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    Summary
    EudraCT Number:2017-003723-29
    Sponsor's Protocol Code Number:JBT101-CF-002
    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:2018-04-09
    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 number2017-003723-29
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
    Ensayo en fase II multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y seguridad del lenabasum en la fibrosis quística
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of safety and efficacy of lenabasum in Cystic Fibrosis
    Un estudio de seguridad y eficacia del Lenabasum en la fibrosis quística
    A.3.2Name or abbreviated title of the trial where available
    A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis
    Estudio Fase 2 de seguridad y eficacia de Lenabasum en la Fibrosis Quísia
    A.4.1Sponsor's protocol code numberJBT101-CF-002
    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 SponsorCorbus 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 supportCorbus Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeon Research SL
    B.5.2Functional name of contact pointRegulatory Affairs Department
    B.5.3 Address:
    B.5.3.1Street AddressAvd. Ordoño II, Nº 37-2ºDcha
    B.5.3.2Town/ cityLeón
    B.5.3.3Post code24001
    B.5.3.4CountrySpain
    B.5.4Telephone number+34987261064
    B.5.5Fax number+34987216243
    B.5.6E-mailiminguez@leonresearch.es
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1736
    D.3 Description of the IMP
    D.3.1Product nameLenabasum
    D.3.2Product code JBT-101
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLenabasum
    D.3.9.1CAS number 137945-48-3
    D.3.9.2Current sponsor codeJBT-101
    D.3.9.3Other descriptive nameresunab, ajulemic acid, anabasum
    D.3.9.4EV Substance CodeSUB178399
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1736
    D.3 Description of the IMP
    D.3.1Product nameLenabasum
    D.3.2Product code JBT-101
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLenabasum
    D.3.9.1CAS number 137945-48-3
    D.3.9.2Current sponsor codeJBT-101
    D.3.9.3Other descriptive nameresunab, ajulemic acid, anabasum
    D.3.9.4EV Substance CodeSUB178399
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboCapsule, hard
    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
    Cystic Fibrosis (CF)
    Fibrosis quística
    E.1.1.1Medical condition in easily understood language
    Cystic Fibrosis is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
    Fibrosis quística es un trastorno genético que produce moco espeso en las vías respiratorias con aumento de las infecciones y fibrosis en pulmones, en el tracto digestivo y una función inmune anormal.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of lenabasum 20 mg twice per day (BID) compared to placebo in the treatment of cystic fibrosis (CF) by assessing the rate of pulmonary exacerbations (PEx) using primary definition of PEx
    Evaluar la eficacia de lenabasum 20 mg administrado dos veces al día (2 v/d) respecto del placebo en el tratamiento de la fibrosis quística (FQ) mediante evaluación de la tasa de exacerbaciones pulmonares (ExP) utilizando la definición principal de ExP
    E.2.2Secondary objectives of the trial
    Efficacy:
    1. To evaluate the efficacy of lenabasum 20 mg BID compared to placebo in the treatment of CF by assessing other efficacy endpoints
    2. To evaluate the efficacy of lenabasum 5 mg BID compared to placebo in the treatment of CF
    Pharmacokinetic:
    1. To evaluate steady state plasma concentrations of lenabasum 20 mg and 5 mg BID at the estimated time of trough concentration after a dose of lenabasum
    2. To evaluate plasma concentrations of lenabasum 20 mg and 5 mg at the estimated time of peak concentration after the first dose
    3. To evaluate metabolites of lenabasum
    4. To develop population pharmacokinetic models of lenabasum exposure in CF subjects
    Safety:
    1. To evaluate safety of lenabasum 20 mg BID and lenabasum 5 mg BID treatment and placebo treatment
    2. To evaluate tolerability of lenabasum 20 mg BID and lenabasum 5 mg BID treatment
    Eficacia:
    1.Evaluar la eficacia de lenabasum 20 mg 2 v/d respecto del placebo para el tratamiento de la FQ mediante evaluación de otros criterios de valoración de la eficacia.
    2.Evaluar la eficacia de lenabasum 5 mg 2 v/d respecto del placebo para el tratamiento de la FQ
    Farmacocinética:
    1.Evaluar las concentraciones en plasma en estado estacionario de lenabasum 20 mg 2 v/d y lenabasum 5 mg 2 v/d en el tiempo estimado de concentración mínima tras una dosis de lenabasum.
    2.Evaluar las concentraciones en plasma de lenabasum 20 mg y 5 mg en el tiempo estimado de concentración máxima tras la primera dosis.
    3.Evaluar los metabolitos de lenabasum.
    4.Desarrollar modelos de población farmacocinética de exposición al lenabasum en sujetos con FQ.
    Seguridad:
    1.Evaluar la seguridad del tratamiento con lenabasum 20 mg 2 v/d y lenabasum 5 mg 2 v/d y del tratamiento con placebo.
