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    Summary
    EudraCT Number:2015-003289-97
    Sponsor's Protocol Code Number:I8K-MC-JPDA
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-02-21
    Trial results View 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 number2015-003289-97
    A.3Full title of the trial
    Protocol I8K-MC-JPDA(c)
    A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study
    Protocolo I8K-MC-JPDA(c)
    Estudio de fase 2, aleatorizado, con enmascaramiento doble, comparativo con placebo, con 2 partes, en el que se evalúan la seguridad y la eficacia de LY3337641 en pacientes adultos con artritis reumatoide: Estudio RAjuvenate
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis
    Estudio para determinar la seguridad y la eficacia de LY3337641 en pacientes adultos con artritis reumatoide
    A.3.2Name or abbreviated title of the trial where available
    The RAjuvenate Study
    Estudio RAjuvenate
    A.4.1Sponsor's protocol code numberI8K-MC-JPDA
    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 SponsorLilly 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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLilly S.A.
    B.5.2Functional name of contact pointMaria Pilar Lopez
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de la Industria 30
    B.5.3.2Town/ cityAlcobendas (Madrid)
    B.5.3.3Post code28108
    B.5.3.4CountrySpain
    B.5.4Telephone number0034916231218
    B.5.5Fax number0034916633481
    B.5.6E-mailensayosclinicos@lilly.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 nameLY3337641 5 mg
    D.3.2Product code LY3337641
    D.3.4Pharmaceutical form 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 available
    D.3.9.2Current sponsor codeLY3337641
    D.3.9.4EV Substance CodeSUB179732
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLY3337641 20 mg
    D.3.2Product code LY3337641
    D.3.4Pharmaceutical form 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 available
    D.3.9.2Current sponsor codeLY3337641
    D.3.9.4EV Substance CodeSUB179732
    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 placeboTablet
    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 placeboTablet
    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
    Rheumatoid Arthritis
    Artritis reumatoide
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    Artritis reumatoide
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective 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
    Part A: To evaluate the safety and tolerability of LY3337641 at 5, 10, and 30 mg qd in subjects with RA

    Part B: To evaluate the efficacy, safety, and tolerability of LY3337641 at 10 and 30 mg qd versus placebo at Week 12 for the treatment of subjects with moderately to severely active RA
    Parte A: Evaluar la seguridad y la tolerabilidad de LY3337641 en dosis de 5, 10 y 30 mg, 1 v/día, en pacientes con AR

    Parte B: Comparar la eficacia, la seguridad y la tolerabilidad de LY3337641 (dosis de 10 y 30 mg, administradas 1 v/d) con el placebo en la semana 12 en el tratamiento de pacientes con AR activa entre moderada e intensa.
    E.2.2Secondary objectives of the trial
    Part A: N/A
    Part B:
    • To evaluate the efficacy of LY3337641 at 5, 10 and 30 mg qd versus placebo at Week 12 on RA clinical endpoints
    • To characterize the PK of LY3337641 in subjects with RA
    Parte A: No corresponde
    Parte B:
    • Comparar la eficacia de LY3337641 (dosis de 5, 10 y 30 mg, administradas 1 v/d) con el placebo en la semana 12 en lo que respecta a los criterios clínicos de valoración de la AR.
    • Caracterizar la FC de LY3337641 en pacientes con AR.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Female subjects: test negative for pregnancy at screening and agree not to breastfeed
    • Female subjects: agree to use a reliable method of birth control from the start of screening until 2 weeks after the last dose of study drug or be of nonchildbearing potential:
    o are postmenopausal
    o have undergone bilateral tubal ligation, bilateral oophorectomy, and/or hysterectomy
    o have another medical cause of female infertility
    • Male subjects: agree to use a reliable method of birth control from the start of screening until 2 weeks after the last dose of study drug or have undergone vasectomy at least 6 weeks prior to screening
    • Have a diagnosis of RA based on the 2010 ACR/European League against Rheumatism criteria
    • Have at least 1 of the following:
    o rheumatoid factor or anti-citrullinated peptide antibodies (ACPA) at screening OR
    o radiographs documenting bony erosions
    • have active RA, defined as:
    o Part A: ≥3 swollen joints (based on 66-joint counts)
    o Part B:
    o ≥6 swollen joints (based on 66-joint counts)
    o ≥6 tender joints (based on 68-joint counts)
    o hsCRP greater than the upper limit of normal (ULN) OR positive for ACPA
    • Part B only: have had inadequate response, loss of response, or intolerance to at least 1 synthetic or biologic DMARD treatment for RA, regardless of treatment duration
    • Mujeres: Presentar un resultado negativo en una prueba de embarazo que se realizará durante la selección y estar de acuerdo en no dar el pecho.
