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    Summary
    EudraCT Number:2019-003407-35
    Sponsor's Protocol Code Number:SL0044
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-01-25
    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 number2019-003407-35
    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
    Étude Randomisée, En Double Aveugle, Contrôlée Par Placebo, À Groupes Parallèles Visant À Évaluer L’efficacité Et La Sécurité D'emploi Du Dapirolizumab Pégol Chez Des Participants À L’étude Présentant Un Lupus Érythémateux Disséminé Modérément À Sévèrement Actif
    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 visant à évaluer l’efficacité et la sécurité d’emploi du dapirolizumab pégol chez des participants à l’étude présentant un lupus érythémateux disséminé modérément à sévèrement actif
    A.3.2Name or abbreviated title of the trial where available
    PHOENYCS FLY
    A.4.1Sponsor's protocol code numberSL0044
    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 codeCDP7657
    D.3.9.3Other descriptive nameDZP
    D.3.9.4EV Substance CodeSUB30739
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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 disséminé (LED)
    E.1.1.1Medical condition in easily understood language
    Systemic lupus erythematosus is a chronic autoimmune inflammatory disease which can present with a persistent active disease course but has more often a relapsing-remitting disease course
    Le lupus érythémateux disséminé (LED) est une maladie inflammatoire auto-immune chronique pouvant présenter une évolution chronique mais dont l’évolution est le plus souvent récurrente-rémittente.
    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 traitement d'appoint par DZP en plus d’un médicament standard à entraîner une amélioration à long terme pertinente sur le plan clinique de l'activité modérée à sévère de la maladie
    E.2.2Secondary objectives of the trial
    Evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (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 traitement d'appoint par DZP en plus d’un médicament standard à:
    -entraîner une amélioration rapide pertinente sur le plan clinique de l'activité modérée à sévère de la maladie
    -entraîner un contrôle à long terme de l'activité de la maladie
    -entraîner et maintenir l’objectif cible du traitement: une faible activité de la maladie avec une faible dose/dose acceptable de corticostéroïdes au fil du temps
    -entraîner une amélioration de l’activité de la maladie mesurée à l’aide d’un score numérique de l’état de la maladie fréquemment utilisé dans la pratique clinique
    -atteindre les composants des critères d’évaluation principaux composites
    - atteindre un autre critère d’évaluation des répondeurs
    -atteindre des critères d’évaluation étayant d’autres critères d’évaluation secondaires clés
    Évaluer l’innocuité et la tolérance du traitement d'appoint par DZP en plus d’un médicament standard
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 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 systemic lupus erythematosus (SLE) or due to an acute worsening of SLE in the scope of frequent flaring/relapsing-remitting SLE despite stable standard of care(SOC) medication defined as:
    a. Diagnosed with SLE at least 24 weeks before the Screening Visit 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)
    ii) Either complement C3 <lower limit of normal (LLN) OR complement C4 <LLN 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. Historical 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 the Screening Visit
    AND
    ◦ SLEDAI-2K without labs ≥4 at Baseline Visit
    e. Receiving the following standard of care (SOC) medications at stable dose:
    ◦ Antimalarial treatment in combination with corticosteroids and/or immunosuppressants or as
    stand-alone treatment if justified
    OR
    ◦ Treatment with corticosteroids and/or immunosuppressants if antimalarial treatment is not appropriate (ie, there is documented intolerance in medical history, documented lack of efficacy, contraindications, or lack of availability)
    - Le participant à l'étude doit être âgé de ≥ 16 ans, à moins que l’âge ne soit limité par la réglementation locale, au moment de la signature du formulaire de consentement éclairé (FCE).
