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    Summary
    EudraCT Number:2020-004047-86
    Sponsor's Protocol Code Number:AIS-A03
    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:2021-06-23
    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 number2020-004047-86
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALPN-101 IN SYSTEMIC LUPUS ERYTHEMATOSUS
    Estudio aleatorizado, en doble ciego y controlado con placebo de ALPN-101 en el lupus eritematoso sistémico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of ALPN-101 in Active Lupus
    Estudio de ALPN-101 en el lupus activo
    A.4.1Sponsor's protocol code numberAIS-A03
    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 SponsorAlpine Immune Sciences, Inc.
    B.1.3.4CountryUnited States
    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 supportAlpine Immune Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationParexel International
    B.5.2Functional name of contact pointHansi Kumari
    B.5.3 Address:
    B.5.3.1Street Address70 Sir John Rogerson's Quay
    B.5.3.2Town/ cityDublin
    B.5.3.3Post code2
    B.5.3.4CountryIreland
    B.5.4Telephone number+1954 232 9569
    B.5.6E-mailHansi.Kumari@parexel.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.3.2Product code ALPN-101
    D.3.4Pharmaceutical form 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 INNAcazicolcept
    D.3.9.1CAS number 2270247-50-0
    D.3.9.2Current sponsor codeALPN-101
    D.3.9.3Other descriptive nameALPN-101
    D.3.9.4EV Substance CodeSUB221298
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic lupus erythematosus (SLE)
    Lupus eritematoso sistémico
    E.1.1.1Medical condition in easily understood language
    Systemic Lupus
    lupus sistémico
    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 10042946
    E.1.2Term Systemic lupus erythematosus rash
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    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 10042948
    E.1.2Term Systemic lupus erythematosus syndrome aggravated
    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 10042947
    E.1.2Term Systemic lupus erythematosus synd
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10029142
    E.1.2Term Nephritis systemic lupus erythematosus
    E.1.2System Organ Class 100000004857
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10067657
    E.1.2Term Systemic lupus erythematosus disease activity index increased
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10067658
    E.1.2Term Systemic lupus erythematosus disease activity index decreased
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10067659
    E.1.2Term Systemic lupus erythematosus disease activity index abnormal
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10080670
    E.1.2Term Systemic lupus erythematosus reactivation
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10073694
    E.1.2Term Lupus pleurisy
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10040968
    E.1.2Term SLE arthritis
    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
    To evaluate the safety and tolerability of ALPN-101 compared to placebo in subjects with moderate to severe active SLE
    Evaluar la seguridad y tolerabilidad de ALPN-101 en comparación con placebo en sujetos con SLE activo de moderado a grave
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of ALPN-101 in subjects with active SLE
    • To assess the pharmacokinetics (PK) of ALPN-101 in active SLE
    • To assess the incidence of anti-drug antibodies (ADA) against ALPN-101
    • Evaluar la eficacia de ALPN-101 en sujetos con SLE activo
    • Evaluar la farmacocinética (PK) de ALPN-101 en el SLE activo
    • Evaluar la incidencia de anticuerpos antimedicamento (ADA) contra ALPN-101
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Written informed consent
    •Age 18 to 65
    •Diagnosis of lupus for ≥ 6 months prior to Screening
    •Positive ANA and/or elevated anti-dsDNA and/or elevated anti-Smith antibody test at Screening
    •Active lupus at Screening and Baseline, as defined per-protocol and confirmed by the study's medical monitor
    •Standard lupus medications must be stable prior to Screening
    •Women must have a PAP smear and known HPV status within 12 months of Day 1
    •All participants must use highly effective birth control if they/their partner are capable of becoming pregnant
    • Consentimiento informado por escrito
    • De 18 a 65 años
    • Diagnóstico de SLE en los ≥ 6 meses anteriores a la selección
    • Prueba de anticuerpos antinucleares (antinuclear antibody, ANA) positiva y/o elevación de anticuerpos anti-DNA y/o elevación de anticuerpos anti-Smith en la selección
    • SLE activo en la selección, confirmado por el el monitor médico del estudio y en el momento basal
    • Tratamiento habitual estable y apropiado para el SLE previo a la selección
    • Mujeres con el útero intacto: prueba de Papanicolaou con estado del virus del papilomavirus humano (human papillomavirus, HPV) <=12 meses antes del momento basal (día 1)
    • Todos los participantes deberán utilizar métodos anticonceptivos altamente efectivos si ellas/sus parejas pueden quedarse embarazadas
    E.4Principal exclusion criteria
    •Life-threatening or organ system-threatening lupus activity that is anticipated to require increased treatment during the study
    •Proteinuria consistent with nephrotic syndrome
    •Active lupus-related neuropsychiatric disease
    •Drug-induced lupus
    •Any serious health condition that would place the subject at undue risk from the study or would confound interpretation of safety or efficacy outcomes