    2.Evaluar la tolerabilidad del tratamiento con lenabasum 20 mg 2 v/d y con lenabasum 5 mg 2 v/d.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Documentation of a CF diagnosis as evidenced by 1 or more clinical features consistent with the CF phenotype and 1 or more of the following criteria:
    a. Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test
    b. Two known disease-causing mutations in the CFTR gene.
    2. Twelve years of age or older at the time Informed Consent/Assent is signed.
    3. Weight ≥ 40 kg.
    4. FEV1 ≥ 40% predicted and < 100 % predicted within the last 12 months.
    5. Physician-initiated treatment with an IV antibiotic 2 or 3 times in the last 12 months for a new PEx.
    6. As an alternative to inclusion criterion 5, physician-initiated treatment with an IV antibiotic 1 time in the last 12 months plus physician-initiated treatment with oral antibiotic(s) 1 or more times in the past 12 months for a new PEx.
    7. Completion of the last course of antibiotics prescribed for any PEx ≥ 28 days before Visit 1.
    8. Able to perform pulmonary function tests. Optional use of a bronchodilator before testing is allowed to facilitate testing if the bronchodilator is used consistently starting with Visit 1.
    9. Willing to provide repeat sputum specimens. If a subject is unable to reliably spontaneously expectorate sputum, induced sputum collection is acceptable. Optional collection of induced sputum specimens is allowed if induced sputum specimens are consistently collected starting with Visit 1. Adolescents should try to produce sputum spontaneously and can opt out of sputum induction.
    10. Willing not to use any cannabinoids or any illegal substance of abuse from screening through Visit 9.
    11. Women of childbearing potential must not be pregnant or breastfeeding at Visit 1 and must be using at least one highly effective method of contraception (failure rate < 1% per year) for at least 28 days before Visit 1 and be willing to continue to use at least one highly effective method of contraception throughout the study and for at least 28 days after discontinuation of study drug .
    12. Able to adhere to the study visit schedule and other protocol requirements.
    1.Documentación de un diagnóstico de FQ como se evidencia por una o más características clínicas consistentes con el fenotipo de FQ y uno o más de los siguientes criterios:
    a.Cloruro de sudor ≥60 mEq / l mediante prueba cuantitativa de iontoforesis con pilocarpina
    b.Dos mutaciones conocidas que causan enfermedades en el gen CFTR.
    2. 12 años o más en el momento en que se firma el consentimiento informado.
    3. Peso ≥ 40 kg.
    4. FEV1 ≥ 40% pronosticado y <100% pronosticado en los últimos 12 meses.
    5. Tratamiento iniciado por un médico con un antibiótico IV 2 o 3 veces en los últimos 12 meses para un nuevo ExP.
    6. Como alternativa al criterio de inclusión 5, tratamiento iniciado por un médico con un antibiótico IV 1 vez en los últimos 12 meses más tratamiento iniciado por un médico con antibiótico oral 1 o más veces en los últimos 12 meses para un nuevo ExP
    7. Finalización del último ciclo de antibióticos recetados para cualquier ExP ≥ 28 días antes de la Visita 1.
    8. Capaz de realizar pruebas de función pulmonar. Se permite el uso opcional de un broncodilatador antes de la prueba para facilitar las pruebas si el broncodilatador se usa de manera consistente comenzando con la visita 1.
    9. Dispuesto a proporcionar muestras repetidas de esputo. Si un sujeto no puede expectorar el esputo de forma espontánea y confiable, la recolección inducida de esputo es aceptable. Se permite la recolección opcional de muestras de esputo inducido si las muestras de esputo inducido se recolectan consistentemente a partir de la Visita 1. Los adolescentes deben tratar de producir esputo espontáneamente y pueden optar por la inducción del esputo.
    10. Dispuesto a no usar ningún cannabinoide o sustancia ilegal de abuso de la detección a través de la Visita 9.
    11. Las mujeres en edad fértil no deben estar embarazadas o amamantando en la visita 1 y deben usar al menos un método anticonceptivo altamente eficaz (tasa de fracaso <1% por año) durante al menos 28 días antes de la visita 1 y estar dispuestos a continuar a utilizar al menos un método anticonceptivo altamente eficaz durante todo el estudio y durante al menos 28 días después de la interrupción del medicamento del estudio.
    12. Capaz de cumplir con el cronograma de visitas de estudio y otros requisitos de protocolo.
    E.4Principal exclusion criteria
    1. Severe or unstable CF at screening or Visit 1, such as:
    a. Change in dose, or initiation of any new chronic therapy for CF lung disease within 28 days before Visit 1
    b. Treatment with any systemic corticosteroids > 10 mg per day prednisone or equivalent within 14 days before Visit 1
    c. Actively listed on an organ transplant list or have had an organ transplant other than corneal transplant.
