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    Summary
    EudraCT Number:2020-004336-16
    Sponsor's Protocol Code Number:CC-93538-EE-001
    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:2022-01-12
    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 number2020-004336-16
    A.3Full title of the trial
    A Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis
    Estudio de fase 3, multicéntrico, internacional, aleatorizado, doble ciego, controlado con placebo, de inducción y mantenimiento para evaluar la eficacia y la seguridad de CC-93538 en sujetos adultos y adolescentes con esofagitis eosinofílica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis
    Un estudio para evaluar la eficacia y la seguridad de CC-93538 en pacientes adultos y adolescentes con esofagitis eosinofílica
    A.4.1Sponsor's protocol code numberCC-93538-EE-001
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1259-1065
    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 SponsorCelgene International II Sàrl
    B.1.3.4CountrySwitzerland
    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 supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointGSM-CT
    B.5.3 Address:
    B.5.3.1Street Address86 Morris Avenue
    B.5.3.2Town/ citySummit
    B.5.3.3Post code07901
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34914229000
    B.5.6E-mailclinical.trials@bms.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 nameCendakimab
    D.3.2Product code CC-93538
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCendakimab
    D.3.9.2Current sponsor codeCC-93538
    D.3.9.4EV Substance CodeSUB201796
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    EOSINOPHILIC ESOPHAGITIS
    ESOFAGITIS EOSINOFÍLICA
    E.1.1.1Medical condition in easily understood language
    Eosinophilic esophagitis (EoE) is a chronic disease that affects food intake and quality of life.
    La esofagitis eosinofílica (EEo) es una enfermedad crónica que afecta a la ingesta de comida y a la calidad de vida.
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10064220
    E.1.2Term Eosinophilic esophagitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -To assess the efficacy of CC-93538 versus placebo in reducing dysphagia symptoms at 24 weeks
    -To assess the efficacy of CC-93538 versus placebo in reducing esophageal eosinophil counts at 24 weeks
    - Evaluar la eficacia de CC-93538 comparado con placebo en la reducción de los síntomas de disfagia a las 24 semanas.
    - Evaluar la eficacia de CC-93538 en comparación con un placebo para reducir los recuentos de eosinófilos esofágicos a las 24 semanas.
    E.2.2Secondary objectives of the trial
    -To assess the efficacy of CC-93538 versus placebo at 24 weeks in improving:
    Endoscopic features of eosinophilic esophagitis (EoE)
    Histologic features of EoE
    -To assess the persistence of effect of CC-93538 at 48 weeks in reducing:
    Dysphagia symptoms
    Esophageal eosinophil counts
    -To assess the persistence of effect of CC-93538 through administration of a less frequent dosing regimen at 48 weeks in reducing:
    Dysphagia symptoms
    Esophageal eosinophil counts
    -To assess the persistence of effect of CC-93538 at 48 weeks in improving:
    Endoscopic features of EoE
    Histologic features of EoE
    -To evaluate the time to and frequency of EoE flare events and use of rescue therapy during the study
    -To evaluate the safety and tolerability of CC-93538 including characterization of the immunogenicity profile
    -To assess trough concentrations of CC-93538 in subjects with EoE
    - Evaluar la eficacia de CC-93538 frente a placebo a las 24 semanas en la mejoría de:
    Características endoscópicas de la EEo
    Características histológicas de la EEo
    - Evaluar la persistencia del efecto de CC-93538 a las 48 semanas en la reducción de:
    Síntomas de disfagia
    Recuento de eosinófilos esofágicos
    - Evaluar la persistencia del efecto de CC-93538 mediante la administración de una pauta posológica con menor frecuencia a las 48 semanas para reducir:
    Síntomas de disfagia
    Recuento de eosinófilos esofágicos
    - Evaluar la persistencia del efecto de CC-93538 a las 48 semanas en la mejoría de:
    Características endoscópicas de la EEo
    Características histológicas de la EEo
    - Evaluar el tiempo y la frecuencia de episodios de exacerbación de la EEo y el uso de tratamiento de rescate durante el estudio.
    - Evaluar la seguridad y tolerabilidad de CC-93538, incluida la caracterización del perfil de inmunogenicidad.
    - Evaluar las concentraciones mínimas de CC-93538 en sujetos con EEo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Endolumenal Functional Lumen Imaging Probe (EndoFLIP TM) Sub-
    study
    Objective: An optional sub-study will be performed at a subset of clinical sites utilizing an Endolumenal Functional Lumen Imaging Probe (EndoFLIP) to evaluate the effects of CC-93538 on esophageal distensibility.
