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    Summary
    EudraCT Number:2019-003406-27
    Sponsor's Protocol Code Number:SL0043
    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:2020-05-28
    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 number2019-003406-27
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y la seguridad de dapirolizumab pegol en participantes del estudio con lupus eritematoso sistémico de moderado 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 and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus
    Un estudio para evaluar la eficacia y la seguridad de dapirolizumab pegol en participantes del estudio con lupus eritematoso sistémico de moderado a grave
    A.4.1Sponsor's protocol code numberSL0043
    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 SponsorUCB Biopharma SRL
    B.1.3.4CountryBelgium
    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 supportUCB Biopharma SRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.6E-mailclinicaltrials@ucb.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 nameDapirolizumab pegol
    D.3.2Product code CDP7657
    D.3.4Pharmaceutical form Powder 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 INNDapirolizumab pegol
    D.3.9.2Current sponsor codeDZP
    D.3.9.3Other descriptive nameCDP7657
    D.3.9.4EV Substance CodeSUB30739
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic lupus erythematosus (SLE)
    Lupus eritematoso sistémico (LES)
    E.1.1.1Medical condition in easily understood language
    Systemic lupus erythematosus is a chronic autoimmune inflammatory disease which can present with a chronic disease course but has more often a relapsing-remitting disease course.
    Lupus eritematoso sistémico es una enfermedad inflamatoria autoinmune crónica que puede presentarse con un curso de enfermedad crónica, pero a menudo tiene un curso de enfermedad recidivante-remitente
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    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
    Evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity
    Evaluar la capacidad de DZP como tratamiento complementario a la medicación SOC para lograr una mejora clínicamente relevante a largo plazo de la actividad de la enfermedad de moderada a grave
    E.2.2Secondary objectives of the trial
    Evaluate the ability of DZP as an add-on treatment to SOC medication:
    - to achieve fast, clinically relevant improvement of moderate to severe disease activity
    - to achieve long term control of disease activity
    - to achieve and maintain the treat-to-target goal: low disease activity with low/acceptable corticosteroid dose over time
    - to achieve improvement of disease activity as measured by numerical disease state score commonly used in clinical practice
    - to achieve components of the composite primary endpoints
    - to achieve alternative responder endpoint
    - to achieve endpoints supporting other key secondary endpoints
    To evaluate the safety and tolerability of DZP as add-on treatment to SOC medication
    Evaluar la capacidad de DZP como tratamiento complementario a la medicación SOC para:
    - lograr una mejora clínicamente relevante y rápida de la actividad de la enfermedad de moderada a grave
    - lograr un control a largo plazo de la actividad de la enfermedad
    - lograr y mantener el objetivo de tratamiento al objetivo: actividad baja de la enfermedad con dosis baja/aceptable de corticoesteroides con el tiempo
    - lograr una mejora de la actividad de la enfermedad medida por la puntuación numérica del estado de la enfermedad utilizada comúnmente en la práctica clínica
    - lograr los componentes de los criterios de valoración principales compuestos
    - lograr un criterio de valoración de respuesta alternativo
    - lograr criterios de valoración que respalden otros criterios de valoración secundarios clave
    Evaluar la seguridad y tolerabilidad de DZP como tratamiento complementario a la medicación SOC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Study participant must be >/=16 years of age
    - Study participants who have moderate to severe disease activity due to either persisting active SLE or due to an acute worsening of SLE in the scope of frequent flaring/relapsing-remitting systemic lupus erythematosus (SLE) despite stable standard of care (SOC)medication defined as:
    a. Diagnosed with SLE at least 24 weeks before study entry by a qualified physician
    b. Classified by 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR)classification criteria for SLE
