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    Summary
    EudraCT Number:2021-006378-22
    Sponsor's Protocol Code Number:230LE306
    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:2023-01-13
    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 number2021-006378-22
    A.3Full title of the trial
    A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 in Adult Participants with Active Systemic Lupus Erythematosus
    Estudio de extensión a largo plazo en fase III, multicéntrico, aleatorizado y de dosis ciega para evaluar la eficacia y la seguridad de BIIB059 de forma continua en participantes adultos con lupus eritematoso sistémico (LES) activo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Continuous Safety and Efficacy of BIIB059 in Adults with Active Systemic Lupus Erythematosus
    Estudio para evaluar a la eficacia y la seguridad de BIIB059 en adultos con Lupus Eritematoso Sistémico (LES) activo
    A.3.2Name or abbreviated title of the trial where available
    EMERALD
    A.4.1Sponsor's protocol code number230LE306
    A.5.4Other Identifiers
    Name:IND/IDE NumberNumber:117288
    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 SponsorBiogen Idec Research Limited
    B.1.3.4CountryUnited Kingdom
    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 supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointN/A
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+3491 310 7110
    B.5.6E-mailclinicaltrials@biogen.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 nameNot applicable
    D.3.2Product code BIIB059
    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 INNBIIB059
    D.3.9.2Current sponsor codeBIIB059
    D.3.9.4EV Substance CodeSUB208560
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant, fully humanized, anti-BDCA2 IgG1 monoclonal antibody expressed in a CHO cell line.
    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
    Systemic Lupus Erythematosus
    Lupus Eritematoso Sistémico
    E.1.1.1Medical condition in easily understood language
    Lupus
    Lupus
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025139
    E.1.2Term Lupus erythematosus systemic
    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
    The Primary Objective of this Clinical Trial is to evaluate the long-term safety and tolerability of BIIB059 in participants with active SLE.
    El objetivo principal de este ensayo clínico es evaluar la seguridad y tolerabilidad a largo plazo de BIIB059 en participantes con LES activo.
    E.2.2Secondary objectives of the trial
    The Secondary Objectives of this Clinical Trial are:
    - to evaluate the long-term effect of BIIB059 on disease activity in participants with SLE
    - to evaluate the long-term effect of BIIB059 in participants with SLE in maintaining low disease activity
    - to evaluate the effect of BIIB059 in participants with active SLE in preventing irreversible organ damage
    - to assess long-term use of OCS6 with participants receiving BIIB059 treatment
    - to assess the impact of BIIB059 on participant-reported HRQoL, symptoms and impacts of SLE
    - to evaluate long-term effect of BIIB059 on laboratory parameters
    - to evaluate immunogenicity of BIIB059
    Los objetivos secundarios de este Ensayo Clinico son:
    - Evaluar el efecto a largo plazo de BIIB059 sobre la actividad de la enfermedad en participantes con LES.
    - Evaluar el efecto a largo plazo de BIIB059 en participantes con LES en el mantenimiento de una actividad baja de la enfermedad.
    - Evaluar el efecto de BIIB059 en participantes con LES activo en la prevención de daños orgánicos irreversibles.
    - Evaluar el uso a largo plazo de CO6 en los participantes que reciben tratamiento con BIIB059.
    - Evaluar el impacto de BIIB059 en la CdVRS, los síntomas y las repercusiones del LES notificados por los participantes.
    - Evaluar el efecto a largo plazo de BIIB059 sobre los parámetros analíticos.
    - Evaluar la inmunogenia de BIIB059. Incidencia de anticuerpos contra BIIB059.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    1. Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 and 230LE304) on study treatments with either BIIB059 or placebo to Week 48 and attended the last study assessment visit at Week 52.
    2. Ability of the participant and/or his/her legally authorized representative (e.g., parent, spouse, or legal guardian), as appropriate and applicable, to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations.
