huésped crónica activa recurrente/resistente al tratamiento
    E.1.1.1Medical condition in easily understood language
    Recurrent/Refractory Active Chronic Graft Versus Host Disease
    Enfermedad del injerto contra el huésped crónica activa recurrente/resistente al tratamiento
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10066261
    E.1.2Term Chronic graft versus host disease
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To evaluate the overall response rate (ORR) of axatilimab at 0.3 mg/kg Q2W, 1 mg/kg Q2W, and 3 mg/kg Q4W in patients with cGVHD
    1. Evaluar la tasa de respuesta global (TRG) de axatilimab con 0,3 mg/kg cada dos semanas, 1 mg/kg cada dos semanas y 3 mg/kg cada cuatro semanas en pacientes con EICHc.
    E.2.2Secondary objectives of the trial
    Efficacy:
    1. To evaluate secondary measures of clinical benefit.
    Safety:
    1. To evaluate the safety and tolerability of axatilimab in patients with cGVHD
    2. Bone morphology
    PK/PD:
    1. To assess the plasma population PK (pop PK) profile of axatilimab in patients with cGVHD
    2. To assess pharmacodynamic profile of axatilimab
    3. To determine or assess the changes in monocyte level with response
    4. To determine or assess the baseline in monocyte level with response
    Immunogenicity:
    1. Immunogenicity
    Eficacia:
    1. Evaluar medidas secundarias del beneficio clínico.
    Seguridad:
    1. Evaluar la seguridad y la tolerabilidad de axatilimab en pacientes con EICHc
    2. Morfología ósea
    FC/FD:
    1. Evaluar el perfil farmacocinético poblacional (FCpob) en plasma de axatilimab en pacientes con EICHc
    2. Evaluar el perfil farmacodinámico de axatilimab
    3. Determinar o evaluar las variaciones en el número de monocitos con la respuesta
    4. Determinar o evaluar los valores basales de monocitos con la respuesta
    Inmunogenicidad:
    1. Inmunogenicidad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient must be 2 years of age or older, at the time of signing the informed consent.
    2. Patients who are allogeneic HSCT recipients with active cGVHD requiring systemic immune suppression.
    Active cGVHD is defined as the presence of signs and symptoms of cGVHD per 2014 NIH Consensus Development Project on Criteria for Clinical trials in cGVHD (Jagasia 2015).
    3. Patients with refractory or recurrent active cGVHD after at least 2 lines of systemic therapy.
    - Refractory disease defined as meeting any of the following criteria:
    - The development of 1 or more new sites of disease while being treated for cGVHD.
    - Progression of existing sites of disease despite at least 1 month of standard or investigation therapy for cGVHD.
    - Patients who have not achieved a response within 3 months on their prior therapy for cGVHD and for whom the treating physician believes a new systemic therapy is required.
    - Recurrent cGVHD is active, symptomatic disease (after an initial response to prior therapy) as defined, based on the NIH 2014 consensus criteria, by organ-specific or global assessment or for which the physician believes that a new line of systemic therapy is required.
    4. Patients may have persistent active acute and cGVHD manifestations (overlap syndrome), as defined by 2014 NIH Consensus Development Project on Criteria for Clinical trials in cGVHD.
    5. Karnofsky Performance Scale of ≥60 (if aged 16 years or older); Lansky Performance Score of ≥60 (if aged <16 years).
    6. Adequate organ and bone marrow functions evaluated during the 14 days prior to randomization.
    7. Creatinine clearance (CrCl) ≥50 mL/min/1.73 m^2 based on the Cockcroft-Gault formula in adult patients and Schwartz formula in pediatric patients.
    8. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    9. Concomitant use of CNI or sirolimus is allow but not required.
    9. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. A parent/legal guardian should provide consent for pediatric patients unable to provide consent themselves, in addition, where applicable pediatric patients should sign their own assent form.
    1. Los pacientes deben tener al menos 2 años de edad en el momento de la firma del consentimiento informado.
    2. Pacientes que han recibido un TCMH alogénico, padecen EICHc y requieren inmunosupresión sistémica.
    La EICHc activa se define como la presencia de síntomas o signos de EICHc según el Proyecto de Desarrollo de Consenso de los NIH de 2014 sobre criterios para ensayos clínicos en la EICHc (Jagasia 2015).