    •Recent or serious ongoing infection; risk or history of serious infection
    •Receipt of live vaccination within 8 weeks of Day 1, or expected to require live vaccination during the study
    •Unacceptable Screening laboratory results
    •History of new, ongoing, or recurrent malignancy <= 5 years prior to Day 1, with some exceptions per-protocol
    •Pregnant or breastfeeding at the time of screening, or plans to become pregnant <= 3 months following the last dose of study drug
    •Prior diagnosis of, or fulfills diagnostic criteria for, another rheumatic disease that overlaps with lupus or another autoimmune or inflammatory disease that may confound clinical assessments or increase subject risk in the study
    •Diagnosis of, or fulfills diagnostic criteria for, fibromyalgia
    •Functional class IV lupus
    •Does not meet protocol washout periods for concomitant medications
    •Serious lupus disease activity, which warrants immediate immunosuppressive therapy not appropriate for the study or which makes the possibility of receiving placebo or investigational agent an inappropriate risk
    •Ongoing participation in another therapeutic clinical trial
    •Known hypersensitivity to ALPN-101, components thereof, or excipients contained in the drug formulation
    • Actividad del SLE que ponga en peligro la vida o afecte gravemente a órganos y sistemas y que sea lo suficientemente activo como para que se espere que requiera un aumento del tratamiento durante el estudio
    • Proteinuria compatible con síndrome nefrótico3.
    • Enfermedad neuropsiquiátrica activa relacionada con el lupus
    • Lupus inducido por medicamentos
    • Cualquier enfermedad o trastorno grave que pudiera poner al sujeto en un riesgo excesivo por el estudio o pudiera confundir la interpretación de los resultados de seguridad o eficacia
    • Infección grave reciente o en curso; riesgo o antecedentes de infección grave
    • Administración de vacunas con gérmenes vivos ≤8 semanas antes del momento basal (es decir, el día 1 antes de la aleatorización) o previsión de que requieran vacunas con gérmenes vivos durante el estudio
    • Resultados de laboratorio de la selección no aceptables
    • Antecedentes de neoplasias malignas nuevas, en curso o recurrentes de <=5 años antes de la administración de la primera dosis del medicamento del estudio, con ciertas excepciones señaladas en el protocolo
    • Embarazo o lactancia en la selección, o planificación de embarazo <=3 meses después de la última dosis del medicamento del estudio
    • Cumplimiento de los criterios diagnósticos de otra enfermedad reumática que se solape con el SLE y pueda confundir las evaluaciones clínicas en el estudio
    • Diagnóstico previo o cumplimiento de los criterios diagnósticos de fibromialgia
    • SLE de clase funcional IV
    • No cumplir los periodos de lavado de los medicamentos concomitantes señalados por el protocolo
    • Actividad grave del SLE que, en opinión del investigador, justifique un tratamiento inmunosupresor inmediato no apropiado para el estudio o que haga que la posibilidad de recibir placebo o un medicamento en investigación suponga un riesgo inadecuado
    • Participación en curso en otro ensayo clínico terapéutico
    • Hipersensibilidad conocida al ALPN-101, a sus componentes o a los excipientes contenidos en la formulación del medicamento
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability will be assessed by evaluating the type, frequency, severity, and seriousness of adverse events, including clinically significant changes in symptoms, physical exam findings, vital signs, laboratory tests (hematology, serum chemistries and coagulation, urinalysis), and electrocardiograms.
    La seguridad y la tolerabilidad se evaluarán a partir del tipo, la frecuencia, la severidad y la gravedad de los acontecimientos adversos, incluidos los cambios clínicamente significativos en los síntomas, los resultados de la exploración física, las constantes vitales, las pruebas de laboratorio (hematología, bioquímica sérica y coagulación, análisis de orina) y los electrocardiogramas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    According to protocol
    De acuerdo con el protocolo
    E.5.2Secondary end point(s)
    Efficacy Endpoints:
    Efficacy endpoints will be assessed by evaluating disease activity relative to baseline and across treatment groups using the tools and assessments listed below, and derivatives calculated from them (e.g. SLE Responder Index [SRI] -4, -5, -6 response; time to and proportion with flare of SLE; others).
    -Global disease Activity Assessment Tools:
    • BILAG 2004
    • SLEDAI-2K; SLEDAI-2K 30
    • Physician’s Global Assessment of SLE Disease Activity (PhGA)
    -Organ-Specific Disease Activity Assessment Tools:
    • Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), with photography when appropriate
    • Swollen joints based on assessment of 28 joints (SJC-28)
    • Tender joints based on assessment of 28 joints (TJC-28)
    • Estimated glomerular filtration rate (eGFR)
    • Proteinuria assessed as urine protein to creatinine ratio (UPCR),
    • Urinary sediment analysis for hematuria, pyuria, and red cell casts
    -Patient Reported Outcomes and Quality of Life (QoL) Assessment tools:
    • Patient’s Global Assessment of Disease Activity (PtGA)
    • Short Form Health Survey-36 (SF-36)
    • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (13-Item)
    -Clinical Biomarkers of SLE Activity:
    • High-sensitivity C-reactive protein (hsCRP)
    • Complement levels: C3, C4, CH50
    • Anti-dsDNA antibodies
    -Corticosteroids:
    • Dose of oral and parenteral corticosteroids