    3. All women of childbearing potential must agree to practice effective contraception during the study and for 126 days (18 weeks) after their last dose of study treatment. In addition, participants should not donate eggs during the study and for at least 126 days (18 weeks) after their last dose of study treatment. Where applicable, if not previously confirmed in the parent Phase 3 study, postmenopausal status must be confirmed as follows: for women ≤ 55 years of age, 52 continuous weeks of natural (spontaneous) amenorrhea without an alternative medical cause and a serum FSH level ≥ 40 mIU/mL; for women > 55 years of age, 52 continuous weeks of natural (spontaneous) amenorrhea without an alternative medical cause and a serum FSH level ≥ 40 mIU/mL, or at least 5 continuous years of natural (spontaneous) amenorrhea without an alternative medical cause.
    Criterios de inclusión principales:
    1. Participantes que completaron una de las 52 semanas de los estudios originales en fase III, doble ciego y controlados con placebo (230LE303 y 230LE304) y que recibieron los tratamientos del estudio con BIIB059 o placebo hasta la semana 48 y acudieron a la última visita de evaluación del estudio en la semana 52.
    2. Capacidad del participante o su representante legal autorizado (p. ej., progenitor, cónyuge o tutor legal), cuando proceda y según corresponda, para comprender el fin y los riesgos del estudio, para proporcionar el consentimiento informado y para autorizar el uso de la información médica confidencial de acuerdo con la normativa nacional y local sobre privacidad.
    3. Todas las mujeres en edad fértil deben acceder a utilizar métodos anticonceptivos eficaces durante el estudio y durante 126 días (18 semanas) después de su última dosis del tratamiento del estudio. Además, las participantes no deben donar óvulos durante el estudio ni tampoco durante al menos 126 días (18 semanas) tras la última dosis del tratamiento del estudio. Cuando proceda, si no se ha confirmado previamente en el estudio original en fase III, el estado posmenopáusico debe confirmarse de la siguiente manera: en el caso de las mujeres ≤55 años de edad, 52 semanas continuas de amenorrea natural (espontánea) sin una causa médica alternativa y un nivel de hormona foliculoestimulante (FSH) sérico ≥40 mUI/ml; en el caso de las mujeres >55 años de edad, 52 semanas continuas de amenorrea natural (espontánea) sin una causa médica alternativa y un nivel de FSH sérico ≥40 mUI/ml o al menos 5 años continuos de amenorrea natural (espontánea) sin una causa médica alternativa.
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    1. Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52).
    2. Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52-week treatment period).
    3. Participants who have developed any other medical diseases, conditions, or abnormalities, rendering their participation in the LTE study unsuitable in the opinion of the Investigator.
    4. Participants who developed moderate-to-severe worsening of organ-specific lupus manifestations that would require a change in immunosuppressive therapy.
    5. Use of prohibited concurrent medication or therapy during the parent Phase 3 studies.
    6. Immunization with live or live-attenuated vaccines within 4 weeks prior to Baseline Visit.
    7. Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies.
    8. Female participants who are pregnant, currently breastfeeding, or planning to become pregnant during the study and for 126 days (18 weeks) after the last dose of study treatment.
    9. Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered (participation in observational registries is allowed).
    10. Inability to comply with study requirements.
    11. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the participant unsuitable for enrollment.
    Criterios de exclusión principales:
    1. Pacientes que interrumpieron el tratamiento de los estudios originales en fase III de forma anticipada (participantes que interrumpieron el tratamiento del estudio antes de la semana 52).
    2. Pacientes que interrumpieron los estudios originales en fase III de forma anticipada (participantes que se retiraron del estudio y no completaron el periodo de tratamiento de 52 semanas).
    3. Participantes que hayan desarrollado cualquier otra enfermedad, afección o anomalía médica que haga que su participación en el estudio de ELP no sea apta en opinión del investigador.
    4. Participantes que presentaron un empeoramiento de moderado a grave de las manifestaciones de lupus específicas de los órganos que requiriera un cambio en el tratamiento con inmunodepresores.
