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    Summary
    EudraCT Number:2017-003699-30
    Sponsor's Protocol Code Number:BGB-A317-302
    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:2018-02-15
    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 number2017-003699-30
    A.3Full title of the trial
    A Randomized, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the anti-PD-1 Antibody BGB-A317 versus Chemotherapy as Second Line Treatment in Patients with Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma
    Estudio de Fase 3, aleatorizado, controlado, abierto y global, comparativo de la eficacia de BGB-A317, un anticuerpo anti-PD-1, frente a quimioterapia como segunda línea de tratamiento en pacientes con carcinoma esofágico epidermoide avanzado no resecable/metastásico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 study of Antibody BGB-A317 versus Chemotherapy in Patients with Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma
    Estudio de Fase 3 del anticuerpo BGB-A317 frente a quimioterapia en pacientes con carcinoma esofágico epidermoide avanzado no resecable/metastásico.
    A.4.1Sponsor's protocol code numberBGB-A317-302
    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 SponsorBeiGene, Ltd.c/o BeiGene USA, 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 supportBeiGene, Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBeiGene, Ltd.
    B.5.2Functional name of contact pointBeiGene Clinical Support
    B.5.3 Address:
    B.5.3.1Street AddressUSA
    B.5.3.2Town/ cityUSA
    B.5.3.3Post codeUSA
    B.5.3.4CountryUnited States
    B.5.6E-mailBeigeneClinicalSupportUS@beigene.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 nameBGB-A317
    D.3.4Pharmaceutical form Concentrate for 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 INNBGB-A317
    D.3.9.1CAS number 1858168-59-8
    D.3.9.2Current sponsor codeBGB-A317
    D.3.9.3Other descriptive nameBGB-A317
    D.3.9.4EV Substance CodeSUB189550
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Paclitaxel 6mg/ml Concentrate For Solution For Infusion
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group PTC ehf.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namePaclitaxel 6mg/ml Concentrate For Solution For Infusion
    D.3.4Pharmaceutical form Concentrate for 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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name TAXOTERE 20 mg/1 ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTAXOTERE
    D.3.4Pharmaceutical form Concentrate for 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 INNDOCETAXEL TRIHYDRATE
    D.3.9.3Other descriptive nameDOCETAXEL TRIHYDRATE
    D.3.9.4EV Substance CodeSUB25446
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name CAMPTO 20 mg/ml, concentrate for solution for infusion.
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameCAMPTO
    D.3.4Pharmaceutical form Concentrate for 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 INNIRINOTECAN HYDROCHLORIDE TRIHYDRATE
    D.3.9.3Other descriptive nameIRINOTECAN HYDROCHLORIDE TRIHYDRATE
    D.3.9.4EV Substance CodeSUB45873
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma(ESCC)
    Carcinoma esofágico epidermoide avanzado no resecable/metastásico
    E.1.1.1Medical condition in easily understood language
    Advanced Unresectable or Metastatic Esophageal Squamous Cell Carcinoma(ESCC)
    Carcinoma esofágico epidermoide avanzado no resecable/metastásico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10055476
    E.1.2Term Esophageal squamous cell carcinoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To compare the overall survival (OS) following treatment with BGB-A317 vs. investigator chosen chemotherapy (ICC) when given as second line treatment in patients with advanced unresectable/metastatic Esophageal Squamous Cell Carcinoma (ESCC)
    • Comparar la supervivencia global (overall survival, OS) tras el tratamiento con BGB-A317 frente a la quimioterapia elegida por el investigador (investigator chosen chemotherapy, ICC) en su administración como tratamiento de segunda línea a pacientes con carcinoma esofágico epidermoide (esophageal squamous cell carcinoma, ESCC) avanzado no resecable/metastásico
    E.2.2Secondary objectives of the trial
    •The following secondary endpoints will be compared between BGB-A317 and ICC as assessed by Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria:
    o Objective response rate (ORR)
    o Progression-free survival (PFS)
    o Duration of response (DOR)
    • To compare patient reported outcomes of health-related quality of life (HRQoL) between the BGB-A317 and the chemotherapy treatments