    Version: Protocol version Final 30Sep2020
    Título: Subestudio de sonda de imagen funcional endoluminal (EndoFLIP TM)

    Objetivo: Se realizará un subestudio opcional en un subgrupo de centros clínicos que utilicen una sonda de imagen funcional endoluminal (EndoFLIP) para evaluar los efectos de CC-93538 sobre la distensibilidad esofágica.
    Versión: Versión final del protocolo 30Sep2020
    E.3Principal inclusion criteria
    •Male or female patients aged ≥ 12 and ≤75 years, with a body weight of > 40 kg.
    •Histologic evidence of EoE, defined as a peak count of ≥ 15 eos/HPF at 2 levels of the esophagus.
    •Subject-reported history of 4 or more Dysphagia Days within 2 consecutive weeks prior to end of screening.
    •Lack of complete response to an adequate trial of PPI (8 weeks). Subjects on a PPI must have been on a stable dose for at least 4 weeks prior to first Screening Visit and agree to continue the same dose throughout the study.
    •Subjects currently receiving inhaled corticosteroids, leukotriene receptor antagonists, or mast cell stabilizers for indications other than EoE, or medium potency topical corticosteroids for dermatologic conditions, must maintain stable doses for at least 4 weeks prior to the first Screening Visit and throughout the duration of the study.
    •Subjects must agree to maintain a stable diet (including any food elimination for the treatment of food allergy or EoE) and not introduce any changes in their diet from the first Screening Visit to the end of the study.
    •FCBP must have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy and agree to practice a highly effective method of contraception until 5 months after the last dose.
    •Pacientes de ambos sexos de 12 a 75 años de edad, ambos inclusive, con un peso corporal superior a 40 kg.
    •Pruebas histológicas de EEo, definida como un recuento máximo ≥15 eos/CGA en dos niveles del esófago.
    •Antecedentes comunicados por el paciente de 4 o más días de disfagia en las 2 semanas consecutivas previas al final de la selección.
    •Falta de respuesta completa a una prueba adecuada de un IBP (8 semanas). Los pacientes tratados con un IBP deberán haber recibido una dosis estable durante al menos 4 semanas antes de la primera visita de selección y comprometerse a continuar con la misma dosis durante todo el estudio.
    •Los pacientes que estén recibiendo corticosteroides inhalados, antagonistas del receptor de leucotrienos o estabilizadores de mastocitos para indicaciones distintas de la esofagitis eosinofílica, o corticosteroides tópicos de potencia intermedia para tratar enfermedades dermatológicas, deberán mantener dosis estables durante al menos 4 semanas antes de la primera visita de selección y durante todo el estudio.
    •Los pacientes deberán comprometerse a mantener una dieta estable (incluida cualquier eliminación de alimentos para tratar alergias alimentarias o la esofagitis eosinofílica) y no introducir cambios en su dieta desde la primera visita de selección hasta el final del estudio.
    •Las MEF deberán dar negativo en dos pruebas de embarazo, verificadas por el investigador, antes de iniciar el tratamiento del estudio y comprometerse a utilizar un método anticonceptivo muy eficaz hasta 5 meses después de la última dosis.
    E.4Principal exclusion criteria
    •Clinical or endoscopic evidence of other diseases that may affect the histologic, endoscopic, and clinical symptom evaluation for this study.
    •Other GI disorders such as active Helicobacter pylori infection, esophageal varices, gastritis, colitis, celiac disease, Mendelian disorder associated with EoE, liver function impairment; or a known HFI.
    •Evidence of a severe endoscopic structural abnormality in the esophagus.
    •Esophageal dilation for symptom relief within 8 weeks prior to first Screening Visit or during the Screening Period, or if esophageal dilation is anticipated within 48 weeks of dosing during the study.
    •Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to the first Screening Visit.
    •Treatment with a high potency topical corticosteroid for dermatologic use, or a systemic corticosteroid within 8 weeks of the first Screening Visit.
    •Treatment with a swallowed topical corticosteroid, leukotriene receptor antagonist, or mast cell stabilizer for EoE, within 4 weeks of the first Screening Visit.
    •Treatment with oral or sublingual immunotherapy within 6 months of the first Screening Visit (any use will be prohibited during the study). SC immunotherapy may be allowed if on stable doses for at least 3 months prior to the first Screening Visit and during the study.
    •Actively successful dietary modification adherence (e.g. food elimination diet), resulting in a complete response to EoE.
    •Prior treatment with CC-93538 during a Phase 1 or 2 clinical study.
    •Receipt of a live attenuated vaccine within 4 weeks of the first Screening Visit.
