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    Summary
    EudraCT Number:2017-002322-20
    Sponsor's Protocol Code Number:PA0010
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-03-25
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-002322-20
    A.3Full title of the trial
    A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ACTIVE REFERENCE (ADALIMUMAB) STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN THE TREATMENT OF SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS
    Etude de Phase 3, Multicentrique, randomisée, en double insu, contrôlée contre placebo et traitement de référence actif (adalimumab), évaluant l’efficacité et la tolérance du bimékizumab chez des patients présentant un rhumatisme psoriasique actif
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the efficacy and safety of bimekizumab in the treatment of subjects with active psoriatic arthritis
    Etude évaluant l’efficacité et la tolérance du bimékizumab chez des patients présentant un rhumatisme psoriasique actif
    A.3.2Name or abbreviated title of the trial where available
    BE OPTIMAL
    A.4.1Sponsor's protocol code numberPA0010
    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 SPRL
    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 SPRL
    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 nameBimekizumab
    D.3.2Product code UCB4940
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNBIMEKIZUMAB
    D.3.9.1CAS number 1418205-77-2
    D.3.9.2Current sponsor codeUCB4940
    D.3.9.4EV Substance CodeSUB130157
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Humira®
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAdalimumab
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeSUB20016
    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 injection in pre-filled syringe
    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
    Psoriatic Arthritis
    Rhumatisme psoriasique
    E.1.1.1Medical condition in easily understood language
    Psoriatic arthritis is a type of inflammatory arthritis that can cause swelling, stiffness and pain in the joints.
    Le rhumatisme psoriasique est une forme d'arthrite inflammatoire qui peut causer un gonflement, une raideur ou une douleur au niveau des articulations.
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate the clinical efficacy of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of subjects with active Psoriatic Arthritis (PsA), as assessed by the American College of Rheumatology 50% Improvement (ACR50) response
    Démontrer l’efficacité clinique du bimekizumab administré par voie sous-cutanée (sc) par rapport au placebo dans le traitement des patients atteints de rhumatisme psoriasique actif (RPs), évalués en fonction de la réponse ACR50 (American College of Rheumatology)
    E.2.2Secondary objectives of the trial
    -Assess the efficacy of bimekizumab compared with placebo
    -Assess the safety and tolerability of bimekizumab
    -Assess the impact of bimekizumab on patient-reported quality of life
    -Assess the impact of bimekizumab on skin psoriasis (PSO) in the subgroup of affected subjects at Baseline
    -Assess the impact of bimekizumab on functional improvement
    -Assess the impact of bimekizumab on radiographic changes in the hands and feet
    -Assess the impact of bimekizumab on extra-articular disease manifestations (dactylitis, enthesitis)
    -Évaluer l’efficacité du bimekizumab par rapport au placebo
    -Évaluer l’innocuité et la tolérance du bimekizumab
    -Évaluer l’impact du bimekizumab sur la qualité de vie rapportée par le patient
    -Évaluer l’impact du bimekizumab sur le psoriasis (PSO) cutané dans le sous-groupe de patients affectés à l’inclusion
    -Évaluer l'impact du bimekizumab sur l'amélioration fonctionnelle
    -Évaluer l'impact du bimekizumab sur les modifications radiographiques des mains et des pieds
    -Évaluer l'impact du bimekizumab sur les manifestations extra-articulaires de la maladie (dactylite, enthésite)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    For individuals consenting to the genomics, genetics, and proteomics substudy, blood samples will be drawn for exploratory genetic/epigenetic, genomic, proteomic, and metabolomics analysis and for candidate exploratory biomarker analyses.
    Pour les patients ayant consentis à la sous-étude de génomiques, génétiques, et protéomiques, des échantillons sanguins seront prélevés pour des explorations génétique/épigénétique, génomique, protéomique, et des analyses métabolomiques et des analyses de recherche de biomarqueurs exploratoires pour les candidats.