    • Mujeres: Estar de acuerdo en utilizar un método anticonceptivo fiable desde el inicio de la selección hasta 2 semanas después de la última dosis del fármaco del estudio, o no ser fértil por:
    o Haber entrado en la posmenopausia.
    o Haberse sometido a una ligadura de trompas, una ovariectomía bilateral o una histerectomía.
    o Cualquier otra causa médica.
    • Varones: Estar de acuerdo en utilizar un método anticonceptivo fiable desde el inicio de la selección hasta 2 semanas después de la última dosis del fármaco del estudio o haberse sometido a una vasectomía al menos 6 semanas antes de la selección.
    • Presentar diagnóstico de AR, de acuerdo con los criterios de la ACR/European League against Rheumatism (2010).
    • Presentar al menos 1 de los siguientes criterios:
    o Factor reumatoide o anticuerpos antipéptido citrulinado (AAPC) durante la selección O
    o Erosión ósea documentada mediante radiografía.
    • Presentar AR activa, es decir:
    o Parte A: ≥ 3 articulaciones tumefactas (de un total de 66 articulaciones).
    o Parte B:
    ≥ 6 articulaciones tumefactas (de un total de 66 articulaciones).
    ≥ 6 articulaciones dolorosas a la palpación (de un total de 68 articulaciones).
    Concentración de PCRas mayor que el límite superior de la normalidad (LSN) o resultado positivo en una prueba de detección de AAPC.
    • Solo para la parte B: Presentar una respuesta insuficiente, pérdida de respuesta o intolerancia al menos a 1 tratamiento con FARME sintéticos o biológicos para la AR, independientemente de la duración de dicho tratamiento.
    E.4Principal exclusion criteria
    • Have received any of the following synthetic immunosuppressive therapies under the defined conditions:
    o methotrexate (MTX), hydroxychloroquine, sulfasalazine, or leflunomide at an UNSTABLE PRESCRIBED DOSE (defined as a change in prescription) within 28 days prior to baseline
    o concomitant treatment with MTX PLUS leflunomide within 28 days prior to baseline gold salts, kinase inhibitors (such as tofacitinib), cyclophosphamide, mycophenolic acid, azathioprine, cyclosporine, sirolimus, or tacrolimus within 28 days prior to screening
    Part B only: any prior treatment with a product directly targeting BTK (marketed or investigational)
    • Have received any of the following biologic immunosuppressive therapies:
    o etanercept, adalimumab, or anakinra within 14 days prior to baseline
    o infliximab, certolizumab pegol, golimumab, abatacept, or tocilizumab within 4 weeks prior to baseline
    o belimumab, natalizumab, or vedolizumab within 6 months prior to baseline
    o Part A only: B-cell–depleting agents (such as rituximab) or other cell-depleting biologics (eg, anti-CD3 antibody) within 12 months prior to screening
    o Part B only: B-cell–depleting agents (such as rituximab) or other cell-depleting biologics (eg, anti-CD3 antibody) at any time prior to screening
    • Have received any of the following:
    o parenteral corticosteroids within 28 days prior to baseline (A single intra-articular corticosteroid injection is permitted within 28 days prior to baseline if no more than 40 mg triamcinolone [or equivalent])
    o oral prednisone (or equivalent) >10 mg/day or UNSTABLE PRESCRIBED DOSE within 28 days prior to baseline
    o a chronic narcotic drug at an UNSTABLE PRESCRIBED DOSE within 28 days prior to baseline
    o gemfibrozil or alfentanil, dihydroergotamine, dofetilide, ergotamine, fentanyl, pimozide, or quinidine within 28 days prior to baseline
    • Have known hypogammaglobulinemia or a screening serum immunoglobulin G (IgG level) <565 mg/dL (<5.65 g/L)
    • Have hepatitis C virus (HCV) at screening. Subjects who are anti-HCVAb positive and HCV ribonucleic acid (RNA) negative can be enrolled in the study.