    • To compare the safety and tolerability between BGB-A317 and the chemotherapy treatments
    • Comparar los criterios secundarios de valoración siguientes, a juzgar por el investigador según los criterios de evaluación de la respuesta en tumores sólidos (Response Evaluation Criteria in Solid Tumors, RECIST) v1.1, entre BGB-A317 y la quimioterapia elegida por el investigador:
    o Tasa de respuesta objetiva (objective response rate, ORR)
    o Supervivencia sin progresión (progression-free survival, PFS)
    o Duración de la respuesta (duration of response, DOR)
    • Comparar los desenlaces comunicados por los pacientes sobre la calidad de vida relacionada con la salud (health-related quality of life, HRQoL) entre BGB-A317 y los tratamientos de quimioterapia
    • Comparar la seguridad y la tolerabilidad entre BGB-A317 y los tratamientos de quimioterapia
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Safety Run-in Substudy Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-PD-1 Monoclonal Antibody BGB A317 in Japanese Patients with Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma
    Protocol Identifier: BGB-A317-302 Substudy
    Primary Study Objectives:
    • To assess the safety and tolerability of BGB-A317 in Japanese patients with advanced unresectable esophageal squamous cell carcinoma (ESCC)
    • To confirm the pivotal Phase 3 dose of BGB-A317 in Japanese patients
    • To characterize the pharmacokinetics of BGB-A317 in Japanese patients
    Secondary Study Objectives:
    • To assess the preliminary antitumor activity of BGB-A317
    • To assess host immunogenicity to BGB-A317
    E.3Principal inclusion criteria
    1. Pathologically (histologically or cytologically) confirmed diagnosis of esophageal squamous cell carcinoma (ESCC)
    2. Tumor progression during or after first-line treatment for advanced unresectable / metastatic ESCC
    3. At least one measurable/evaluable lesion by RECIST v1.1
    4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to randomization
    5. Adequate End organ function
    1. Diagnóstico de carcinoma esofágico epidermoide confirmado por anatomía patológica (histología o citología).
    2. Progresión del tumor durante el tratamiento de primera línea por enfermedad avanzada no resecable/ metastásica o después de este.
    3. Todos los pacientes también deben presentar >=1 lesión evaluable según los RECIST v1.1 en el plazo de los 28 días anteriores a la aleatorización.
    4. Puntuación del estado funcional del ECOG (Eastern Cooperative Oncology Group) <=1
    5. Nivel de funcionamiento orgánico adecuado.
    E.4Principal exclusion criteria
    1. Receipt of 2 or more prior systemic treatments for advanced/metastatic unresectable ESCC
    2. History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula within 6 months prior to randomization
    3. Apparent tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula in the study treatment assessed by investigator
    4. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
    5. Received prior therapies targeting PD-1 or PD-L1
    6. Prior malignancy active within the previous 2 years (exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast)
    7. Active brain or leptomeningeal metastasis.
    8. Has active autoimmune disease or history of autoimmune diseases at high risk for relapse
    9. Known history of, or any evidence of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis diagnosed based on imaging or clinical findings, or uncontrolled systemic diseases, including diabetes, hypertension, acute lung diseases, etc
    10. Known history of Human Immunodeficiency Virus (HIV)
    11. Has cardiovascular risk factors
    12. Pregnant or breastfeeding woman.
    1. Recepción de 2 o más tratamientos sistémicos previos para ESCC avanzado / metastásico no resecable.
    2. Antecedentes de perforación gastrointestinal y / o fístula o fístula aortoesofágica dentro de los 6 meses previos a la aleatorización.
    3. Invasión tumoral aparente en órganos localizados adyacentes al sitio de la enfermedad esofágica (p. Ej., Aorta o vías respiratorias) con un mayor riesgo de fístula en el tratamiento del estudio evaluado por el investigador.
    4. Derrame pleural incontrolable, derrame pericárdico, o ascitis que requieren drenaje frecuente.
    5. Recibió terapias anteriores dirigidas a PD-1 o PD-L1.
    6. Malignidad previa activa dentro de los 2 años previos (las excepciones incluyen el tumor bajo investigación en este ensayo y cánceres localmente recurrentes que han sido sometidos a tratamiento curativo, como cáncer de piel de células escamosas o basoescamoso resecado, cáncer superficial de vejiga o carcinoma in situ de próstata, cuello uterino o mama).
    7.Metástasis cerebral activa o leptomeníngea.