    c. With serological evidence for SLE as demonstrated by at least 1 of the following:
    i) Evidence for anti-dsDNA (in central laboratory at Screening)
    ii) Either complement C3 < lower limit of normal (LLN) OR complement C4 <LLN OR elevated erythrocyte-bound complement C4d as measured by central laboratory
    iii) Antinuclear antibodies with a titer of at least 1:80 confirmed by central laboratory in combination with evidence of at least 1 of the following SLE typical autoantibodies:
    1. Anti-Smith (anti-Sm) antibodies (central laboratory)
    2. Anti-Sjögren’s syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory)
    3. Historic evidence for anti-dsDNA antibodies
    d. Moderately to severely active defined as
    -British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade B in >/=2 organ systems and/or a BILAG 2004 Grade A in >/=1 organ systems at Screening and Baseline Visit
    AND
    -Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) >/=6 at Screening Visit
    AND
    -SLEDAI-2K without labs >/=4 at Baseline Visit
    e. Receiving the following SOC mediation at stable dose:
    - Anti-malarial treatment in combination with corticosteroids and/or immunosuppressants or as stand-alone treatment if justified
    OR
    Treatment with corticosteroids and/or immunosuppressants if anti-malarial treatment is not possible
    - El participante en el estudio debe tener >/=16 años de edad
    - Participantes en el estudio que tengan actividad de la enfermedad de moderada a grave debido a lupus eritematoso sistémico (LES) activo persistente o debido a un empeoramiento agudo del LES en el ámbito de LES con exacerbaciones frecuentes/recidivante-remitente, a pesar del tratamiento estándar (SOC) estable, definido por:
    a. Diagnóstico de LES al menos 24 semanas antes de la inclusión en el estudio por parte de un médico cualificado
    b. Clasificado según los criterios de clasificación del LES de 2019 de la Liga Europea contra el Reumatismo/Colegio Estadounidense de Reumatología (EULAR/ACR)
    c. Con pruebas serológicas de LES según lo demostrado por alguno de los puntos siguientes:
    i) Pruebas de anti-ADNdc (en el laboratorio central en la selección)
    ii) O BIEN un valor de complemento C3 <límite inferior de la normalidad (LIN) O BIEN un valor de complemento C4 <LIN O BIEN aumento de la concentración de C4d unido a eritrocito según lo medido por el laboratorio central
    iii) Anticuerpos antinucleares con un valor mínimo de 1:80 confirmado por el laboratorio central en combinación con datos de al menos 1 de los siguientes autoanticuerpos típicos del LES:
    1. Anticuerpos anti-Smith (anti-Sm) (laboratorio central)
    2. Autoanticuerpo anti-síndrome de Sjögren tipo A (anti-SSA) (Ro)/autoanticuerpo anti-síndrome de Sjögren tipo B (anti-SSB) (La) (laboratorio central)
    3. Datos históricos de anticuerpos anti-ADNdc
    d. Actividad de moderada a grave, definida por:
    - Índice de actividad de la enfermedad del Grupo de evaluación del lupus de las Islas Británicas 2004 (BILAG 2004) de grado B en >/=2 sistemas orgánicos y/o BILAG 2004 de grado A en >/=1 sistemas orgánicos en la visita inicial y de selección
    Y
    - Índice de actividad de la enfermedad del lupus eritematoso sistémico 2000 (SLEDAI-2K) >/=6 en la visita de selección
    Y
    - SLEDAI-2K sin datos de laboratorio >/=4 en la visita inicial
    e. Estar recibiendo el siguiente SOC a dosis estables:
    - Tratamiento antipalúdico en combinación con corticoesteroides y/o inmunosupresores o como tratamiento independiente si está justificado
    O BIEN
    Tratamiento con corticoesteroides y/o inmunosupresores si no es posible el tratamiento antipalúdico
    E.4Principal exclusion criteria
    - Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric systemic lupus erythematosus (SLE)) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study.
    This includes study participants with a life threatening condition
    - Study participant has a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies
    - Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma
    - Study participants with a history of thromboembolic events within 52 weeks of Screening or with a history of catastrophic antiphospholipid syndrome (APS) or saddle pulmonary embolism or with a vascular graft, valvular heart disease, atrial fibrillation, or any other heart rhythm
    disorder associated with an increased risk for thromboembolic events
    - Study participant has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection
    - Study participant had an opportunistic infection within 12 weeks prior to the first study medication infusion.
