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    Summary
    EudraCT Number:2019-003406-27
    Sponsor's Protocol Code Number:SL0043
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-12-22
    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 ConcernedFrance - ANSM
    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
    Essai randomisé multicentrique en double insu contre placebo évaluant l'efficacité et la tolérance du dapirolizupab pegol chez des participants avec un lupus érythémateux systémique avec activité modérée à sévère
    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
    Étude randomisée, contrôlée contre placebo, évaluant l’efficacité et la tolérance du dapirolizumab pegol chez des participants à l’étude présentant un lupus érythémateux systémique modérément à sévèrement actif
    A.3.2Name or abbreviated title of the trial where available
    PHOENYCS GO
    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 érythémateux systémique
    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.
    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
    Évaluer la capacité du dapirolizumab pegol (DZP) en traitement adjuvant à un traitement de référence à parvenir à une amélioration à long terme cliniquement significative de l’activité modérée à sévère de la maladie
    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
    Évaluer la capacité du DZP en traitement adjuvant à un traitement de référence :
    - à une amélioration à long terme cliniquement significative de l’activité modérée à sévère de la maladie
    - au contrôle à long terme de la maladie
    - à maintenir un objectif de traitement à la cible : faible activité de la maladie avec une dose faible/acceptable de corticoïdes avec le temps
    - à permettre une amélioration de l’activité de la maladie, d’après la mesure du score numérique d’état de la maladie généralement utilisé en pratique clinique.
    - à atteindre des composantes des critères d’évaluation principaux composites
    - à atteindre d’autres critères d’évaluation des répondeurs
    - à atteindre des critères d’évaluation corroborant d’autres critères secondaires fondamentaux
    Évaluer la tolérance et la sécurité d’emploi du DZP en traitement adjuvant à un traitement de référence
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Rescreening will be allowed once during the study in case there is new evidence for an inclusion criterion that was not fulfilled at the first screening or in case a study participant no longer meets an exclusion criterion or screening period exceeded the maximum duration due to delays in screening processes
    -Study participant must be ≥16 years of age, unless restricted by local regulation, at the time of signing the Informed Consent form (ICF)
    - 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 Screening Visit (Visit 1) 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 at Screening as demonstrated by at least 1 of the following:
    i) Evidence for anti-dsDNA (defined as evidence for anti-dsDNA antibodies in central laboratory at Screening)
    ii) Either complement C3 < lower limit of normal (LLN) OR complement C4 <LLN OR elevated erythrocyte-bound complement C4d (where available) 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 medication 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
    La re-sélection sera autorisé une fois au cours de l'étude en cas de nouvelles preuves d'un critère d'inclusion qui n'a pas été rempli lors de la première sélection ou dans le cas où un participant à l'étude ne répond plus à un critère d'exclusion ou si la période de dépistage a dépassé la durée maximale en raison de retards dans processus de sélection
    - Le (la) participant(e) à l’étude doit être âgé(e) de ≥ 16 ans, sauf restriction exigée par la réglementation locale, au moment de la signature du formulaire de consentement éclairé (FCE).