    3. Pacientes con EICHc activa recurrente o resistente al tratamiento después de al menos 2 líneas de tratamiento sistémico.
    - La enfermedad resistente al tratamiento se define como aquella que cumple todos los criterios siguientes:
    - La aparición de 1 o más localizaciones nuevas de la enfermedad durante el tratamiento de la EICHc.
    - La progresión de localizaciones existentes de la enfermedad a pesar de haber recibido tratamiento habitual o en investigación contra la EICHc durante un mínimo de 1 mes.
    - Pacientes que no han alcanzado una respuesta en un plazo de 3 meses durante su tratamiento anterior contra la EICHc y en los que el médico encargado de su atención cree que es necesario un nuevo tratamiento sistémico.
    - La EICHc recurrente es una enfermedad activa y sintomática (después de una respuesta inicial al tratamiento anterior), que se define, según los criterios de consenso de 2014 de los NIH, mediante una evaluación general o específica por órganos, o contra la que el médico encargado del tratamiento cree que es necesario un nuevo tratamiento sistémico.
    4. Los pacientes pueden tener manifestaciones de EICHc activa y de EICH aguda (síndrome mixto), como define el Proyecto de Desarrollo de Consenso de los NHI de 2014 sobre criterios para ensayos clínicos en la EICHc.
    5. Puntuación en la Escala del estado funcional de Karnofsky de ≥60 (si el paciente tiene 16 años o más); puntuación en la Escala del estado funcional de Lansky de ≥60 (si el sujeto tiene <16 años).
    6. Funciones orgánicas y medular aceptables, evaluadas durante los 14 días previos a la randomización.
    7. Aclaramiento de creatinina (CrCl) ≥50 ml/min/1,73 m2 según la fórmula de Cockcroft-Gault en pacientes adultos y la fórmula de Schwartz en pacientes pediátricos.
    8. El uso de métodos anticonceptivos por hombres y mujeres debe estar en consonancia con la normativa local sobre métodos anticonceptivos para quienes participan en estudios clínicos.
    9. El uso concomitante de ICN o de sirólimus está permitido pero no es obligatorio.
    9. Capaces de otorgar su consentimiento informado firmado, que incluye el cumplimiento de los requisitos y restricciones enumerados en el documento de consentimiento informado (DCI) y en este protocolo. El padre/madre/tutor legal debe proporcionar el consentimiento para los pacientes pediátricos que no pueden dar por sí mismos el consentimiento; además, cuando corresponda, los pacientes pediátricos deben firmar su propio documento de asentimiento.
    E.4Principal exclusion criteria
    1. Has acute GVHD without manifestations of cGVHD.
    2. Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
    3. History of acute or chronic pancreatitis.
    4. History of myositis.
    5. History or other evidence of severe illness, uncontrolled infection or any other conditions that would make the patient, in the opinion of the Investigator, unsuitable for the study.
    6. Patients with acquired immune deficiency syndrome (AIDS).
    7. Hepatitis B (defined as hepatitis B virus [HBV] surface antigen positive and HBV core antibody positive, with positive HBV deoxyribonucleic acid [DNA], or HBV positive core antibody alone with positive HBV DNA. Hepatitis C (defined as positive hepatitis C [HCV] antibody with positive HCV ribonucleic acid [RNA]).
    8. Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years of randomization, unless previously treated with curative intent and approved by Sponsor’s Medical Monitor (eg, completely resected basal cell or squamous cell carcinoma of the skin, resected in situ cervical malignancy, resected breast ductal carcinoma in situ, or low-risk prostate cancer after curative resection).
    9. Female patient who is pregnant or breastfeeding.
    10. Previous exposure to CSF1-R targeted therapies.
    11. Taking agents other than a corticosteroid and either a CNI or sirolimus is prohibited. See inclusion criteria 9 for guidelines regarding the appropriate use of corticosteroids, CNI, and sirolimus in combination with study treatment.
    12. For approved or commonly used agents, other than corticosteroids, CNI and sirolimus, a washout of 2 weeks or 5 half-lives, whichever is shorter, is required at study enrollment.
    13. Receiving another investigational treatment within 28 days of randomization
    14. Patients should not be participating in any other interventional study. Pediatric patients are encouraged to also participate in the ongoing development studies of the Pediatric cGVHD Symptom Scale (PCSS).