    •Any disease that would affect the conduct of the protocol or interpretation of the study results, or would put a patient at risk by participating in the study (e.g. severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, cardiovascular condition, neurologic disorder, or psychiatric illness that compromises the subject's ability to accurately document symptoms of EoE).
    •Active or ongoing infections including parasitic/helminthic, hepatitis, TB, or AIDS.
    •Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks of the first Screening Visit.
    •Females who are pregnant or lactating.
    •Datos clínicos o endoscópicos de otras enfermedades que puedan afectar a la evaluación histológica, endoscópica y clínica de los síntomas de este estudio.
    •Otros trastornos digestivos, como infección activa por Helicobacter pylori, varices esofágicas, gastritis, colitis, enfermedad celíaca, trastorno mendeliano asociado a esofagitis eosinofílica, disfunción hepática o IHG conocida.
    •Evidencia de una anomalía estructural endoscópica grave en el esófago.
    •Dilatación esofágica para alivio de los síntomas en las 8 semanas previas a la primera visita de selección o durante el período de selección, o si se prevé dilatación esofágica en las 48 semanas previas a la administración durante el estudio.
    •Signos de inmunodepresión o de haber recibido inmunodepresores o inmunomoduladores sistémicos en las 5 semividas previas a la primera visita de selección.
    •Tratamiento con un corticosteroide tópico muy potente para uso dermatológico o un corticosteroide sistémico en las 8 semanas previas a la primera visita de selección.
    •Tratamiento con un corticosteroide tópico tragado, un antagonista del receptor de leucotrienos o un estabilizador de los mastocitos para la esofagitis eosinofílica en las 4 semanas previas a la primera visita de selección.
    •Tratamiento con inmunoterapia oral o sublingual en los 6 meses previos a la primera visita de selección (durante el estudio estará prohibido cualquier uso). Podrá permitirse la inmunoterapia SC siempre que se haya administrado en dosis estables durante al menos 3 meses antes de la primera visita de selección y durante el estudio.
    •Cumplimiento satisfactorio activo de las modificaciones alimentarias (p. ej., dieta de eliminación de alimentos) que haya determinado una respuesta completa a la esofagitis eosinofílica.
    •Tratamiento previo con CC-93538 durante un estudio clínico de fase 1 o 2.
    •Recepción de una vacuna de microorganismos vivos atenuados en las 4 semanas previas a la primera visita de selección.
    •Cualquier enfermedad que pueda afectar a la realización del protocolo o a la interpretación de los resultados del estudio o que suponga un riesgo para el paciente si participa en el estudio (p. ej., asma grave no controlada, infección causante de eosinofilia, síndrome hipereosinófilo, enfermedad cardiovascular, trastorno neurológico o enfermedad psiquiátrica que comprometa la capacidad del paciente para documentar con exactitud los síntomas de esofagitis eosinofílica).
    •Infecciones activas o en curso, como parasitarias o helmínticas, hepatitis, tuberculosis o sida.
    •Síndrome respiratorio agudo grave por infección por coronavirus 2 (SARS-CoV-2) en las 4 semanas previas a la primera visita de selección.
    •Embarazo o lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    •The mean change in dysphagia days (DD), evaluated over the prior 14-day period using the modified Daily Symptom Diary (mDSD), from baseline to Week 24
    •The proportion of subjects with eosinophilic histologic response defined as a peak esophageal eosinophil count ≤ 6/high-power field (hpf) at Week 24
    - Variación media en los días de disfagia (DD), evaluados durante el período de 14 días previo mediante el diario de síntomas diarios modificado (DSDm), entre el momento basal y la semana 24.