    - Participants dont l’activité de la maladie est modérée à sévère en raison d’un LES actif persistant ou en raison d’une aggravation aiguë du LES dans le cadre d’un LES caractérisé par des épisodes fréquents de poussées/récidives-rémissions malgré un traitement de référence stable défini selon les critères suivants : Diagnostic de LES établi par un médecin qualifié (par exemple,rhumatologue, spécialiste en médecine interne, néphrologue ou dermatologue) au moins 24 semaines avant l’entrée dans l’étude :
    a. Diagnostic de LES au moins 24 semaines avant la visite de sélection (Visite 1), établi par un médecin qualifié (par exemple, rhumatologue, spécialiste de médecine interne, néphrologue ou dermatologue)
    b. Classification selon les critères EULAR/ACR (European League Against Rheumatism [Ligue européenne contre le rhumatisme]/American College of Rheumatology [Collège américain de rhumatologie]) 2019 relatifs au LES
    c. Présence de signes sérologiques de LES à la sélection, démontrée par au moins 1 des critères suivants : i) Présence d’anti-ADNdb (définie comme la mise en évidence d’anticorps anti-ADNdb par le laboratoire central)
    ii) Taux de complément C3 < limite inférieure de la normale (LIN) OU complément C4 < LIN OU taux élevé de complément C4d lié aux érythrocytes (si disponible), d’après la mesure du laboratoire central
    iii) Anticorps antinucléaires avec un titre d’au moins 1:80 confirmé par le laboratoire central en association à la mise en évidence d’au moins 1 des auto-anticorps suivants typiques du LES :
    1. Anticorps anti-Smith (anti-Sm) (laboratoire central)
    2. Auto-anticorps anti-syndrome de Sjögren A (Anti-SSA) (Ro)/anti-syndrome de Sjögren B (anti-SSB) (La) (laboratoire central)
    3. Données antérieures montrant la présence d’anticorps anti-ADNdb
    d. Maladie modérément à sévèrement active définie selon les critères suivants :
    - Indice 2004 d’activité de la maladie du Groupe d’évaluation du lupus des îles britanniques (BILAG 2004, British Isles Lupus Assessment Group Disease Activity Index 2004) de Grade B dans ≥ 2 systèmes d’organes et/ou BILAG 2004 de Grade A dans ≥ 1 système d’organes lors des visites de sélection et d’inclusion ET
    - SLEDAI-2K ≥ 6 à la visite de sélection ET
    - SLEDAI-2K sans paramètres biologiques ≥ 4 à la visite d’inclusion
    e. Traitement de référence en cours suivant à dose stable :
    ◦ Traitement antipaludique en association à des corticoïdes et/ou des immunosuppresseurs ou en traitement seul si justifié
    OU
    ◦ Traitement par corticoïdes et/ou immunosuppresseurs si le traitement antipaludique n’est pas possible
    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 has an increased risk for thromboembolic events due to an ongoing heart disease or due to a medical device, including but not limited to vascular graft, valvular heart disease, atrial fibrillation, or a heart rhythm disorder
    - 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 a reactivated latent or opportunistic infection within 12 weeks prior to the first study medication infusion (Visit 2), or is currently receiving suppressive therapy for an opportunistic infection
    - 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
    - Study participant has previously been randomized within this study or participant has previously been assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating 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 stage 4, manifested by estimated glomerular filtration rate <30 mL/min/1.73 m2, or serum creatinine >2.5 mg/dL, or participant has proteinuria >3 g/day, or protein: creatinine ratio >340 mg/mmol at the Screening Visit
    - Pathologie médicale ou psychiatrique significative (y compris pathologies dues à un LES neuropsychiatrique), susceptible, d’après l’investigateur, de mettre en péril le participant/la participante ou de compromettre sa capacité à participer à cette étude. Cette catégorie inclut les participants à l’étude présentant une pathologie menaçant le pronostic vital.
    - Antécédents de réaction anaphylactique à l’administration parentérale de produits de contraste, de protéines humaines ou murines ou d’anticorps monoclonaux.
    - Antécédents de cancer, sauf les cancers traités suivants : carcinome in situ du col de l’utérus, carcinome basocellulaire ou épithélioma malpighien spinocellulaire dermatologique.
    - Risque accru d’événements thrombo-emboliques dus à une cardiopathie en cours ou dus à un dispositif médical, y compris notamment prothèse vasculaire, valvulopathie, fibrillation auriculaire, ou trouble du rythme cardiaque.
    - Mise en évidence d’une infection par le virus de l’immunodéficience humaine, d’une agammaglobulinémie, de déficits en lymphocytes T ou d’infection par le virus T-lymphotropique humain 1
    - Antécédents d’infection latente réactivée ou infection opportuniste au cours des 12 semaines précédant la première perfusion de médicament à l’étude (Visite 2), ou traitement suppresseur en cours pour une infection opportuniste.