    - Participants à l'étude présentant une activité modérée à sévère de la maladie en raison d'un LED actif persistant ou d'une aggravation aiguë du LED dans le contexte d'un LED récurrentrémittent/ associé à des poussées fréquentes malgré un traitement standard stable définis comme suit :
    a. Avoir reçu un diagnostic de LED au moins 24 semaines avant la visite de sélection établi par un médecin qualifié
    b. Avoir un LED classé selon les critères de classification du LED de 2019 de l’European League Against Rheumatism/American College of Rheumatology (EULAR/ACR)
    c. Présenter des résultats sérologiques étayant un LED lors de la sélection démontrés par au moins un des éléments suivants :
    i) Présence d'anticorps anti-ADNdb (définie comme la présence d'anticorps anti-ADNdb déterminée par le laboratoire central)
    ii) Taux de complément C3 < à la limite inférieure de la normale (LIN) OU taux de complément C4 < LIN mesuré par le laboratoire central
    iii) Présence d’anticorps antinucléaires avec un titre d’au moins 1 : 80 confirmée par le laboratoire central en association avec la présence d’au moins un des auto-anticorps typiques du LED suivants :
    1. Présence d’anticorps anti-Smith (anti-Sm) (laboratoire central)
    2. Présence d’auto-anticorps anti-syndrome de Sjögren de type A (anti-SSA) (Ro)/d’auto-anticorps anti-syndrome de Sjögren de type B (anti-SSB) (La) (laboratoire central)
    3. Données historiques confirmant la présence d’anticorps anti-ADNdb
    d. Présenter un LED modérément à sévèrement actif défini comme suit :
    ◦ Grade B selon le score BILAG de 2004 pour ≥ 2 systèmes organiques et/ou grade A selon le score BILAG de 2004 pour ≥ 1 système organique lors de la sélection et de la visite d’inclusion
    ET
    ◦ Score SLEDAI-2K ≥ 6 lors de la visite de sélection
    ET
    ◦ Score SLEDAI-2K sans les valeurs biologiques ≥ 4 lors de la visite d’inclusion
    e. Recevoir les médicaments standards suivants à une dose stable :
    ◦ Traitement antipaludique en association avec des corticostéroïdes et/ou des immunosuppresseurs ou en tant que traitement indépendant si cela est justifié
    OU
    ◦ Traitement par corticostéroïdes et/ou immunosuppresseurs si un traitement antipaludique n'est pas approprié (c.-à-d., en présence d’une intolérance documentée dans les antécédents médicaux, d’une absence d'efficacité documentée, de contreindications ou d’un manque de disponibilité)
    E.4Principal exclusion criteria
    - Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric 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. This includes systemic reactions due to latex allergy
    - Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ (after complete resection [eg, curettage, electrodesiccation] not later than 4 weeks prior to the Screening Visit [V1]), basal cell carcinoma, or dermatological squamous cell carcinoma
    - Study participant 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 a mixed connective tissue disease, scleroderma, and/or overlap syndrome of these diseases with SLE
    - Study participant has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or during the study
    - Study participant has clinically significant active or latent infection
    - Study participant had a reactivated latent infection (eg, cytomegalovirus, herpes simplex virus, or herpes zoster infection) or opportunistic infection (including but not limited to, pneumocystis, cytomegalovirus, or severe herpes zoster 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 used the prohibited medications defined in the Protocol
    - Study participant has previously been randomized within this study or has previously been assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating DZP
    - Study participant has participated in another study of an investigational medicinal product (IMP) within the previous 12 weeks or 5 half-lives of the 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 (eGFR) <30 mL/min/1.73m2, or serum creatinine >2.5 mg/dL, or participant has proteinuria >3g/day, or protein:creatinine ratio >340 mg/mmol at the Screening Visit
    - Le participant à l’étude présente un problème médical ou psychiatrique (y compris des troubles dus à un LED neuropsychiatrique) qui, selon l’investigateur, pourrait le mettre en danger ou compromettre sa capacité à participer à cette étude.
    -Le participant à l'étude a des antécédents de réaction anaphylactique à une administration parentérale d'agents de contraste, de protéines humaines ou murines ou d'anticorps monoclonaux. Cela inclut des réactions systémiques dues à une allergie au latex.
    - Le participant à l'étude a des antécédents de tumeur maligne, à l'exception des cancers traités suivants : carcinome cervical in situ (après résection complète [par exemple, curetage, électrodessiccation] au plus tard 4 semaines avant la visite de sélection [V1]), carcinome basocellulaire ou carcinome épidermoïde de la peau
    -Le participant à l'étude présente un risque accru d'événements thromboemboliques en raison d’une maladie cardiaque en cours ou d’un dispositif médical, y compris, mais sans s'y limiter, une greffe vasculaire, une cardiopathie valvulaire, une fibrillation auriculaire ou un trouble du rythme cardiaque.
    - Le participant à l'étude est atteint d’une maladie mixte du tissu conjonctif, d’une sclérodermie et/ou d’un syndrome de chevauchement de ces maladies en plus du LED.
    -Le participant à l'étude présente des signes d'infection par le virus de l'immunodéficience humaine (VIH), d'agammaglobulinémies, de déficits en lymphocytes T ou d'infection par le virus T-lymphotrope humain 1 à tout moment avant ou pendant l'étude.
