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    Summary
    EudraCT Number:2021-006126-52
    Sponsor's Protocol Code Number:CUV803
    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:2022-10-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2021-006126-52
    A.3Full title of the trial
    A Phase IIa, Open Label, Proof of Concept Study to Evaluate the Safety of Aqueous Afamelanotide Solution in Patients with acute Arterial Ischaemic Stroke (AIS) who are ineligible for Intravenous Thrombolysis (IVT) or Endovascular Thrombectomy (EVT)
    Estudio de fase IIa, no ciego, prueba de concepto para evaluar la seguridad de la solución acuosa de afamelanotida en pacientes con infarto agudo de origen arterial (IAA) que no son candidatos a trombólisis intravenosa (IVT) o trombectomía endovascular (EVT).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IIa Aqueous Afamelanotide Solution Stroke Study
    Estudio de accidente cerebrovascular en solución acuosa de afamelanotida de fase IIa
    A.4.1Sponsor's protocol code numberCUV803
    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 SponsorCLINUVEL EUROPE LIMITED
    B.1.3.4CountryIreland
    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 supportCLINUVEL EUROPE LIMITED
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCLINUVEL EUROPE LIMITED
    B.5.2Functional name of contact pointHead of Clinical Operations
    B.5.3 Address:
    B.5.3.1Street Address10 Earlsfort Terrace
    B.5.3.2Town/ cityDublin
    B.5.3.3Post codeD02 T380
    B.5.3.4CountryIreland
    B.5.4Telephone number+35315134932
    B.5.6E-mailmail@clinuvel.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 nameAfamelanotide aqueous solution
    D.3.4Pharmaceutical form Solution for injection in vial
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSolution for injection (Noncurrent)
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAfamelanotide
    D.3.9.1CAS number 75921-69-6
    D.3.9.3Other descriptive namePRENUMBRA®
    D.3.9.4EV Substance CodeSUB33758
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Arterial Ischaemic Stroke (AIS)
    infarto agudo de origen arterial (IAA)
    E.1.1.1Medical condition in easily understood language
    Arterial Ischaemic Stroke (AIS)
    infarto agudo de origen arterial (IAA)
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level PT
    E.1.2Classification code 10061256
    E.1.2Term Ischaemic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    (i) Evaluate the safety of afamelanotide in acute Arterial Ischaemic Stroke (AIS).
    Evaluar la seguridad de la afamelanotida en el accidente cerebrovascular isquémico arterial agudo (IAA).
    E.2.2Secondary objectives of the trial
    (ii) Evaluate the impact of afamelanotide on neurological functions in patients with acute Arterial Ischaemic Stroke (AIS) using the National Institutes of Health Stroke Scale (NIHSS).
    (iii) Identify changes in reperfusion of the ischaemic penumbra in AIS patients, specifically the ischaemic core and/ or the penumbral ischaemic zone (salvageable tissue), following treatment with afamelanotide.
    (iv) Assess cognitive functions and activities of daily living in AIS patients following treatment with afamelanotide.
    (v) Assess the impact of afamelanotide on systemic oxidative stress.
    (ii) Evaluar el impacto de la afamelanotida en las funciones neurológicas en pacientes con accidente cerebrovascular isquémico arterial agudo (IAA) utilizando la Escala de Accidentes Cerebrovasculares de los Institutos Nacionales de Salud (NIHSS).
    (iii) Identificar cambios en la reperfusión de la penumbra isquémica en pacientes con IAA, específicamente el núcleo isquémico y/o la zona de penumbra (tejido rescatable), después del tratamiento con afamelanotida.
    (iv) Evaluar las funciones cognitivas y actividades de la vida diaria en pacientes con IAA después del tratamiento con afamelanotida.