    5. Uso de medicamentos o tratamientos concomitantes prohibidos durante los estudios originales en fase III.
    6. Inmunización con vacunas elaboradas con microbios vivos o atenuadas en las 4 semanas anteriores a la visita inicial.
    7. Uso de otros fármacos en investigación o fármacos de naturaleza extraoficial utilizados para tratar el LES, el lupus cutáneo o la nefritis lúpica durante los estudios originales en fase III.
    8. Mujeres participantes que estén embarazadas, en periodo de lactancia o que tengan previsto quedarse embarazadas durante el estudio y durante 126 días (18 semanas) después de la última dosis del tratamiento del estudio.
    9. Inscripción actual o previsión de inscribirse en cualquier estudio clínico intervencionista en el que se administre un tratamiento en investigación o autorizado para su uso en investigación (la participación en registros observacionales está permitida).
    10. Incapacidad para cumplir con los requisitos del estudio.
    11. Otra razón no especificada que, en opinión del investigador o del promotor, haga que el participante no sea apto para la inscripción.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints:
    Incidence of TEAEs -
    Number of Participants with Treatment Emergent Adverse Events (TEAEs) up to Week 180

    Incidence of SAEs -
    Number of Participants with Serious Adverse Events (SAEs) up to Week 180
    Criterios de valoración principales:
    Incidencia de AAST:
    Número de participantes con acontecimientos adversos surgidos durante el tratamiento (AAST) hasta la semana 180.

    Incidencia de AAG:
    Número de participantes con acontecimientos adversos graves (AAG) hasta la semana 180.
    E.5.1.1Timepoint(s) of evaluation of this end point
    All endpoints measured within TimeFrame as mentioned in point E.5.1 Primary end point(s)
    Todos los criterios de valoración medidos dentro del plazo mencionado en el punto E.5.1 Criterios de valoración principales.
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    - Percentage of Participants who Achieved an Systemic Lupus Erythematosus Responder Index (SRI)-4 Response up to Week 180
    - Percentage of Participants who Achieved a Joint-50 Response up to Week 180
    - Percentage of Participants who Achieved Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50, CLASI-70, and CLASI-90 Response up to Week 180
    - Percentage of Participants who Achieved a British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) Response up to Week 180
    - Annualized Severe Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI) Flare Rate up to Week 156
    - Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS) up to Week 180
    - Duration of Sustained LLDAS as Defined by the Number of Visits in LLDAS up to Week 180
    - Annual Change From Baseline Value From the Parent Phase 3 Studies in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) Score up to Week 156
    - Cumulative Exposure to OCS Over Time up to Week 156
    - Percentage of Participants With OCS ≤7.5 mg up to Week 156
    - Percentage of Participants With OCS ≤5 mg up to Week 156
    - Change From Baseline in Lupus-Specific Health-Related Quality-Of-Life (LupusQoL) Score up to Week 156
    - Change From Baseline in Short Form Health Survey-36 (SF-36) (Acute Version) Score up to Week 156
    - Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score up to Week 156
    - Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score up to Week 156
    - Change From Baseline in Work Productivity and Activity Impairment (WPAI):Lupus Score up to Week 156
    - Change from Baseline in Patient Global Assessment (PtGA) Score up to Week 156
    - Number of Participants with Clinically Relevant Abnormalities in Standard Laboratory Parameters up to Week 180
    - Number of Participants with Clinically Relevant Abnormalities in Electrocardiogram (ECGs) Results up to Week 156
    - Number of Participants with Antibodies to BIIB059 up to Week 180
    Criterios de valoración secundarios:
    - Porcentaje de participantes que lograron una respuesta en relación con el Índice de sujeto con respuesta del lupus eritematoso sistémico (SRI)-4 hasta la semana 180.
    - Porcentaje de participantes que lograron una respuesta de Joint-50 hasta la semana 180.