    • Have hepatitis B virus (HBV) at screening, defined as (1) positive for hepatitis B surface antigen OR (2) positive for anti-hepatitis B core antibody (HBcAb) AND positive for HBV DNA. Have human immunodeficiency virus antibody
    • Have active tuberculosis (TB)
    • Are at high risk of infection or have recent evidence of clinically significant infection
    • Have had lymphoma, leukemia, or any malignancy within the previous 5 years except for basal cell or squamous epithelial carcinomas of the skin
    • Have received a live (attenuated) vaccine within 28 days prior to baseline or plan to receive one during the study
    • Haber recibido cualquiera de los siguientes tratamientos inmunodepresores sintéticos según se indica a continuación:
    o Metotrexato (MTX), hidroxicloroquina, sulfasalazina o leflunomida en una DOSIS PRESCRITA INESTABLE (es decir, que la dosis prescrita se haya modificado), en el transcurso de los 28 días anteriores al período basal.
    o Sólo para la parte B: cualquier tratamiento previo con un producto dirigido directamente a BTK (comercializado o en investigación)
    o Tratamiento concomitante con MTX Y leflunomida, en el transcurso de los 28 días anteriores al período basal.
    o Sales de oro, inhibidores de la actividad cinasa (como tofacitinib), ciclofosfamida, ácido micofenólico, azatioprina, ciclosporina, sirolimús o tacrolimús, en el transcurso de los 28 días anteriores a la selección.
    • Haber recibido cualquiera de los siguientes tratamientos inmunodepresores biológicos:
    o Etanercept, adalimumab o anakinra en el transcurso de los 14 días anteriores al período basal.
    o Infliximab, certolizumab pegol, golimumab, abatacept o tocilizumab en el transcurso de las 4 semanas anteriores al período basal.
    o Belimumab, natalizumab o vedolizumab en el transcurso de los 6 meses anteriores al período basal.
    o Solo para la parte A: Fármacos que disminuyan el número de linfocitos B (como rituximab) u otros fármacos biológicos que disminuyan la cifra de células (por ejemplo, anticuerpos anti-CD3), en el transcurso de los 12 meses anteriores a la selección).
    o Solo para la parte B: Fármacos que disminuyan el número de linfocitos B (como rituximab) u otros fármacos biológicos que disminuyan la cifra de células (por ejemplo, anticuerpos anti-CD3) (en cualquier momento antes de la selección).
    • Haber recibido cualquiera de los tratamientos siguientes:
    o Corticoesteroides por vía parenteral, en el transcurso de los 28 días anteriores al período basal (se permite la administración de una única inyección intraarticular de corticoesteroides en el transcurso de los 28 días anteriores al período basal, siempre que no se administre una dosis superior a 40 mg de triamcinolona [o equivalente]).
    o Prednisona (o equivalente) por vía oral, en una dosis > 10 mg/día o UNA DOSIS PRESCRITA INESTABLE en el transcurso de los 28 días anteriores al período basal.
    o Administración prolongada de un fármaco opiáceo en una DOSIS PRESCRITA INESTABLE, en el transcurso de los 28 días anteriores al período basal.
    o Gemfibrozilo o alfentanilo, dihidroergotamina, dofetilida, ergotamina, fentanilo, pimozida o quinidina, en el transcurso de los 28 días anteriores al período basal.
    • Presentar hipogammaglobulinemia o una concentración sérica de inmunoglobulina G (concentración de IgG) < 565 mg/dl (< 5,65 g/l) en el momento de la selección.
