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    Summary
    EudraCT Number:2017-002350-36
    Sponsor's Protocol Code Number:GA39925
    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:2018-06-06
    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 number2017-002350-36
    A.3Full title of the trial
    A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
    ESTUDIO DE FASE II MULTICÉNTRICO, ALEATORIZADO,
    DOBLE CIEGO, CON DOBLE SIMULACIÓN, CONTROLADO
    CON PLACEBO, DE GRUPOS PARALELOS, PARA
    EVALUAR LA EFICACIA, LA SEGURIDAD Y LA
    FARMACOCINÉTICA DE UTTR1147A EN COMPARACIÓN
    CON PLACEBO Y EN COMPARACIÓN CON VEDOLIZUMAB,
    EN PACIENTES CON COLITIS ULCEROSA DE MODERADA A
    GRAVE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.
    Estudio para evaluar la eficacia, la seguridad y la farmacocinética de UTTR1147A en comparación con placebo y en comparación con Vedolizumab, en pacientes con colitis ulcerosa de moderada a grave.
    A.4.1Sponsor's protocol code numberGA39925
    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 SponsorRoche Farma, S.A por delegación de Genentech, 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 supportGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34913257300
    B.5.5Fax number+34913248195
    B.5.6E-mailspain.start_up_unit@roche.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.3.2Product code UTTR1147A/RO7021610 (Active)
    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 INNn.a.
    D.3.9.2Current sponsor codeRO7021610
    D.3.9.3Other descriptive nameUTTR1147A, IL22-Fc, IL-22Fc
    D.3.9.4EV Substance CodeSUB179397
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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 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 Yes
    D.3.11.13.1Other medicinal product typeHuman interleukin-22 (IL-22) fusion protein
    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 Entyvio 300mg
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    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.3.2Product code RO7246311
    D.3.4Pharmaceutical form Powder for 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 INNVedolizumab
    D.3.9.1CAS number 943609-66-3
    D.3.9.2Current sponsor codeRO7246311
    D.3.9.3Other descriptive nameVEDOLIZUMAB
    D.3.9.4EV Substance CodeSUB30452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 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 Yes
    D.3.11.13.1Other medicinal product typehumanised IgG1 monoclonal antibody
    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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative colitis (UC)
    Colitis Ulcerosa (CU)
    E.1.1.1Medical condition in easily understood language
    UC is a chronic, inflammatory bowel disease that results in bloody diarrhea
    CU es una enfermedad crónica e inflamatoria del intestino que resulta en diarreas sangrantes
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10033007
    E.1.2Term Other ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045366
    E.1.2Term Ulcerative colitis, unspecified
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10066678
    E.1.2Term Acute ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10075635
    E.1.2Term Acute hemorrhagic ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the efficacy of UTTR1147A compared with placebo and compared with vedolizumab based on clinical remission
    •Evaluar la eficacia de UTTR1147A en
    comparación con placebo y en
    comparación con vedolizumab basado en remisión clinica
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of UTTR1147A compared with placebo and compared with vedolizumab based on sustained remission, clinical response, endoscopic healing, endoscopic remission, UC bowel movement/abdominal signs and symptoms, and patient-reported health-related quality of life (QOL)
    • To evaluate the safety of UTTR1147A compared with placebo and compared with vedolizumab
    • To characterize the pharmacokinetics of UTTR1147A in patients with UC
    • To evaluate the immune response to UTTR1147A
    • Evaluar la eficacia de UTTR1147A en
    comparación con placebo y en
    comparación con vedolizumab basado en Remisión mantenida, Respuesta clínica, Curación endoscópica, Remisión endoscópica, Cambio en los signos y síntomas defecatorios /abdominales de la CU y Cambios en la CdV relacionada con la salud
    comunicada por el paciente
    • Evaluar la seguridad de UTTR1147A en comparación con placebo y en comparación con vedolizumab.
    • Caracterizar la farmacocinética de
    UTTR1147A en los pacientes con CU.
    • Evaluar la respuesta inmunitaria a
    UTTR1147A.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18-80 years
    - Diagnosis of UC
    - Moderate to severely active UC, defined by the Mayo Clinic Score
    - Inadequate response, loss of response, or intolerance to prior immunosuppressant treatment and and/or corticosteroid treatment
    - Use of highly effective contraception as defined by the protocol
    -Edad de 18 a 80 años
    -Diagnóstico de CU
    -Confirmación de CU de moderada a grave, definida por la Clinica Mayo
    -Respuesta inadecuada, desaparición de la respuesta o intolerancia al tratamiento
    inmunosupresor previo y/o al tratamiento con corticoesteroides.
    -Uso de métodos anticonceptivos altamente eficaces definidos por el protocolo
    E.4Principal exclusion criteria
    - History of psoriasis or psoriatic arthritis; any other inflammatory skin disorders requiring oral corticosteroids, immunosuppressants, or biological therapy within the previous year and primary sclerosing cholangitis
    - History of cancer as defined by the protocol
    - Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or GI disorders (excluding UC)
    - Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for UC
    - Diagnosis of indeterminate colitis or granulomatous (Crohn's) colitis and toxic megacolon within 12 months prior to screening
    - Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
    - Current fistula or history of fistula, current pericolonic abscess and Stricture (stenosis) of the colon
    - History or current evidence of unresectable colonic mucosal dysplasia and high-grade colonic mucosal dysplasia
    - Prior treatment with vedolizumab, etrolizumab, natalizumab, efalizumab, or any other anti-integrin agents and rituximab
    - Use of prohibited therapies as defined by the protocol prior to randomization
    - Evidence or treatment of infections or history of infections as defined by the protocol
    -Antecedentes de psoriasis o de artritis psoriásica; cualquier otro trastorno inflamatorio de la piel que haya requerido
    corticoesteroides orales, inmunosupresores o un tratamiento biológico en el año anterior y colangitis esclerosante primaria
    -Antecedentes de cáncer tal y como están definidos en el protocolo.