    - Proporción de sujetos con respuesta histológica eosinofílica, definida como un recuento máximo de eosinófilos en el esófago ≤ 6/campo de gran aumento (CGA) en la semana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Semana 24
    E.5.2Secondary end point(s)
    1/The proportion of subjects with eosinophilic histologic response defined as a peak esophageal eosinophil count < 15/hpf at Week 24
    2/The mean change in the endoscopic features of EoE as measured by the EoE Endoscopic Reference Score (EREFS) from baseline to Week 24
    3/The mean change in the mean adjusted histology grade score as measured by the EoE histology scoring system (EoEHSS) from baseline to Week 24
    4/The mean change in the mean adjusted histology stage score as measured by the EoE histology scoring system (EoEHSS) from baseline to Week 24
    5/The mean change in the modified Daily Symptom Diary (mDSD) composite score from baseline to Week 24
    6/The mean change in dysphagia days (DD), evaluated over the prior 14-day period using the modified Daily Symptom Diary (mDSD), from baseline to Week 48
    7/The proportion of subjects with eosinophilic histologic response defined as a peak esophageal eosinophil count ≤ 6/high-power field (hpf) at Week 48
    8/Safety and tolerability evaluated by the incidence, severity, and relationship to CC-93538 of adverse events (AEs), serious adverse events (SAEs), clinical laboratory abnormalities, changes in vital signs, physical examination abnormalities, and the presence of anti-drug antibodies
    9/Measurements of trough concentrations of CC-93538 in subjects with EoE
    10/The proportion of subjects with a ≥ 50% decrease in dysphagia days (DD) from baseline at Week 24
    11/The proportion of subjects who achieve histologic response defined as a peak esophageal eosinophil count ≤ 6/hpf at Week 24 and dysphagia symptom response defined as the proportion of subjects with ≥ 50% decrease in dysphagia days (DD) from baseline at Week 24
    1/Proporción de sujetos con respuesta histológica eosinofílica, definida como un recuento máximo de eosinófilos en el esófago < 15/CGA en la semana 24.
    2/Variación media de las características endoscópicas de la EEo determinada mediante la puntuación de referencia endoscópica de la EEo (EREFS) entre el momento basal y la semana 24.
    3/Variación media de la puntuación media ajustada del grado histológico, determinada mediante el sistema de puntuación histológica de la EEo (EoEHSS), entre el momento basal y la semana 24.
    4/Variación media de la puntuación media ajustada del estadio histológico, determinada mediante el sistema de puntuación histológica de la EEo (EoEHSS), entre el momento basal y la semana 24.
    5/Variación media de la puntuación combinada del diario de síntomas diarios modificado (DSDm) entre el momento basal y la semana 24.
    6/Variación media en los días de disfagia (DD), evaluados durante el período de 14 días previo mediante el diario de síntomas diarios modificado (DSDm), entre el momento basal y la semana 48.
    7/Proporción de sujetos con respuesta histológica eosinofílica, definida como un recuento máximo de eosinófilos en el esófago ≤ 6/CGA en la semana 48.
    8/ Seguridad y tolerabilidad evaluadas mediante la incidencia, intensidad y relación con CC-93538 de acontecimientos adversos (AA), acontecimientos adversos graves (AAG), anomalías analíticas, variaciones de las constantes vitales, anomalías de la exploración física y presencia de anticuerpos contra el fármaco.
    9/Determinaciones de las concentraciones mínimas de CC-93538 en sujetos con EEo.
    10/ Proporción de sujetos con una disminución ≥ 50 % en los días de disfagia (DD) entre el momento basal y la semana 24
    11/ Proporción de sujetos con respuesta histológica eosinofílica, definida como un recuento máximo de eosinófilos en el esófago < 6/ CGA en la semana 24 y respuesta a los síntomas de disfagia definida como la proporción de sujetos con una disminución ≥ 50 % en los días de disfagia (DD) entre el momento basal y la semana 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    1/ week 24
    2/ week 24
    3/ week 24
    4/ week 24
    5/ week 24
    6/ week 48
    7/ week 48
    8/ Determined through the whole study
    9/ Determined through the whole study
    10/ Week 24
    11/ Week 24
    1/ semana 24
    2/ semana 24
    3/ semana 24
    4/ semana 24
    5/ semana 24
    6/ semana 48
    7/ semana 48
    8/ Determinadas a lo largo de todo el estudio
    9/ Determinadas a lo largo de todo el estudio
    10/ semana 24
    11/ semana 24
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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
    Belgium
    Canada
    Czechia
    Germany
    Israel
    Italy
    Japan
    New Zealand
    Poland
    Portugal
    Spain
    Switzerland
    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
    The End of Study is defined as either the date of the last visit of the last subject to complete the post-treatment follow-up, or the date of receipt of the last data point from the last subject that is required for primary, secondary, and/or exploratory analysis, as pre-specified in the protocol, whichever is the later date.
    El final del estudio se define como la fecha de la última visita del último sujeto que finalice el seguimiento posterior al tratamiento o la fecha de recepción de los últimos datos correspondientes al último sujeto que sean necesarios para los análisis principales, secundarios o exploratorios, como se establece en el protocolo, la que sea posterior.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months8
    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 months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 30
    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: 30
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 366
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 399
    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)
    Optional Open-Label Extension Study (OLE; Study CC-93538-EE-002)
    Estudio de extensión abierto opcional (OLE; Estudio CC-93538-EE-002)
    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 Decision2022-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-03
    P. End of Trial
    P.End of Trial StatusOngoing
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