    Les participants à l’étude ayant reçu un vaccin vivant/vivant atténué au cours des 6 semaines précédant la première perfusion de médicament à l’étude
    - Présence d’une connectivite mixte, d’une sclérodermie et/ou d’un syndrome de chevauchement de ces pathologies avec le lupus érythémateux systémique.
    - Utilisation des médicaments interdits mentionnés dans le protocole
    - Antécédents de randomisation dans la présente étude ou affectation antérieure à un traitement par DZP dans une étude évaluant le DZP.
    - Antécédents de participation à une autre étude évaluant un médicament expérimental (et/ou un dispositif expérimental) au cours des 12 semaines précédentes ou 5 demi-vies du ME selon la durée la plus longue ou participation en cours à une autre étude sur un ME.
    - Insuffisance rénale chronique de stade 4, se manifestant par un débit estimé de filtration glomérulaire (DFGe) < 30 ml/min/1,73 m2, ou une créatininémie > 2,5 mg/dl, ou le participant à une protéinurie > 3 g/jour ou un rapport protéines/créatinine > 340 mg/mmol à la visite de sélection
    E.5 End points
    E.5.1Primary end point(s)
    Achievement of BICLA response at Week 48
    Obtention d’une réponse BICLA à la Semaine 48
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 48
    Semaine 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 (severe BILAG flare-free) 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 (moderate/severe BILAG flare-free) 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. Obtention d’une réponse BICLA à la Semaine 24
    2. Obtention d’une réponse BICLA à la Semaine 12
    3. Obtention d’une prévention des poussées BILAG sévères (sans poussées BILAG sévères) jusqu’à la Semaine 48
    4. Atteinte d’un statut de faible activité de la maladie lupique (LLDAS) dans ≥ 50 % des visites après l’inclusion jusqu’à la Semaine 48
    5. Modifications du score SLEDAI-2K à la Semaine 48 par rapport aux valeurs initiales
    6. Obtention d’une amélioration BILAG sans aggravation à la Semaine 48
    7. Modifications du score PGA à la Semaine 48 par rapport aux valeurs initiales
    8. Obtention d’une réponse SRI4 à la Semaine 48
    9. Obtention d’une prévention de poussées BILAG modérées/sévères (sans poussées BILAG modérées/sévères) jusqu’à la Semaine 48
    10. Délai avant la survenue de poussées BILAG sévères jusqu’à la Semaine 48
    11. Délai avant la survenue de poussées BILAG modérées/sévères jusqu’à la Semaine 48
    12. Pourcentage de participants ayant eu des événements indésirables apparaissant sous traitement au cours de l'étude
    13. Pourcentage de participants ayant eu des événements indésirables graves apparaissant sous traitement au cours de l'étude
    14. Pourcentage de participants présentant des effets indésirables survenus pendant le traitement et présentant un intérêt particulier au cours de l'étude
    15. Pourcentage de participants ayant présenté des événements indésirables survenus pendant le traitement et faisant l'objet d'une surveillance spéciale pendant l'étude
    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: Semaine 24
    2: Semaine 12
    3, 4, 5, 6, 8, 9: Semaine 48
    7: Du niveau de base (Jour 1) à la Semaine 48
    10, 11: Durant la période de traitement jusqu'à la Semaine 48
    12, 13, 14, 15: Du niveau de base (Jour 1) jusqu'à la visite de suivie (jusqu'à la Semaine 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
    Tolérance, immunogénicité
    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 concerned6
    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
    Canada
    Chile
    Colombia
    Korea, Republic of
    Mexico
    Peru
    Philippines
    Serbia
    Taiwan
    United States
    Austria
    Belgium
    Bulgaria
    Czechia
    Denmark
    France
    Germany
    Greece
    Hungary
    Italy
    Poland
    Portugal
    Romania
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Dernière visite du dernier patient
    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 months6
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days21
    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 state25
    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.
    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 Decision2021-03-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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