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    Summary
    EudraCT Number:2020-006104-17
    Sponsor's Protocol Code Number:CDFV890B12201
    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:2021-06-23
    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 number2020-006104-17
    A.3Full title of the trial
    A randomized, two-arm, placebo-controlled, participant and investigator-blinded study investigating the efficacy, safety and tolerability of DFV890 in patients with symptomatic knee osteoarthritis
    Estudio aleatorizado, doble ciego (participante e investigador), de dos grupos y controlado con placebo en el que se investiga la eficacia, la seguridad y la tolerabilidad de DFV890 en pacientes con osteoartritis de rodilla sintomática.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy, safety and tolerability of DFV890 in patients with knee osteoarthritis
    Estudio de la eficacia, la seguridad y la tolerabilidad de DFV890 en pacientes con osteoartritis de rodilla.
    A.4.1Sponsor's protocol code numberCDFV890B12201
    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 SponsorNovartis Farmacéutica S.A.
    B.1.3.4CountrySpain
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMo)
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34900353036
    B.5.5Fax number+34932479903
    B.5.6E-maileecc.novartis@novartis.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 nameDFV890
    D.3.2Product code DFV890
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot yet established
    D.3.9.3Other descriptive nameDFV890
    D.3.9.4EV Substance CodeSUB208521
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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.IMP: 2
    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 nameDFV890
    D.3.2Product code DFV890
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot yet established
    D.3.9.3Other descriptive nameDFV890
    D.3.9.4EV Substance CodeSUB208521
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    knee osteoarthritis
    osteoartritis de rodilla
    E.1.1.1Medical condition in easily understood language
    knee osteoarthritis
    osteoartritis de rodilla
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee osteoarthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of oral DFV890 vs. placebo in participants with knee OA for relieving OA pain
    Determinar la eficacia de DFV890 oral frente a placebo en participantes con OA de rodilla para aliviar el dolor OA
    E.2.2Secondary objectives of the trial
    1) To assess the efficacy of DFV890 vs. placebo in participants with knee OA on inflammatory joint structure features
    2) To assess the safety and tolerability of DFV890 vs. placebo
    3) To assess the effect of DFV890 compared to placebo on systemic inflammatory status
    4) To assess pharmacokinetics of DFV890 in plasma
    5) To assess the efficacy of DFV890 vs. placebo in improving participants' report of knee symptoms and associated problems over time
    6) To assess the efficacy of DFV890 vs. placebo in relieving OA pain over time
    1) Evaluar la eficacia del tratamiento con DFV890 frente a placebo en participantes con OA de rodilla en las características de las estructuras articulatorias inflamatorias
    2) Evaluar la seguridad y tolerabilidad de DFV890 frente a placebo
    3) Evaluar el cambio en los marcadores inflamatorios sistémicos cuando se tratan con DFV890 frente a placebo
    4) Evaluar la farmacocinética en plasma de DFV890
    5) Evaluar los cambios en los síntomas de la rodilla y los parámetros asociados cuando se tratan con DFV890 frente a placebo
    6) Evaluar la eficacia de DFV890 frente a placebo para aliviar el dolor de la OA a lo largo del tiempo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    • Male and female participants >= 50 and <= 80 years old on the day of Informed Consent signature.
    • Participants must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 35 kg/m2 at screening. BMI = Body weight (kg) / [Height (m)]2 • High sensitivity C-reactive protein (hsCRP) >=2 mg/L at screening • Symptomatic OA with pain (Numeric Rating Scale [NRS] 5-9, inclusive) in the target knee for the majority of days in the last 3 months prior to screening • KOOS pain sub-scale score <= 60 in index knee at screening and baseline • Radiographic disease: K&L grade 2 or 3 knee osteoarthritis and joint space width 2-4 mm for males and 1.5-3.5 mm for females in the medial tibiofemoral compartment (TFC) in the target knee • Active synovial inflammation at screening, defined as either moderate (score 9-12) or severe (score >=13) based on contrast enhanced MRI (CE-MRI) of the whole knee for synovitis detection from 11 sites

    Please refer to protocol section 5.1 for an exhaustive list of inclusion criteria
    Criterios de inclusión principales:
    • Participantes de ambos sexos >=50 y <=80 años el día de la firma del consentimiento informado.
    • Los participantes deben pesar al menos 50 kg para participar en el estudio y deben tener un índice de masa corporal (IMC) entre 18 y 35 kg/m2 en la selección. IMC = peso corporal (kg)/[estatura (m)]2. • Proteína C reactiva de alta sensibilidad (hsCPR) >=2 mg/l en la selección.•OA sintomática con dolor (escala numérica 5-9, inclusive) en la rodilla evaluada la mayoría de días en los 3 meses anteriores a la selección.