    - Le participant à l'étude a une infection active ou latente significative sur le plan clinique
    -Le participant à l'étude a présenté une réactivation d’une infection latente (p. ex., infection à cytomégalovirus, par le virus de l'herpès simplex ou par le virus de l’herpès zoster) ou une infection opportuniste (y compris, mais sans s'y limiter, une pneumocystose, une infection sévère à cytomégalovirus ou par le virus de l’herpès zoster) au cours des 12 semaines
    précédant la première perfusion du médicament à l'étude (visite 2) ou reçoit actuellement un traitement suppresseur pour traiter une infection opportuniste
    - Les participants à l'étude ayant reçu des vaccins vivants/vivants atténués au cours des 6 semaines précédant la première perfusion du médicament à l'étude
    -Le participant à l’étude a utilisé des médicaments interdits énumérés dans le protocole
    -Le participant à l'étude a déjà été randomisé dans le cadre de cette étude ou a déjà été assigné à un traitement par DZP dans une étude évaluant le DZP.
    -Le participant à l'étude a participé à une autre étude évaluant un ME (et/ou un dispositif expérimental) au cours des 12 semaines précédentes ou des 5 demi-vies du ME, selon la durée la plus longue (voir le tableau 6-7 du protocole), ou participe actuellement à une autre étude évaluant un ME.
    -Le participant à l'étude est atteint d’insuffisance rénale chronique de stade 4, se manifestant par un débit de filtration glomérulaire estimé (DFGe) < 30 ml/min/1,73 m2, ou un taux de créatinine sérique > 2,5 mg/dl, ou le participant présente une protéinurie > 3 g/jour, ou un rapport protéine/créatinine > 340 mg/mmol lors de la visite de sélection (V1).
    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 2004 improvement without worsening at Week 48
    7. Change from Baseline in PGA at Week 48
    8. Achievement of SRI 4 response at Week 48
    9. Achievement of prevention of moderate/severe BILAG flares (moderate/severe BILAG flarefree) 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 de résultats en matière de prévention des poussées sévères selon le score BILAG (absence de poussées sévères selon le score BILAG) jusqu'à la semaine 48
    4. Obtention d’un état de faible activité du lupus (LLDAS) lors de ≥ 50 % des visites réalisées après l’inclusion jusqu’à la semaine 48
    5. Changement du score SLEDAI-2K entre l’inclusion et la semaine 48
    6. Obtention d’une amélioration du score BILAG de 2004 sans aggravation à la semaine 48
    7. Changement du score PGA entre l’inclusion et la semaine 48
    8. Obtention d’une réponse SRI-4 à la semaine 48
    9. Obtention de résultats en matière de prévention des poussées modérés/sévères selon le score BILAG (sans poussées
    modérées/sévères selon le score BILAG) jusqu'à la semaine 48
    10. Temps écoulé jusqu’à la survenue d’une poussée sévère selon le score BILAG jusqu’à la semaine 48
    11. Temps écoulé jusqu’à la survenue d’une poussée modérée/sévère selon le score BILAG jusqu’à la semaine 48
    12. Pourcentage de patients avec EIAT pendant l'étude
    13. Pourcentage de patients avec EIAT graves pendant l'étude
    14. Pourcentage de patients avec EIAT présentant un intérêt particulier pendant l'étude
    15. Pourcentage de patients avec EIAT nécessitant une surveillance particulière pendant l'étude
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: Week 24
    2: Week 12
    3, 4: During Treatment Period up to Week 48
    5: From Baseline (Day 1) to Week 48
    6: Week 48
    7: From Baseline (Day 1) to Week 48
    8: Week 48
    9, 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: pendant la période de traitement jusqu'à la semaine 48
    5: à partir de l’inclusion (jour 1) jusqu'à la semaine 48
    6: Semaine 48
    7: à partir de l’inclusion (jour 1) jusqu'à la semaine 48
    8: Semaine 48
    9, 10, 11: pendant la période de traitement jusqu'à la semaine 48
    12, 13, 14, 15:à partir de l’inclusion (jour 1) jusqu'à la suivi de l’innocuité (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
    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
    Austria
    Belgium
    Bulgaria
    Canada
    China
    Czechia
    Denmark
    France
    Germany
    Greece
    Hong Kong
    Italy
    Japan
    Poland
    Portugal
    Serbia
    Spain
    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
    Dernière visite 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 months2
    E.8.9.1In the Member State concerned days27
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days27
    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 Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    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 Decision2022-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-01
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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