    E.3Principal inclusion criteria
    - Subject is male or female at least 18 years of age
    - Female subject must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
    - Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) ≥3 out of 68 and swollen joint count (SJC) ≥ 3 out of 66
    - Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
    - Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
    - Subject must be a suitable candidate for treatment with adalimumab and has no contraindications to receive adalimumab as per the local label as assessed by the Investigator
    - Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry
    -Le patient est un homme ou une femme âgé(e) d’au moins 18 ans
    -Les patientes doivent être ménopausées, stérilisées de manière permanente, ou, doivent être prêtes à utiliser une méthode de contraception très efficace
    -Diagnostic documenté de RPs de l’adulte et répond aux critères de classification du rhumatisme psoriasique (CASPAR) pendant au moins 6 mois avant la sélection avec un RPs actif et doit présenter un nombre d'articulations douloureuses (NAD) ≥ 3 sur 68 et un nombre d'articulations enflées (NAE) ≥ 3 sur 66
    -Le patient doit présenter un résultat négatif pour le facteur rhumatoïde et pour les anticorps anti-peptide citrulliné cyclique (CCP)
    -Le patient doit présenter au moins 1 lésion de psoriasis active et/ou des antécédents documentés de PSO
    -Le patient doit être considéré, selon l'investigateur, comme un bon candidat à un traitement par adalimumab conformément à l'étiquetage régional et ne présente pas de contre-indications à recevoir de l’adalimumab conformément à l'étiquette locale
    -Les patients prenant actuellement des AINS, des inhibiteurs de cyclooxygénase 2 (COX-2), des analgésiques, des corticostéroides, des methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) ET/OU aprémilast peuvent être autorisés si les critères requis avant l'entrée dans l'étude sont respectés.
    E.4Principal exclusion criteria
    - Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
    - Subjects with current or prior exposure to any biologics for the treatment of Psoriatic Arthritis (PsA) or Psoriasis (PSO)
    - Subject has an active infection or a history of recent serious infections
    - Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
    - Subject has a diagnosis of inflammatory conditions other than PSO or PsA. Subjects with a diagnosis of Crohn’s disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline
    - Subject had acute anterior uveitis within 6 weeks of Baseline
    - Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
    - Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO)
    - Presence of active suicidal ideation, or moderately severe major depression or severe major depression
    - Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
    -Femmes qui allaitent, enceintes ou souhaitant l'être au cours de l'étude
    -Patients actuellement exposés ou ayant été exposés à des agents biologiques pour le traitement du rhumatisme psoriasique (RPs) ou du psoriasis (PSO)
    -Infection active ou antécédents de récentes sérieuses infections
    -Infection tuberculeuse (TB) connue, risque élevé d'acquisition d'une infection TB ou présence en cours ou passée d'une infection à mycobactérie non tuberculeuse (NTMB, nontuberculous mycobacterium)
    -Le patient a reçu un diagnostic de maladies inflammatoires autres que le PSO ou le RP. Les patients ayant reçu un diagnostic de maladie de Crohn, de rectocolite hémorragique ou d’une autre maladie inflammatoire chronique de l’intestin (MICI) sont autorisés tant que leur maladie n'est pas active et symptomatique lors de la sélection ou de l'inclusion
    -Le patient a présenté une uvéite antérieure aiguë dans les 6 semaines précédant l'inclusion
    -Le patient présente une tumeur maligne active ou des antécédents de tumeur maligne dans les 5 ans précédant la visite d'inclusion SAUF en cas de carcinome cutané épidermoïde ou basocellulaire ou de cancer du col de l'utérus in situ traité et considéré comme guéri
    -Le patient présente une forme de PSO autre que le PSO en plaques chronique (p. ex., PSO pustuleux, érythrodermique et en gouttes ou PSO d'origine médicamenteuse)
    -Présence d'idées suicidaires actives ou d'une dépression majeure modérément sévère ou une dépression majeure sévère
    -Le patient a des antécédents d'abus chronique de drogues ou d'alcool dans les 6 mois précédant la sélection
    E.5 End points
    E.5.1Primary end point(s)
    American College of Rheumatology 50% improvement (ACR50) response at Week 16
    Réponse ACR50 à la semaine 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Week 16
    sélection, semaine 16
    E.5.2Secondary end point(s)
    1. Psoriasis Area Severity Index 90 (PASI90) response at Week 4 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline
    2. Psoriasis Area Severity Index 90 (PASI90) response at Week 16 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline
    3. Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16
    4. Change from Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) at Week 16