    8.Tiene enfermedad autoinmune activa o historia de enfermedades autoinmunes con alto riesgo de recaída.
    9. Antecedentes conocidos de, o alguna evidencia de enfermedad pulmonar intersticial, neumonitis no infecciosa, fibrosis pulmonar diagnosticada en base a hallazgos por imagen o clínicos, o enfermedades sistémicas no controladas, incluyendo diabetes, hipertensión, enfermedades pulmonares agudas, etc.
    10. Antecedente conocido de Virus de Inmunodeficiencia Humana (VIH).
    11. Tiene factores de riesgo cardiovasculares.
    12. Mujeres embarazadas o en periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    • OS - defined as the time from the date of randomization until the date of death due to any cause
    SG-Supervivencia Global-definida como el tiempo desde la fecha de aleatorización hasta la fecha de la muerte debida a cualquier causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The final analysis of OS will occur at approximately 3 years.
    El análisis final de SG ocurrirá a los 3 años aproximadamente.
    E.5.2Secondary end point(s)
    • ORR - defined as the proportion of patients who had complete response (CR) or partial response (PR) assessed by the Investigators per RECIST v1.1
    • PFS - defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the Investigators per RECIST v1.1 or death, whichever occurs first
    • DOR- defined as the time from the first determination of an objective response until the first documentation of progression assessed by the Investigators per RECIST v1.1 or death, whichever comes first
    • HRQoL assessment
    • The incidence and severity of adverse events
    -Tasa de respuesta objetiva ORR) :definida como el porcentaje de pacientes con respuesta completa (complete response, CR) o respuesta parcial (partial response, PR) a juzgar por la evaluación del investigador según los RECIST v1.1
    -Supervivencia sin progression (PFS): definida como el tiempo transcurrido desde la fecha de la aleatorización hasta la fecha de la primera documentación de progresión de la enfermedad, a juzgar por la evaluación del investigador según los RECIST v1.1, o la muerte, eligiéndose la primera de estas situaciones que tenga lugar
    -Duración de la respuesta (DOR): definida como el tiempo transcurrido desde la primera determinación de una respuesta objetiva hasta la primera documentación de progresión, a juzgar por la evaluación del investigador según los RECIST v1.1, o la muerte, eligiéndose la primera de estas situaciones que tenga lugar.
    - Evaluación de la Calidad de vida relacionada con la salud (HRQoL)
    -Incidencia y severidad de los acontecimientos adversos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ORR as assessed by investigator
    PFS as assessed by investigator
    DOR as assessed by investigator
    HRQoL as assessed by European EORTC QLQ-C30 index, the European esophageal cancer specific module OES18, and the EQ-5D-5L.
    Incidence and severity of adverse events according to NCI-CTCAE v4.03
    Tasa de respuesta objetiva (ORR) evaluada por el investigador.
    Supervivencia sin progresión (PFS) evaluada por el investigador.
    Duración de la respuesta (DOR) evaluada por el investigador.
    Calidad de vida relacionada con la salud, mediante evaluación del estado de salud general del sujeto con el cuestionario de calidad de vida de la European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, el módulo de cáncer esofágico de la EORTC QLQ-OES18 y el EQ-5D-5L.
    Incidencia y severidad de los acontecimientos adversos, según los National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03
    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 Yes
    E.6.13.1Other scope of the trial description
    Assessment of Immunogenicity
    Evaluación de la inmunogenicidad
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA54
    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
    Belgium
    France
    Germany
    Italy
    Japan
    Korea, Republic of
    Spain
    Taiwan
    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
    LVLS
    Última Visita del Último Sujeto
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 101
    F.4.2.2In the whole clinical trial 450
    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)
    Patients assigned to BGB-A317, who in the opinion of the Investigator, continue to benefit from BGB-A317at study termination, may continue treatment after discussion and agreement by the Sponsor. For these patients, BGB-A317 will be provided by the Sponsor until they can be transitioned to commercial supply.
    Pacientes asignados a BGB-A317 quien en opinión del investigador continuen beneficiándose de BGB-A317 cuando el estudio termine, podrían continuar el tratamiento después de acordarlo con el promotor. Para esos pacientes, BGB-A317 será proporcionado por el promotor hasta que se les pueda proporcionar el medicamento comercializado.
    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 Decision2018-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-05
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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