    • Presentar el virus de la hepatitis C (VHC) en el momento de la selección. Podrán reclutarse para el estudio los pacientes que presenten un resultado positivo para el anticuerpo frente al virus de la hepatitis C (anti-HCVAb) y un resultado negativo en una prueba de detección del ácido ribonucleico (ARN) del VHC.
    • Presentar el virus de la hepatitis B (VHB) en el momento de la selección, es decir, que el paciente presente 1) un resultado positivo en la prueba de detección del antígeno de superficie de la hepatitis B O 2) un resultado positivo en la prueba de detección de anticuerpos frente al antígeno central (core) del virus de la hepatitis B Y un resultado positivo en la prueba de detección del ADN del VHB Presentar anticuerpos frente al virus de la inmunodeficiencia humana.
    • Presentar tuberculosis (TB) activa.
    • Presentar un riesgo alto de infección o haber presentado recientemente signos de infección clínicamente importante.
    • Haber padecido linfoma, leucemia o cualquier neoplasia maligna en el transcurso de los últimos 5 años, excepto carcinoma basocelular o carcinoma epitelial escamoso de la piel.
    • Haber recibido una vacuna elaborada con microbios vivos (atenuada) en el transcurso de los 28 días anteriores al período basal o tener previsto recibir una vacuna de este tipo durante el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Part A:
    • The safety endpoints evaluated will include but are not limited to the following:
    o TEAEs, AESIs, SAEs
    o Clinical laboratory tests, vital signs, physical examinations


    Part B:
    • proportion of subjects who achieve ACR20
    • The safety endpoints evaluated will include but are not limited to the following:
    o TEAEs, AESIs, SAEs
    o clinical laboratory tests, vital signs, physical examinations
    Parte A:
    • Entre los criterios de valoración de la seguridad que se evaluarán se incluyen:
    o Los AAST, los AAIE y los AAG.
    o Los análisis clínicos, las constantes vitales y las exploraciones físicas.
    Parte B:
    • Porcentaje de pacientes que alcancen una respuesta ACR20.
    • Entre los criterios de valoración de la seguridad que se evaluarán se incluyen:
    o Los AAST, los AAIE y los AAG.
    o Los análisis clínicos, las constantes vitales y las exploraciones físicas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part A: Week 4
    Part B: Week 12
    Parte A: Semana 4
    Parte B: Semana 12
    E.5.2Secondary end point(s)
    Part A: N/A
    Part B:

    • Proportions of subjects achieving ACR50 and ACR70
    • Change from baseline in the DAS28-hsCRP
    • Proportion of subjects achieving LDA based on DAS28-hsCRP
    • Proportion of subjects achieving clinical remission based on DAS28-hsCRP
    • Population PK model estimate of clearance
    Parte A: No corresponde.
    Parte B:
    • Porcentaje de pacientes que alcancen una respuesta ACR50 y una respuesta ACR70.
    • Variación respecto a los valores basales en la DAS28-PCRas.
    • Porcentaje de pacientes que alcancen una ABE según la DAS28-PCRas.
    • Porcentaje de pacientes que alcancen una remisión clínica de acuerdo con la DAS28-PCRas.
    • Cálculo del aclaramiento según un modelo de farmacocinética poblacional.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part B: Week 12
    Parte B: Semana 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Argentina
    Australia
    Austria
    Germany
    Italy
    Japan
    Korea, Republic of
    Mexico
    Poland
    Slovakia
    South Africa
    Spain
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Ultima visita del ultimo paciente
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 164
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 276
    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)
    Study drug is experimental and will be provided to study subjects only according to the protocol; it will not be made available to subjects after they have completed or discontinued from the study unless the subject qualifies to continue study drug in another protocol.
    El fármaco del estudio es experimental y se proporcionará a los pacientes del estudio únicamente de conformidad con el protocolo; los pacientes no podrán continuar recibiéndolo una vez que hayan completado o interrumpido su participación en el estudio, a menos que el paciente se considere idóneo para seguir recibiendo el fármaco del estudio en otro protocolo.
    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 Decision2017-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-20
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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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