    2. Significant diseases or conditions other than CF that may influence response to the study drug or safety, such as:
    a. Active hepatitis B or C infection
    b. Human immunodeficiency virus infection
    c. A history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≥ one year before Visit 1.
    3. Pregnant, trying to become pregnant or lactating female.
    4. Current evidence of alcohol abuse (defined as 4 or more drinks per day on at least 4 days of the week) or history of abuse of illegal and/or legally prescribed drugs such as barbiturates, benzodiazepines, amphetamines, cocaine, or opioids during the 1 year before screening.
    5. Any investigational agent within 30 days or five therapeutic half-lives of that agent whichever is longer, before Visit 1
    6. Any of the following values for laboratory tests at screening:
    a. A positive pregnancy test
    b. Hemoglobin < 10 g/dL in males and < 9 g/dL in females.
    c. Neutrophils < 1.0 x 1000,000,000/L
    d. Platelets < 75 x 1000,000,000/L
    e. Creatinine clearance < 50 ml/min according to Modification of Diet in Renal Disease (MDRD) Study equation
    f. Serum transaminases > 2.5 x upper normal limit
    7. Any other condition or concurrent medical therapy at screening or Visit 1 that causes the investigator to determine it is not safe for the subject to participate or that may influence response to study drug or interfere with study assessments.
    1. FQ severa o inestable en el cribado o visita 1, como:
    a. Cambio en la dosis o inicio de cualquier nueva terapia crónica para la enfermedad pulmonar de la FQ dentro de los 28 días anteriores a la Visita 1
    b. Tratamiento con cualquier corticosteroide sistémico> 10 mg por día de prednisona o equivalente dentro de los 14 días previos a la Visita 1
    c Enumerado activamente en una lista de trasplante de órganos o ha tenido un trasplante de órgano diferente al trasplante de córnea.
    2. Enfermedades o afecciones importantes distintas de la FQ que pueden influir en la respuesta al fármaco o la seguridad del estudio, como por ejemplo:
    a. Infección activa por hepatitis B o C
    b. Infección por el virus de la inmunodeficiencia humana
    c. Antecedentes de cáncer, excepto carcinoma de células basales o carcinoma in situ de cuello uterino tratado con éxito aparente con terapia curativa ≥ un año antes de la visita 1.
    3. Embarazada, tratando de quedar embarazada o mujer lactante.
    4. Evidencia actual de abuso de alcohol (definido como 4 o más bebidas por día en al menos 4 días de la semana) o antecedentes de abuso de drogas ilegales y / o prescritas legalmente, como barbitúricos, benzodiazepinas, anfetaminas, cocaína u opioides durante el 1 año antes de la proyección.
    5. Cualquier agente de investigación dentro de los 30 días o cinco semividas terapéuticas de ese agente, lo que sea mayor, antes de la Visita 1
    6. Cualquiera de los siguientes valores para pruebas de laboratorio en el cribado:
    a. Una prueba de embarazo positiva
    b. Hemoglobina <10 g / dL en hombres y <9 g / dL en mujeres.
    c. Neutrófilos <1.0 x 1000,000,000 / L
    d. Plaquetas <75 x 1000,000,000 / L
    e. Depuración de creatinina <50 ml / min según la ecuación del estudio Modificación de la dieta en la enfermedad renal (MDRD)
    f. Transaminasas séricas> 2.5 x límite superior normal
    7. Cualquier otra condición o terapia médica concurrente en el examen o la Visita 1 que haga que el investigador determine que no es seguro que el sujeto participe o que pueda influir en la respuesta al medicamento del estudio o que interfiera con las evaluaciones del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of PEx using primary definition of PEx with lenabasum 20 mg BID, compared to placebo, during the treatment period
    Tasa de exacerbaciones pulmonares (ExP) utilizando la definición principal de ExP con lenabasum 20 mg 2 v/d respecto del placebo durante el periodo de tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 1 through study completion, up to 6 months
    Visita 1 hasta completar el estudio, hasta los 6 meses
    E.5.2Secondary end point(s)
    Efficacy (lenabasum 20 mg BID):
    a. Event rate of PEx using secondary definition of PEx with lenabasum 20 mg BID compared to placebo
    b. Time to first new PEx using primary definition of PEx with lenabasum 20 mg BID compared to placebo
    c. Time to first PEx using secondary definition of PEx with lenabasum 20 mg BID compared to placebo
    d. Change from baseline in CFQ-R respiratory symptom domain with lenabasum 20 mg BID compared to placebo
    e. Change from baseline in FEV1 % predicted with lenabasum 20 mg BID compared to placebo
    Efficacy (lenabasum 5 mg BID):
    a. Rate of pulmonary exacerbations (PEx) using primary definition of PEx with lenabasum 5 mg BID compared to placebo, during the treatment period
    b. Event rate of PEx using secondary definition of PEx with lenabasum 5 mg BID compared to placebo
    c. Time to first new PEx using primary definition of PEx with lenabasum 5 mg BID compared to placebo
    d. Time to first PEx using secondary definition of PEx with lenabasum 5 mg BID compared to placebo
    e. Change from baseline in CFQ-R respiratory symptom domain with lenabasum 5 mg BID compared to placebo
    f. Change from baseline in FEV1 % predicted with lenabasum 5 mg BID compared to placebo
    Pharmacokinetics:
    1. Estimated trough plasma concentrations of lenabasum
    2. Estimated maximum plasma concentration (Cmax) of lenabasum
    3. Metabolites of lenabasum
    Safety:
    1. Treatment emergent adverse events (TEAEs)
    2. Changes in vital signs, physical examination, blood and urine laboratory safety tests and electrocardiograms
    3. Treatment discontinuations with lenabasum treatments compared to placebo
    Eficacia (lenabasum 20 mg BID):
    a. Tasa de eventos de PEx usando la definición secundaria de PEx con lenabasum 20 mg BID en comparación con placebo
    b. Tiempo hasta la primera nueva PEx usando la definición primaria de PEx con lenabasum 20 mg BID en comparación con placebo.