    5. Minimal Disease Activity (MDA) at Week 16
    6. Change from Baseline in Van der Heijde modified Total Sharp Score (vdHmTSS) at Week 16
    7. Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 16 in the subgroup of subjects with dactylitis at Baseline
    8. Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 16 in the subgroup of subjects with enthesitis at Baseline
    9. American College of Rheumatology 20% improvement (ACR20) response at Week 16
    10. American College of Rheumatology 70% improvement (ACR70) response at Week 16
    11. Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 4 in the subset of subjects with psoriatic skin lesions at Baseline
    12. Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 16 in the subset of subjects with psoriatic skin lesions at Baseline
    13. Change from Baseline in the Patient’s Assessment of Arthritis Pain (PtAAP) at Week 16
    14. Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 16 in the subgroup of subjects with enthesitis at Baseline
    15. Change from Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) at Week 16
    16. Incidence of treatment-emergent adverse events (TEAEs) during the study
    17. Incidence of serious adverse events (SAEs) during the study
    18. Adverse events (AEs) leading to withdrawal from investigational medicinal product (IMP) during the study
    1.Réponse PASI90 (indice d'étendue et de sévérité du psoriasis) à la semaine 4 dans le sous-groupe de patients atteints de PSO affectant au moins 3 % de la surface corporelle à l’inclusion
    2. Réponse PASI90 (indice d'étendue et de sévérité du psoriasis) à la semaine 16 dans le sous-groupe de patients atteints de PSO affectant au moins 3 % de la surface corporelle à l’inclusion
    3.Variation entre l’inclusion et la semaine 16 du score HAQ-DI
    4.Variation entre l’inclusion et la semaine 16 du score PCS (volet sur l'état physique) du SF-36
    5.Réponse MDA (activité minimale de la maladie) à la semaine 16
    6.Variation entre l’inclusion et la semaine 16 du score vdHmTSS (score total de Sharp modifié par Van der Heijde)
    7.État sans dactylite basé sur le LDI (indice de Leeds pour la dactylite) à la semaine 16 dans le sous-groupe de patients atteints de dactylite à l’inclusion
    8.État sans enthésite basé sur le LEI (indice de Leeds pour l’enthésite) à la semaine 16 dans le sous-groupe de patients atteints d’enthésite à l’inclusion
    9.Réponse ACR20 à la semaine 16
    10.Réponse ACR70 à la semaine 16
    11.Proportion de patients ayant un score IGA (évaluation globale réalisée par l’investigateur) de 0 (clair) ou 1 (presque clair) ET présentant au moins une réduction de 2 grades entre l’inclusion et la semaine 4 dans le sous-groupe de patients présentant des lésions cutanées de psoriasis à l’inclusion
    12.Proportion de patients ayant un score IGA (évaluation globale réalisée par l’investigateur) de 0 (clair) ou 1 (presque clair) ET présentant au moins une réduction de 2 grades entre l’inclusion et la semaine 16 dans le sous-groupe de patients présentant des lésions cutanées de psoriasis à l’inclusion
    13.Variation entre l’inclusion et la semaine 16 du score PtAAP (évaluation des douleurs arthritiques réalisée par le patient)
    14.État sans enthésite basé sur l’indice SPARCC (Consortium de recherche sur la spondylarthrite du Canada) à la semaine 16 dans le sous-groupe de patients atteints d’enthésite à l’inclusion
    15.Variation entre l’inclusion et la semaine 16 du score PsAID-12 (impact du rhumatisme psoriasique sur la santé)
    16. Incidence des évènements indésirables apparus pendant le traitement (EIAT)
    17.Incidence des EIG
    18.Évènements indésirables (EI) entraînant l’arrêt du ME
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.; 11. Baseline, Week 4
    5. Week 16
    2.-4.; 6.-10.; 12.-15. Baseline, Week 16
    16.-18. From Baseline until Safety Follow-Up
    (up to Week 72)
    1.-11. inclusion, semaine 4
    5. semaine 16
    2.-4.; 6.-10.; 12.-15. inclusion, semaine 16
    16.-18. de l'inclusion jusqu'au suivi de l'innocuité (jusqu'à semaine 72)
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, Tolerability
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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
    Australia
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Japan
    Poland
    Russian Federation
    Spain
    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
    Last subject last visit (LSLV)
    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 months11
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days13
    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: 754
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 86
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 445
    F.4.2.2In the whole clinical trial 840
    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)
    Eligible subjects will be allowed to enroll in an extension study.
    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 Decision2019-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-11
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