    • Puntuación en la subescala del dolor KOOS <=60 en la rodilla de referencia en la selección y la basal.• Enfermedad radiográfica: Osteoartritis de rodilla con puntuación de K&L grado 2 o 3 y anchura del espacio articular de 2-4 mm para hombres y de 1,5-3,5 mm para mujeres en el compartimento tibiofemoral (CTF) medial de la rodilla evaluada . • Inflamación sinovial activa en la selección, definida como moderada (puntuación 9-12) o grave (puntuación >=13) basada en RM realzada por contraste (RM-C) de toda la rodilla para detectar la sinovitis en 11 puntos.

    Por favor, dirigirse a la sección 5.1 del protocolo para un listado detallado de los criterios de inclusión
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    • Total WBC count < 3,000/µL, absolute peripheral blood neutrophil count (ANC) < 1,000/µL, hemoglobin < 8.5 g/dL (85 g/L) or platelet count < 100,000/µL at Screening • Known autoimmune disease with inflammatory arthritis (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus), crystal-induced arthritis (gout, pseudogout associated arthritis), active acute or chronic infection or past infection of the knee joint, Lyme disease involving the knee, reactive arthritis, systemic cartilage disorders, moderate to severe fibromyalgia (widespread pain index, WPI, >4 out of 19), or a known systemic connective tissue disease • Any known active infections, including skin or knee infections or infections that may compromise the immune system, such as HIV or chronic hepatitis B or C infection • Use of prohibited medications: any local i.e. treatment into the knee, including but not restricted to viscosupplementation and corticosteroids within 12 weeks prior to Day 1; long-term treatment (>14 days) with oral corticosteroids >5 mg/day within 4 weeks prior to Day 1; oral glucosamine, chondroitin sulfate, or any nutraceutical with potential activity on cartilage repair within 2 weeks prior to Day 1; systemic Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or selective COX-2 inhibitors within 5 half-lives from PRO assessments; any other immunomodulatory drugs or treatment which cannot be discontinued or switched to a different medication within 28 days or 5 half-lives of screening (whichever is longer if required by local regulations), or until the expected PD effect has returned to baseline.
    • Contralateral knee pain >=4 by NRS for the majority of days in the last 3 months prior to Screening • Participants with the CYP2C9 *3/*3 genotype defined as homozygous carriers of the CYP2C9*3 allele.
    • Severe malalignment greater than 7.5 degrees in the target knee (either varus or valgus), measured using x-ray at Screening


    Please refer to protocol section 5.2 for an exhaustive list of exclusion criteria
    Criterios de exclusión principales:
    • Recuento de leucocitos total <3000/μl, recuento absoluto de neutrófilos (RAN) en sangre periférica <1000/μl, hemoglobina <8,5 g/dl (85 g/l) o recuento de plaquetas <100 000/μl en la selección.
    • Enfermedad autoinmune conocida con artritis inflamatorias (incluyendo, entre otras, artritis reumatoide, artritis psoriásica, espondilitis anquilosante o lupus eritematoso sistémico), artritis inducidas por cristales (gota, seudogota asociada a artritis), infección aguda o crónica activa o infección anterior de la articulación de la rodilla, enfermedad de Lyme en la rodilla, artritis reactiva, trastornos sistémicos del cartílago, fibromialgia de moderada a grave (Widespread Pain Index, WPI), >4 de 19) o una enfermedad sistémica conocida del tejido conjuntivo.
    • Cualquier infección activa conocida, incluyendo infecciones de la piel o la rodilla o infecciones que puedan afectar al sistema inmunitario, como VIH o infección crónica por hepatitis B o C.
    • Uso de medicación prohibida: cualquier tratamiento local en la rodilla, incluyendo, entre otros, viscosuplementación y corticosteroides en las 12 semanas anteriores al día 1; tratamiento a largo plazo (>14 días) con corticosteroides orales >5 mg/día durante las 4 semanas anteriores al día 1; glucosamina oral, sulfato de condroitín o cualquier nutracéutico con actividad potencial en la reparación del cartílago durante las 2 semanas anteriores al día 1; fármacos antiinflamatorios no esteroideos sistémicos (AINE) o inhibidores de la COX-2 selectivos durante las 5 vidas medias desde las evaluaciones de resultados reportados por el paciente (PRO); cualquier otro fármaco o tratamiento inmunomodulador que no se pueda discontinuar o cambiar a otra medicación durante los 28 días o 5 vidas medias anteriores a la selección (aquel periodo que sea más largo si lo requiere la normativa local) o hasta que el efecto farmacodinámico (PD) esperado haya vuelto al valor basal.
    • Dolor en la rodilla contralateral >=4 según la escala numérica durante la mayoría de días en los 3 meses anteriores a la selección.
    • Participantes con el genotipo CYP2C9 *3/*3 definido como portadores homocigóticos del alelo CYP2C9*3.
    • Desalineación grave superior a 7,5 grados en la rodilla evaluada (varo o valgo) medido por radiografía en la selección.