    c. Tiempo hasta la primera PEx usando la definición secundaria de PEx con lenabasum 20 mg BID en comparación con placebo.
    d. Cambio desde el inicio en el dominio de síntomas respiratorios CFQ-R con lenabasum 20 mg BID en comparación con placebo
    e. Cambio desde el valor inicial en FEV1% previsto con lenabasum 20 mg BID en comparación con placebo
    Eficacia (lenabasum 5 mg BID):
    a. Tasa de exacerbaciones pulmonares (PEx) usando la definición primaria de PEx con lenabasum 5 mg BID en comparación con placebo, durante el período de tratamiento
    b. Tasa de evento de PEx usando la definición secundaria de PEx con lenabasum 5 mg BID en comparación con placebo
    c. Tiempo hasta la primera nueva PEx usando la definición primaria de PEx con lenabasum 5 mg BID en comparación con placebo
    d. Tiempo hasta la primera PEx usando la definición secundaria de PEx con lenabasum 5 mg BID en comparación con placebo
    e. Cambio desde el inicio en el dominio de síntomas respiratorios CFQ-R con 5 mg de BID de lenabasum en comparación con placebo
    f. Cambio desde el valor inicial en FEV1% predicho con lenabasum 5 mg BID en comparación con placebo
    Farmacocinética:
    1. Estimación de las concentraciones plasmáticas mínimas de lenabasum
    2. Concentración máxima estimada de plasma (Cmax) de lenabasum
    3. Metabolitos de lenabasum
    Seguridad:
    1. Eventos adversos emergentes del tratamiento (TEAEs)
    2. Cambios en los signos vitales, el examen físico, las pruebas de seguridad del laboratorio de sangre y orina y los electrocardiogramas
    3. Interrupciones del tratamiento con tratamientos con lenabasum en comparación con placebo
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy and Safety endpoints: Visit 1 through study completions, up to 6 months;
    PK endpoints: Visit 1 through Visit 8.
    Puntos finales de eficacia y seguridad: visita 1 hasta completar el estudio, hasta 6 meses;
    PK extremos: visita 1 a visita 8.
    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 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.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 trial3
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA68
    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
    Austria
    Belgium
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Greece
    Italy
    Netherlands
    Poland
    Réunion
    Romania
    Russian Federation
    Serbia
    Slovakia
    Spain
    United Kingdom
    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
    LVLS
    UVUP (Ultima visita ultimo paciente)
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 62
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 62
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 353
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    For subjects that are under age and incapable of giving consent personally, as per local regulation, parental consent, consent and assent will be conducted per age group, as required by local regulation
    Pacientes menores de edad e incapaces de dar su consentimiento personalmente, según la regulación local, el consentimiento de los padres, el consentimiento y el asentimiento se llevarán a cabo por grupo de edad, según lo exige la regulación local
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 415
    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)
    After the trial, subjects will continue to receive care for cystic fibrosis from their treating physician. Subjects will remain on their baseline treatment for cystic fibrosis during the trial to reduce the risk of disease flare where study product is discontinued.
    Después del ensayo, los pacientes seguirán recibiendo atención para la fibrosis quística por el médico que le trata. Los pacientes permanecerán en su tratamiento inicial para la fibrosis quística durante el ensayo para reducir el riesgo de brote de la enfermedad cuando suspenda el producto del estudio.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation European Cystic Fibrosis Society (ECFS) - Clinical Trial Network
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-25
    P. End of Trial
    P.End of Trial StatusOngoing
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