    - Study participants who have received live/live attenuated vaccines within 6 weeks prior to the first study medication infusion
    - Study participant has clinically significant active or latent infection
    - Study participant has a mixed connective tissue disease, scleroderma, and/or overlap syndrome of these diseases with SLE
    - Study participant takes any protocol defined prohibited concomitant medication or has active lupus that, in the opinion of the Investigator or according to local or international guidances, requires prohibited concomitant medications
    - Study participant has previously been assigned to treatment with DZP in a study evaluating dapirolizumab pegol (DZP)
    - Study participant has participated in another study of an IMP within the previous 12 weeks or 5 half-lives of the investigational medicinal product (IMP) whatever is longer or is currently participating in another study of an IMP
    - Study participant has chronic kidney failure, manifested by estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2, or serum creatinine >2.5 mg/dL, or proteinuria >3 g/day, or protein:creatinine ratio >340 mg/mmol at the Screening Visit
    - El participante en el estudio presenta cualquier afección médica o psiquiátrica (incluidas aquellas afecciones debidas al lupus eritematoso sistémico [LES] neuropsiquiátrico) que, en opinión del investigador, podría poner en peligro o perjudicar a la capacidad del participante en el estudio de participar en este estudio.
    Esto incluye a los participantes en el estudio con alguna afección potencialmente mortal
    - El participante en el estudio tiene antecedentes de reacción anafiláctica a la administración parenteral de medios de contraste, proteínas humanas o murinas, o anticuerpos monoclonales
    - El participante en el estudio tiene antecedentes de neoplasia maligna, excepto los siguientes cánceres tratados: carcinoma cervicouterino in situ, carcinoma basocelular o carcinoma epidermoide dermatológico
    - Participantes en el estudio con antecedentes de acontecimientos tromboembólicos en las 52 semanas anteriores a la selección o con antecedentes de síndrome antifosfolipídico (APS) muy grave o embolia pulmonar en silla de montar o con una prótesis vascular, valvulopatía, fibrilación auricular o cualquier otro trastorno del ritmo cardíaco asociado con un mayor riesgo de acontecimientos tromboembólicos
    - El participante en el estudio presenta pruebas de infección por el virus de la inmunodeficiencia humana (VIH), agammaglobulinemias, deficiencias de linfocitos T o infección por el virus linfotrópico de linfocitos T humano tipo 1
    - El participante en el estudio contrajo una infección oportunista en las 12 semanas anteriores a la primera infusión del medicamento del estudio.
    - Participantes en el estudio que han recibido vacunas vivas/vivas atenuadas en las 6 semanas anteriores a la primera infusión del medicamento del estudio
    - El participante en el estudio presenta una infección activa o latente clínicamente significativa
    - El participante en el estudio tiene una enfermedad mixta del tejido conjuntivo, esclerodermia y/o síndrome de solapamiento de estas enfermedades junto con LES
    - El participante en el estudio toma algún medicamento concomitante prohibido definido en el protocolo o tiene lupus activo que, en opinión del investigador o de acuerdo con las guías locales o internacionales, requiere el uso de medicamentos concomitantes prohibidos
    - El participante en el estudio ha sido asignado previamente a recibir tratamiento con DZP en un estudio que evalúe dapirolizumab pegol (DZP)
    - El participante en el estudio ha participado en otro estudio de un PEI en las 12 semanas previas o 5 semividas del producto en investigación (PEI), lo que sea más largo, o está participando actualmente en otro estudio de un PEI
    - El participante en el estudio presenta insuficiencia renal crónica, manifestada por una tasa de filtración glomerular estimada (TFGe) <30 ml/min/1,73 m^2, o creatinina sérica >2,5 mg/dl, o proteinuria >3 g/día, o cociente proteína:creatinina >340 mg/mmol en la visita de selección
    E.5 End points
    E.5.1Primary end point(s)
    Achievement of BICLA response at Week 48
    Logro de la respuesta BICLA en la semana 48
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 48
    Semana 48
    E.5.2Secondary end point(s)
    1. Achievement of BICLA response at Week 24
    2. Achievement of BICLA response at Week 12
    3. Achievement of prevention of severe BILAG flares through Week 48