    1. Tiene EICH aguda sin manifestaciones de EICHc.
    2. Cualquier signo (histológico, citogenético, molecular, hematológico o mixto) de recidiva del cáncer subyacente o enfermedad linfoproliferativa postrasplante en el momento del screening.
    3. Antecedentes de pancreatitis crónica o aguda.
    4. Antecedentes de miositis.
    5. Antecedentes de otros signos de enfermedad grave, infección no controlada o cualquier otra afecciones que, en opinión del investigador, haría que el paciente no fuera idóneo para el estudio.
    6. Pacientes con síndrome de inmunodeficiencia adquirida (SIDA).
    7. Hepatitis B (definida como positividad para el antígeno de superficie del virus de la hepatitis B [VHB] y positividad para anticuerpos contra el antígeno central del VHB, con positividad para el ácido desoxirribonucleico [ADN] del VHB, o positividad para el antígeno central contra el VHB con positividad del ADN del VHB) . Hepatitis C (definida como positividad para anticuerpos contra el virus de la hepatitis C [VHC] con positividad para el ácido ribonucleico [ARN] del VHC).
    8. Diagnóstico de otra neoplasia maligna (que no sea la que motivó el trasplante) en los 3 años previos a la randomización, salvo que se hubiera tratado con anterioridad con intención curativa y el Monitor Médico del Promotor lo hubiera aprobado (por ejemplo, carcinoma basocelular o de células escamosas de la piel completamente resecado, cáncer de cuello uterino in situ resecado, carcinoma ductal de mama in situ resecado, o cáncer de próstata de bajo riesgo después de resección curativa).
    9. Paciente femenina que está embarazada o amamantando.
    10. Exposición previa a tratamientos dirigidos contra CSF1-R.
    11. Está prohibido recibir fármacos distintos de corticosteroides, y de un ICN o sirólimus. Consúltense en el criterio de inclusión n.º 9 las pautas relativas al uso apropiado de corticosteroides, ICN y sirólimus en combinación con el tratamiento del estudio.
    12. Para fármacos aprobados o utilizados habitualmente (distintos de corticosteroides, ICN y sirólimus), es necesario un período de reposo farmacológico de 2 semanas o 5 semividas, lo que sea más corto, en el momento de la inclusión en el estudio.
    13. Recibir otro tratamiento en investigación en los 28 días previos a la randomización.
    14. Los pacientes no deben estar participando en ningún otro estudio intervencionista. Se insta a los pacientes pediátricos a que participen también en los estudios de desarrollo en curso de la Escala de síntomas de la EICHc pediátrica (Pediatric cGVHD Symptom Scale, PCSS)
    E.5 End points
    E.5.1Primary end point(s)
    1. ORR in the first 6 cycles as defined by the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD.
    1.TRG en los primeros 6 ciclos como se define en el Proyecto de Desarrollo de Consenso de los NIH de 2014 sobre criterios para ensayos clínicos en la EICHc.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. During the first 6 cycles, where the first 6 cycles is defined as the time from randomization up to Day 169 or the beginning of Cycle 7.
    1. Durante los primeros 6 ciclos, definiéndose los primeros 6 ciclos como el tiempo transcurrido desde la randomización hasta el Día 169 o el comienzo del Ciclo 7.
    E.5.2Secondary end point(s)
    Efficacy:
    1. Proportion of patients with a >5-point improvement in modified Lee Symptom Scale Score (mLSS).
    2. ORR on study as defined by the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD.
    3. Duration of response (DOR) defined as the time from best response of PR or CR until documented progression of cGVHD, start of new therapy, or death for any cause (Definition 1)
    4. DOR defined as the time from initial response of PR or CR until documented progression of cGVHD, start of new therapy, or death for any reason (Definition 2)
    5. Sustained response rate (SRR)
    6. Organ-specific response rate based on 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD
    7. Joints and fascia response rate based on refined NIH response algorithm for cGVHD
    8. Percent reduction in average daily dose (or equivalent) of corticosteroids
    9. Proportion of patients who discontinue corticosteroid use after study entry
    10. Percent reduction in average daily dose (or equivalent) of calcineurin inhibitors
    11. Proportion of patients who discontinue calcineurin inhibitors use after study entry