    (v) Evaluar el impacto de la afamelanotida sobre el estrés oxidativo sistémico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female subjects with a diagnosis of first AIS
    • Six patients mild to moderate stroke severity (defined as NIHSS score of 1-15) and six patients moderate to severe stroke severity (defined as NIHSS score of 16-42)
    • At least three patients with an NIHSS score of 1-15 and at least three patients with NIHSS score greater than 15 will be recruited with perfusion abnormalities observed on Computed Tomography Perfusion (CTP) and the rest of the patients with no perfusion abnormalities but with clinically suspected AIS
    • Pre-stroke mRS <4
    • Aged 18- 85 years
    • Written informed consent obtained from patient and/or medical treatment decision maker prior to study-start (upon admission)
    Para ser elegible para participar en el estudio, los pacientes deben cumplir con los siguientes criterios de inclusión:
    • Sujetos masculinos o femeninos con diagnóstico de primer SIA
    • Seis pacientes evalúan de ma moderada la gravedad del accidente cerebrovascular (definida como puntuación NIHSS de 1-15) y seis pacientes con gravedad moderada a grave (definida como puntuación NIHSS de 1 6-42)
    • Al menos tres pacientes con una puntuación NIHSS de 1-15 y al menos tres pacientes con puntuación NIHSS superiora 1 5 serán reclutados con anomalías de perfusión observadas en la perfusión por tomografía computarizada (CTP) y el resto de los pacientes sin anomalías de perfusión pero con sospecha clínica de AIS
    • mRS pre-carrera <4
    • De 18 a 85 años
    • Consentimiento informado por escrito obtenido del paciente y/o del responsable de la toma de decisiones del tratamiento médico antes del inicio del estudio (al momento de la admisión).
    E.4Principal exclusion criteria
    • Administration of intravenous thrombolytic therapy in distal occlusion as etiology of AIS
    • Intervention by endovascular thrombectomy (EVT)
    • Known allergy or anaphylaxis to adrenocorticotropic hormone (ACTH) or melanocortins or any of the excipients listed in the Investigator’s Brochure
    • Any evidence of hepatic (defined as three times standard range) or renal impairment (defined as eGFR <50 mL/min/1.73 m²)
    • Any other medical condition which may interfere with the study protocol
    • Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to baseline) or lactating
    • Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device) or a lifestyle excluding pregnancy
    • Unable to undergo MRI brain evaluation
    • Not suitable for trial participation according to judgment of the Principal Investigator (PI)
    • Patients starting afamelanotide 24 hours or more from stroke.
    Para ser elegible para participar en el estudio, los pacientes no deben cumplir con ninguno de los siguientes criterios de exclusión:
    • Administración de terapia trombolítica intravenosa en la oclusión distal como etiología del SIA
    • Intervención mediante trombectomía endovascular (EVT)
    • Alergia o anafilaxia conocida a unahormona drenocorticotrópica (ACTH) o melanocortins o cualquiera de los excipientes enumerados en el folleto del investigador
    • Cualquier evidencia de insuficiencia hepática (definida como tres veces el rango estándar) o renal (definida como eTFG <50 ml/min/1,73 m²)
    • Cualquier otra condición médica que pueda interferir con el protocolo del estudio
    • Mujer embarazada (confirmada por prueba de embarazo serum positiva β-HCG antes del inicio del estudio) o lactante
    • Mujeres con potencial fértil (premenopáusicas, no quirúrgicamente estériles) que no utilizan medidas anticonceptivas adecuadas (es decir, anticonceptivos orales, diafragma más espermicida, dispositivo intrauterino) o un estilo de vida que excluye el embarazo
    • Incapaz de someterse a una resonancia magnética cerebral evaloración
    • No apto para la participación en juicios según sentencia del Investigador Principal (IP)
    • Pacientes que comienzan afamelanotida 24 horas o más por accidente cerebrovascular.
    E.5 End points
    E.5.1Primary end point(s)
    i) Safety of afamelanotide by monitoring and recording treatment-emergent AEs (TEAEs) (on all days of administration and up to day 42(±7)).
    (1) Seguridad de la afamelanotida mediante la monitorización y el registro de los EA emergentes del tratamiento (TEAE) (en todos los días de administración y hasta el día 42(±7)).
    E.5.1.1Timepoint(s) of evaluation of this end point
    On all days of administration and up to day 42(±7)).
    En todos los días de administración y hasta el día 42(±7).
    E.5.2Secondary end point(s)
    (ii) NIHSS scores on Days 1, 3(-1), 5 (can be done earlier if the patient is discharged earlier), before discharge (if applicable) and 42(±7) compared to baseline.