    - Porcentaje de participantes que lograron una respuesta en relación con el Índice de la intensidad y el área del lupus eritematoso cutáneo (CLASI)-50, CLASI-70 y CLASI-90 hasta la semana 180.
    - Porcentaje de participantes que lograron una respuesta de la evaluación del lupus combinada basada en el grupo de evaluación del lupus de las Islas Británicas (BICLA) hasta la semana 180.
    - Tasa anualizada de exacerbaciones graves del índice de exacerbaciones del índice de actividad del lupus eritematoso sistémico (SFI) y de la evaluación nacional de seguridad de los estrógenos en el lupus eritematoso sistémico hasta la semana 156.
    - Porcentaje de tiempo pasado en el estado de actividad baja del lupus (LLDAS) hasta la semana 180.
    - Duración del LLDAS sostenido, definido por el número de visitas en LLDAS hasta la semana 180.
    - Cambio anual con respecto al valor inicial de los estudios originales en fase III en la puntuación del índice de daño de las Clínicas Colaboradoras Internacionales de Lupus Sistémico/del Colegio Estadounidense de Reumatología (SDI) hasta la semana 156.
    - Exposición acumulada a CO a lo largo del tiempo hasta la semana 156.
    - Porcentaje de participantes con CO ≤7,5 mg hasta la semana 156.
    - Porcentaje de participantes con CO ≤5 mg hasta la semana 156.
    - Cambio con respecto al inicio en la puntuación de la calidad de vida relacionada con la salud específica del lupus (LupusQoL) hasta la semana 156.
    - Cambio con respecto al inicio en la puntuación de la encuesta de salud resumido de 36 ítems (SF-36) (versión aguda) hasta la semana 156.
    - Cambio con respecto al inicio en la puntuación de la Escala de evaluación funcional del tratamiento contra las enfermedades crónicas (FACIT)-fatiga hasta la semana 156.
    - Cambio con respecto al inicio en la puntuación del cuestionario de salud del paciente de 9 preguntas (PHQ 9) hasta la semana 156.
    - Cambio con respecto al inicio en la puntuación del cuestionario sobre el deterioro de la actividad y la productividad laborales (WPAI): lupus hasta la semana 156.
    - Cambio con respecto al inicio en la puntuación de la evaluación global del paciente (PtGA) hasta la semana 156.
    - Número de participantes con anomalías clínicamente relevantes en los parámetros analíticos habituales hasta la semana 180.
    - Número de participantes con anomalías clínicamente relevantes en los resultados del electrocardiograma (ECG) hasta la semana 156.
    - Número de participantes con anticuerpos contra BIIB059 hasta la semana 180.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All endpoints measured within TimeFrame as mentioned in point E.5.2 Secondary end point(s)
    Todos los criterios de valoración medidos en el plazo mencionado en el punto E.5.2 Criterios de valoración secundarios.
    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 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
    long-term tolerability
    long-term effect on disease activity
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Brazil
    Canada
    Chile
    China
    Israel
    Japan
    Korea, Republic of
    Mexico
    Peru
    Philippines
    Taiwan
    United States
    France
    Poland
    Sweden
    Bulgaria
    Netherlands
    Romania
    Spain
    Czechia
    Germany
    Greece
    Italy
    Belgium
    Hungary
    United Kingdom
    Serbia
    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 EOS is the last visit for the last participant for the final collection of data for the primary outcome.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months3
    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: 844
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 195
    F.4.2.2In the whole clinical trial 864
    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)
    Participants who successfully complete the 156-week treatment period with assigned study treatments are treatment period completers, and they will be encouraged to enter the 24 week SFU. Participants who discontinue assigned study treatments before Week 152 are early treatment terminators, and they will be encouraged to complete all study assessments for the ET Visit as soon as possible but within 4 weeks of discontinuation of study treatment.
    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 Decision2023-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-07
    P. End of Trial
    P.End of Trial StatusOngoing
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