    4. Achievement of LLDAS in >/=50% of post-Baseline visits through Week 48
    5. Change from Baseline in SLEDAI-2K at Week 48
    6. Achievement of BILAG improvement without worsening at Week 48
    7. Change from Baseline in PGA at Week 48
    8. Achievement of SRI4 response at Week 48
    9. Achievement of prevention of moderate/severe BILAG flares through Week 48
    10. Time to severe BILAG Flare through Week 48
    11. Time to moderate/severe BILAG flare through Week 48
    12. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
    13. Percentage of participants with serious treatment-emergent adverse events during the study
    14. Percentage of participants with treatment-emergent adverse events of special interest during the study
    15. Percentage of participants with treatment-emergent adverse events of special monitoring during the study
    1. Logro de la respuesta BICLA en la semana 24
    2. Logro de la respuesta BICLA en la semana 12
    3. Logro de la prevención de exacerbaciones graves según BILAG hasta la semana 48
    4. Logro de LLDAS EN >/=50 % de las visitas posteriores al inicio hasta la semana 48
    5. Cambio desde el inicio del SLEDAI-2K en la semana 48
    6. Logro de mejora de BILAG sin empeoramiento en la semana 48
    7. Cambio desde el inicio de la PGA en la semana 48
    8. Logro de la respuesta SRI4 en la semana 48
    9. Logro de la prevención de exacerbaciones moderadas/graves según BILAG hasta la semana 48
    10. Tiempo hasta la exacerbación grave según BILAG hasta la semana 48
    11. Tiempo hasta la exacerbación moderada/grave según BILAG hasta la semana 48
    12. Porcentage de participantes con acontecimiento adverso surgido con el tratamiento (AAST) durante el estudio
    13. Porcentage de participantes con acontecimiento adverso grave surgido con el tratamiento durante el estudio
    14. Porcentage de participantes con acontecimiento adverso de especial interes surgido con el tratamiento durante el estudio
    15. Porcentage de participantes con acontecimiento adverso de monitorización especial surgido con el tratamiento durante el estudio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: Week 24
    2: Week 12
    3, 4, 5, 6, 8, 9: Week 48
    7: From Baseline (Day 1) to Week 48
    10, 11: During Treatment Period up to Week 48
    12, 13, 14, 15: From Baseline (Day 1) until Safety Follow-Up (up to Week 54)
    1: Semana 24
    2: Semana 12
    3, 4, 5, 6, 8, 9: Semana 48
    7: Desde el inicio (Día 1) a la semana 48
    10, 11: Durante el periodo del tratamiendo hasta la semana 48
    12, 13, 14, 15: Desde el inicio (Día 1) hasta un periodo de seguimiento de seguridad (hasta la semana 54)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, immunogenicity
    Tolerabilidad , 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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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
    Bulgaria
    Canada
    Chile
    Colombia
    Czech Republic
    Estonia
    France
    Germany
    Greece
    Hungary
    Italy
    Korea, Republic of
    Lithuania
    Mexico
    Netherlands
    Norway
    Peru
    Philippines
    Poland
    Portugal
    Romania
    Serbia
    Singapore
    Slovakia
    Spain
    Sweden
    Switzerland
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    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 months7
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days10
    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: 25
    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: 25
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 280
    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)
    Study participants who complete the 48-week Treatment Period may be eligible to participate in an open label extension (OLE) study. Study participants who withdraw early from the 48-week Treatment Period or choose not to enter the OLE will be followed up for at least 10 weeks. Safety Follow-up (SFU) after their final dose of study medication.
    Los participantes del estudio que completen el periodo de tratamiento de 48 semanas pueden ser aptos para participar en un estudio de extensión abierta (OLE). Los participantes del estudio que se retiren de forma prematura del periodo de tratamiento de 48 semanas o que decidan no entrar en el OLE se someterán a un seguimiento durante al menos 10 semanas después de la dosis final de la medicación del estudio
    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 Decision2020-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-06-04
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