    (iii) Reperfusion volume of the ischaemic core and the penumbral ischaemic zone (salvageable tissue) comparing baseline and Day 3(±1), Day 42(±7) as appropriate.
    (iv) mRS scores on Days 3(-1), 5 (can be done earlier if the patient is discharged earlier) and 42(±7) compared to baseline and pre-stroke; Activities of Daily Living (ADL) on Days 3(-1), 5 (can be done earlier if the patient is discharged earlier) and 42(±7) compared to baseline and pre-stroke
    (v) MMSE scores on Days 3(-1), 5 (can be done earlier if the patient is discharged earlier) and 42(±7) compared to baseline and
    (vi) Urine 8-oxo-dG level as indicator of systemic oxidative stress on Days 1, 5 (can be done earlier if the patient is discharged earlier), before discharge (if applicable), and 42(±7) compared to baseline.
    (ii) Las puntuaciones de NIHSS en los días 1, 3 (-1), 5 (se puede hacer antes si el paciente es dado de alta antes), antes del alta (si corresponde) y 42 (±7) en comparación con el valor inicial.
    (iii) Volumen de reperfusión del núcleo isquémico y la zona de penumbra isquémica(tejido rescatable) comparando el valor basal y el día 3(±1), día 42(±7) según corresponda.
    (iv) Puntuaciones de mRS en los días 3 (-1), 5 (se puede hacer antes si el paciente es dado de alta antes) y 42 (±7) en comparación con el valor basal y previo al accidente cerebrovascular; Actividades de la vida diaria (AVD) en los días 3 (-1), 5 (se puede hacer antes si el paciente es dado de alta antes) y 42 (±7) en comparación con el valor inicial y previo al accidente cerebrovascular
    (v) Puntuaciones de MMSE en los días 3 (-1), 5 (se puede hacer antes si el paciente es dado de alta antes) y 42 (±7) en comparación con el valor basal y
    (vi) Nivel de 8-oxo-dG en orina como indicador de estrés oxidativo sistémico en los días 1, 5 (se puede hacer antes si el paciente es dado de alta antes), antes del alta (si corresponde) y 42 (±7) en comparación con el valor basal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    (ii) Days 1, 3(-1), 5 (can be done earlier if the patient is discharged earlier), before discharge (if applicable) and 42(±7) compared to baseline.
    (iii) Comparing baseline and Day 3(±1), Day 42(±7) as appropriate.
    (iv) mRS scores on Days 3(-1), 5 (can be done earlier if the patient is discharged earlier) and 42(±7) compared to baseline and pre-stroke; Activities of Daily Living (ADL) on Days 3(-1), 5 (can be done earlier if the patient is discharged earlier) and 42(±7) compared to baseline and pre-stroke
    (v) MMSE scores on Days 3(-1), 5 (can be done earlier if the patient is discharged earlier) and 42(±7) compared to baseline and
    (vi) 8-oxo-dG on Days 1, 5 (can be done earlier if the patient is discharged earlier), before discharge (if applicable), and 42(±7) compared to baseline.
    (ii) Días 1,3(-1),5*, antes del alta (si corresponde) y 42(±7) en comparación con el valor inicial
    (iii) Comparando el valor basal y el día 3(±1), día 42(±7) según corresponda
    (iv) Puntuaciones de mRS en los días 3(-1),5* y 42(±7) en comparación con el valor basal y previo al accidente cerebrovascular; Actividades de la vida diaria (AVD) en los días 3(-1), 5* y 42(±7) en comparación con el valor inicial y previo al accidente cerebrovascular
    (v) Puntuaciones de MMSE en los días 3(-1),5* y 42(±7) en comparación con el valor basal
    (vi) Nivel de 8-oxo-dG en orina como indicador de estrés oxidativo sistémico en los días 1,5*, antes del alta (si corresponde) y 42(±7) en comparación con el valor basal


    *se puede hacer antes si el paciente es dado de alta antes
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    If the patient is unable to provide consent, a medical treatment decision maker will be informed about the trial. The subject or medical treatment decision maker must voluntarily sign an informed consent statement.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    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)
    There are no plans yet
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-13
    P. End of Trial
    P.End of Trial StatusOngoing
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