    Por favor, dirigirse a la sección 5.2 del protocolo para un listado detallado de los criterios de inclusión
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in Knee injury and Osteoarthritis Outcome Score (KOOS) pain sub-scale at week 12 Time Frame: Baseline to Week 12
    cambio desde la basal hasta la semana 12 en la subescala del dolor Knee injury and Osteoarthritis Outcome Score (KOOS). Periodo de tiempo: visita Basal a Semana 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time Frame: Baseline to Week 12
    Periodo de tiempo: visita Basal a Semana 12
    E.5.2Secondary end point(s)
    1) Change from baseline in synovitis activity level measured from Ktrans by DCE-MRI at week 12
    2) Systemic and local AEs and SAEs, ECGs parameters, Vital signs, Hematology, blood chemistry and urinalysis Time Frame: Up to the end of study
    3) Change from baseline in serum high sensitivity C-reactive protein level and absolute neutrophil counts at week 2,4,8 and 12 Time Frame: Baseline to Week 12
    4) Plasma samples to quantify concentrations of DFV890 at various time points (week 2 and week 12) and to derive PK parameters in plasma (including but not limited to Cmax, AUC last, AUC0-12h, and Cthrough) Time Frame: Week 2, Week 12
    5) Change from baseline in KOOS sub-scales (other symptoms, function in daily living, function in sport and recreation, knee-related quality of life) at weeks 2, 4, 8 and 12 Time Frame: Week 2, Week 4, Week 8, Week 12
    6) Outcome Measure: Change in KOOS pain subscale and NRS for pain from baseline to weeks 2, 4, 8 and 12 Time Frame: Baseline to Week 2, 4, 8 and 12
    1) Cambio respecto a la basal en el nivel de actividad de la sinovitis medido por la Ktrans de la resonancia magnética (RM) en la semana 12.
    2) Acontecimientos adversos y acontecimientos adversos graves sistémicos y locales; electrocardiogramas; constantes vitales; hematología, análisis bioquímico de sangre y análisis de orina.
    3) cambio en los marcadores inflamatorios sistémicos (proteína C reactiva ultrasensible en suero y recuento absoluto de neutrófilos), cuando se tratan con DFV890 frente a placebo tras 2, 4, 8 y 12 semanas de tratamiento. Periodo de tiempo: visita Basal a Semana 12
    4) Muestras de plasma para cuantificar las concentraciones de DFV890 en diferentes puntos de tiempo (semana 2 y semana 12) y para derivar parámetros PK en plasma (que incluyen, entre otros, Cmax, AUC al final, AUC0-12h y Cthrough). Periodo de tiempo: Semana 2 y Semana 12
    5)Evaluar los cambios en los síntomas de la rodilla y los parámetros asociados cuando se tratan con DFV890 frente a placebo tras 2, 4, 8 y 12 semanas de tratamiento basándose en las subescalas KOOS incluyendo otros síntomas, función en la vida diaria, función en deporte y ocio y calidad de vida relacionada con la rodilla.
    6) Medida de resultado: cambio en la subescala del dolor KOOS desde la basal hasta las semanas 2, 4, 8 y 12 y en el cambio en la escala numérica del dolor desde la basal hasta las semanas 2, 4, 8 y 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Time Frame: Baseline to Week 12
    2) Time Frame: Up to the end of study
    3) Time Frame: Baseline to Week 2, 4, 8 and 12
    4) Time Frame: Week 2, Week 12
    5) Time Frame: Week 2, Week 4, Week 8, Week 12
    6) Time Frame: Baseline to Week 2, 4, 8 and 12
    1) Periodo de tiempo: visita Basal a Semana 12
    2) Periodo de tiempo: hasta el Final del ensayo
    3) Periodo de tiempo: visita Basal hasta la Semana 2, 4, 8 y 12
    4) Periodo de tiempo: Semana 2 y Semana 12
    5) Periodo de tiempo: Semana 2, Semana 4, Semana 8, Semana 12
    6) Periodo de tiempo: visita basal a Semana 2, 4, 8 y 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic 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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Russian Federation
    United States
    Germany
    Hungary
    Slovakia
    Spain
    Czechia
    Argentina
    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
    Study completion is defined as when the last participant finishes their Study Completion visit and any repeat assessments associated with this visit have been documented and followed-up appropriately by the Investigator or, in the event of an early study termination decision, the date of that decision.
    La finalización del estudio queda definida cuando el último participante finaliza su visita de finalización del estudio y el investigador ha documentado y realizado un seguimiento adecuado de cualquier evaluación repetida asociada con esta visita o, en el caso de una decisión de finalización anticipada del estudio, la fecha de dicha decisión
    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 months1
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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 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: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 80
    F.4.2.2In the whole clinical trial 108
    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)
    Continuing care should be provided by the investigator and/or referring physician. No further study treatment will be provided.
    El investigador y / o el médico que refiere al paciente deben brindar atención continua. No se proporcionará ningún tratamiento de estudio adicional
    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 Decision2021-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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