    -Enfermedad concomitante no controlada e importante, como trastornos cardíacos, pulmonares, renales, hepáticos, endocrinos o GI (salvo la CU).
    -Antecedentes de resección colónica extensa, de colectomía subtotal o total, o de proctocolectomía, o intervención quirúrgica programada para la CU.
    -Diagnóstico de colitis indeterminada o de colitis granulomatosa (Crohn) o megacolon tóxico en los 12 meses previos a la selección.
    -Sospecha de colitis isquémica, colitis por radiación o colitis microscópica.
    -Antecedentes o presencia de fístulas, absceso pericolónico en curso y estenosis del colon.
    -Antecedentes o signos de displasia de la mucosa colónica no resecable y de displasia de la mucosa colónica de alto grado.
    -Tratamiento previo con vedolizumab, etrolizumab, natalizumab, efalizumab o cualquier otro
    inhibidor de integrinas y rituximab
    -Uso de terapias prohibidas tal y como están definidas en el protocolo antes de la randomización
    -Evidencia o tratamiento de infección o antecedentes de infecciones tal y como está definido en el protocolo
    E.5 End points
    E.5.1Primary end point(s)
    1. Clinical remission
    1. Remision clinica
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At Week 10
    1. En la semana 10
    E.5.2Secondary end point(s)
    1. Sustained remission
    2. Clinical response
    3. Endoscopic healing
    4. Endoscopic remission
    5. Change from baseline in ulcerative colitis bowel movement signs and symptoms, as assessed by Ulcerative Colitis-Patient-Reported Outcome Signs and Symptoms score (UC PRO/SS)
    6. Change from baseline in UC abdominal signs and symptoms, as assessed by UC PRO/SS score
    7. Change from baseline in patient-reported health related QOL, as assessed by Inflammatory Bowel Disease Questionnaire score
    8. Occurrence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events scale
    9. Change in targeted vital signs, physical findings, and clinical laboratory test results during and following study drug administration
    10. Serum concentration of UTTR1147A at specified time points
    11. Presence of anti-drug antibody (ADA) during the study relative to the presence of ADAs at baseline
    1. Remisión mantenida
    2. Respuesta clínica
    3. Curación endoscópica
    4. Remisión endoscópica
    5. Cambio en los signos y síntomas defecatorios desde el momento basal de la
    CU evaluado mediante la puntuación de Ulcerative Colitis-Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS).
    6. Cambio en los signos y síntomas abdominales de la CU desde el momento basal evaluado mediante la puntuación de Ulcerative Colitis-Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS)
    7. Cambio en la CdV relacionada con la salud
    comunicada por el paciente desde el momento basal evaluado mediante la
    puntuación en el cuestionario IBDQ.
    8. Incidencia e intensidad de los acontecimientos
    adversos, con la intensidad determinada según los CTCAE del NCI
    9. Variación de las constantes vitales, los datos de la exploración física y los resultados analíticos durante
    la administración del fármaco del estudio y después
    10. Concentración sérica de UTTR1147A en puntos temporales especificados.
    11. Presencia de ACF durante el estudio en
    comparación con su presencia en el momento basal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4: At Weeks 10 and 30
    5-7: Baseline to Weeks 10 and 30
    8-9: Up to 45 months
    10: At Weeks 0, 1, 2, 4, 6, 8, 10, 14, 30 and at safety follow-up visit (4 weeks after the last dose of study drug) and at unscheduled visit or
    disease evaluation or early termination
    11: At Weeks 0, 6, 10, 22, 30 and at safety follow-up visit (8 weeks after
    the last dose of study drug) and at unscheduled visit or disease evaluation or early termination
    1-4. En las semanas 10 y 30
    5-7. Desde Basal a las semanas 10 y 30
    8-9. Hasta un maximo de 45 meses
    10. En las semanas 0, 1, 2, 4, 6, 8, 10, 14, 30 y en la visita de seguimiento de seguridad (4 semanas después de la ultima dosis del fármaco del estudio) y en visitas no programadas o de evaluación de la enfermedad o terminación temprana.
    11. En las semanas 0, 6, 10, 22, 30 y en la visita de seguimiento de seguridad (8 semanas después de la ultima dosis del fármaco del estudio) y en visitas no programadas o de evaluación de la enfermedad o terminación temprana.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity; predictive, prognostic, safety, pharmacodynamic biomarkers
    Inmunogenicidad, predictiva, prognosis, seguridad, y biomarcadores farmacodinamicos.
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial10
    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 EEA80
    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
    Bulgaria
    Germany
    Greece
    Hungary
    Ireland
    Israel
    Italy
    Netherlands
    Poland
    Russian Federation
    Serbia
    Spain
    Ukraine
    United Kingdom
    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
    The end of this study is defined as the date when the last patient completes his or her final study visit.
    El final de este estudio se define como la fecha en que el último paciente completa la última visita de seguimiento de seguridad.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 264
    F.4.2.2In the whole clinical trial 330
    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 enrolled in this study will have the opportunity to participate in the Extension Study GA40209 if eligible (see protocol section 3.1.5).
    Los pacientes incluidos en este ensayo tendrán la oportunidad de participar en el estudio de extensión GA40209si son elegibles (ver sección 3.1.5 del 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 Decision2018-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-02
    P. End of Trial
    P.End of Trial StatusOngoing
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