    Pharmacokinetic Endpoints:
    Serum concentrations of ALPN-101 will be measured. Pharmacokinetic endpoints include estimates of maximum observed concentration (Cmax), area under the concentration-time curve (AUC), and trough concentration at the end of dosing intervals (Ctrough).

    Immunogenicity Endpoints:
    The presence and titer of ADA against ALPN-101 will be assessed at Baseline (prior to study drug administration on Day 1) and at intervals throughout the study. Samples confirmed positive for ADA may be explored for neutralizing (NAb) capacity. The relationship between ADA and PK will be analyzed; relationship between ADA and clinical outcomes may be explored.

    Pharmacodynamic Endpoints:
    Blood and urine will be collected at intervals; target saturation by ALPN-101 on circulating lymphocytes will be assessed; plasma, sera and peripheral blood mononuclear cells (PBMCs) will be prepared and may be assessed for biomarkers.
    Criterios de valoración de la eficacia:
    Los criterios de valoración de la eficacia se basarán en la actividad de la enfermedad en relación con el valor basal y en todos los grupos de tratamiento, utilizando los instrumentos y valoraciones que se indican a continuación, y las derivadas calculadas a partir de ellos (por ejemplo, respuesta 4, 5 o 6 en el índice de respondedores del SLE [SLE Responder Index, SRI]; el tiempo transcurrido hasta la aparición de un brote de SLE y el porcentaje de estos; otros).
    Instrumentos de valoración global de la actividad de la enfermedad:
    • Índice BILAG 2004 (British Isles Lupus Assessment Group)
    • Índices de actividad del lupus eritematoso sistémico (SLEDAI-2K y SLEDAI-2K 30)
    • Evaluación global de la actividad del SLE por parte del médico (Physician’s Global Assessment, PhGA)
    Instrumentos de valoración de la actividad de la enfermedad específicos de órgano:
    • CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index), con fotografía cuando corresponda
    • Recuento de articulaciones tumefactas, basándose en la evaluación de 28 articulaciones (swollen joint count based on assessment of 28 joints, SJC-28)
    • Recuento de articulaciones dolorosas a la palpación, basándose en la evaluación de 28 articulaciones (tender joint count based on assessment of 28 joints, TJC-28)
    • Tasa de filtración glomerular estimada (estimated glomerular filtration rate, eGFR)
    • Proteinuria como relación proteína/creatinina en orina (urine protein to creatinine ratio, UPCR)
    • Análisis del sedimento urinario para detectar hematuria, piuria y cilindros de hematíes
    Resultados comunicados por el paciente e instrumentos de evaluación de la calidad de vida (quality of life, QoL):
    • Evaluación global de la actividad de la enfermedad por parte del paciente (Patient’s Global Assessment, PtGA)
    • Encuesta breve de salud-36 (SF-36, short form-36)
    • Evaluación funcional del tratamiento en enfermedades crónicas – fatiga (13 ítems) (FACITī€­F, Functional Assessment of Chronic Illness Therapy-Fatigue, 13 items)
    Biomarcadores clínicos de la actividad del SLE:
    • Prueba de proteína C reactiva de alta sensibilidad (high-sensitivity C-reactive protein, hsCRP)
    • Nivel de complementos: C3, C4, CH50
    • Anticuerpos anti-dsDNA
    Corticoides:
    • Dosis de corticoides orales y parenterales

    Criterios de valoración de la farmacodinámica:
    Se medirán las concentraciones séricas de ALPN-101. Los criterios de valoración farmacocinética incluyen estimaciones de la concentración máxima observada (Cmax), el área bajo la curva de concentración-tiempo (area under the curve, AUC) y la concentración valle o concentración al final de los intervalos de administración (trough concentration, Ctrough).

    Criterios de valoración de la inmunogenicidad
    La presencia y el título de ADA contra ALPN-101 se evaluarán en el momento basal (antes de la administración del medicamento del estudio el día 1) y a intervalos en el transcurso del estudio. Las muestras que den positivo en ADA se explorarán para determinar la capacidad neutralizante (neutralizing antibodies, Nab). Se analizará la relación entre los ADA y la PK; se podrá explorar la relación entre los ADA y los resultados clínicos.

    Criterios de valoración de la farmacodinámica
    Se recogerán muestras de sangre y orina a intervalos; se evaluará el objetivo de saturación de ALPN-101 en los linfocitos circulantes; se preparará plasma, suero y células mononucleares de sangre periférica (peripheral blood mononuclear cells, PBMC) para evaluar la presencia de biomarcadores.
    E.5.2.1Timepoint(s) of evaluation of this end point
    According to protocol
    De acuerdo con el protocolo
    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
    Immunogenicity
    Inmunogenicidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    France
    Germany
    Korea, Republic of
    Poland
    Russian Federation
    Spain
    United States
    E.8.7Trial has a data monitoring committee No
    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
    Última Visita del Último Paciente (Last Patient Last Visit)
    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 days16
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 130
    F.1.3Elderly (>=65 years) No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 41
    F.4.2.2In the whole clinical trial 130
    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)
    None
    Ninguno
    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 Decision2021-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-25
    P. End of Trial
    P.End of Trial StatusOngoing
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