    Safety:
    1. Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)
    2. Change from baseline in values for vital signs, safety laboratory parameters, physical and neurological examination, ECG and Karnofsky/Lansky performance scale
    3. Change from baseline in bone turnover markers
    4. Change from baseline in bone density

    Pharmacodynamics (PK)
    1. Axatilimab PK parameters and patient factors that may explain variability in drug exposure
    2. Change from baseline in colony stimulating factor 1 (CSF-1), interleukin 34 (IL-34) levels and its association with cGVHD response
    3. Change from baseline in circulating monocyte number and phenotype (CD14/16)
    4. Baseline circulating monocyte number and phenotype (CD14/16)

    Immunogenicity:
    1. Presence of anti-drug antibody (ADA)
    Eficacia:
    1. Porcentaje de pacientes con una mejoría de 5 puntos en la puntuación en la Escala de síntomas de Lee modificada (modified Lee Symptom Scale Score, mLSS).
    2. TRG durante el estudio, como se define en el Proyecto de Desarrollo de Consenso de los NIH de 2014 sobre criterios para ensayos clínicos en la EICHc.
    3. Duración de la respuesta (DR), definida como el tiempo transcurrido desde la mejor respuesta de RP o RC hasta la progresión documentada de la EICHc, el inicio de un nuevo tratamiento o el fallecimiento por cualquier causa (Definición 1).
    4. DR, definida como el tiempo transcurrido desde la respuesta inicial de RP o RC hasta la progresión documentada de la EICHc, el inicio de un nuevo tratamiento o el fallecimiento por cualquier causa (Definición 2).
    5. Tasa de respuesta mantenida (TRM).
    6. Tasa de respuesta específica por órganos basada en el Proyecto de Desarrollo de Consenso de los NIH de 2014 sobre criterios para ensayos clínicos en la EICHc.
    7. Tasa de respuesta en articulaciones y aponeurosis basada en algoritmo de respuesta perfeccionado de los NIH para la EICHc.
    8. Reducción porcentual de la dosis diaria media (o equivalente) de corticosteroides.
    9. Porcentaje de pacientes que discontinúan el uso de corticosteroides después de la incorporación al estudio.
    10. Reducción porcentual de la dosis diaria media (o equivalente) de inhibidores de la calcineurina.
    11. Porcentaje de pacientes que discontinúan el uso de inhibidores de la calcineurina después de la incorporación al estudio.

    Seguridad:
    1. Frecuencia e intensidad de los acontecimientos adversos (AA) y los acontecimientos adversos graves (AAG).
    2. Variación respecto al periodo basal en los valores de las constantes vitales, los parámetros analíticos de seguridad, la exploración física y neurológica, el ECG y la escala del estado funcional de Karnofsky/Lansky.
    3. Variación respecto al periodo basal en los marcadores del recambio óseo.
    4. Variación respecto al periodo basal en la densidad ósea.

    Farmacodinámica (FC)
    1. Parámetros FC de axatilimab y factores de los pacientes que pueden explicar la variabilidad en la exposición al fármaco.
    2. Variación respecto al periodo basal en los niveles del factor estimulante de colonias 1 (CSF-1) y la interleucina 34 (IL-34), y su asociación con la respuesta de la EICHc.
    3. Variación respecto al periodo basal en el número de monocitos circulantes y su fenotipo (CD14/16).
    4. Número basal de monocitos circulantes y su fenotipo (CD14/16).

    Inmunogenicidad:
    1.Presencia de anticuerpos antifármaco (AAF).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy:
    1-11. Throughout the study

    Safety:
    1-4. Throughout the study

    Pharmacodynamics:
    1-4. Throughout the study

    Immunogenicity:
    1. Day 1 up to Cycle 12, EOT and follow-up visit.
    Eficacia:
    1-11. Durante todo el estudio

    Seguridad:
    1-4. Durante todo el estudio

    Farmacodinámica:
    1-4. Durante todo el estudio

    Inmunogenicidad:
    1. Día 1 hasta el Ciclo 12, FdT y visita de seguimiento.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic 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.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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA30
    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
    Australia
    Canada
    Korea, Republic of
    Singapore
    United States
    Belgium
    France
    Germany
    Italy
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Patient Last Visit (LPLV)
    Última visita del último paciente (UVUP)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 42
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 17
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 25
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 116
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 52
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 66
    F.4.2.2In the whole clinical trial 210
    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)
    At the completion of the trial, the patient will be supported onto standard of care.
    Una vez finalizado el ensayo, el paciente pasará a recibir el tratamiento estándar.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-09
    P. End of Trial
    P.End of Trial StatusOngoing
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