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    Summary
    EudraCT Number:2021-001419-10
    Sponsor's Protocol Code Number:CUV152
    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:2021-11-17
    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 number2021-001419-10
    A.3Full title of the trial
    A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide in Patients with Xeroderma Pigmentosum C and V (XPC and XPV)
    Estudio preliminar de fase IIa, sin enmascaramiento, para evaluar la seguridad y la eficacia de los implantes subcutáneos de afamelanotida en pacientes con xerodermia pigmentosa C y V (XPC y XPV)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the safety and the efficacy of the photoprotective drug, afamelanotide in patients with Xeroderma Pigmentosum C and V
    Estudio para evaluar la seguridad y eficacia del fármaco fotoprotector afamelanotida en pacientes con Xeroderma Pigmentosum C y V
    A.3.2Name or abbreviated title of the trial where available
    Phase IIa XPC and XPV Study
    Estudio de fase IIa en XPC y XPV
    A.4.1Sponsor's protocol code numberCUV152
    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 organisationCLINVEL 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.5.6E-mailmail@clinuvel.ccom
    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 Yes
    D.2.1.1.1Trade name SCENESSE
    D.2.1.1.2Name of the Marketing Authorisation holderCLINUVEL EUROPE LIMITED
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/08/541
    D.3 Description of the IMP
    D.3.1Product nameAfamelanotide (16 mg implant)
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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
    Patients with Xeroderma Pigmentosum C and V
    Pacientes con Xerodermia Pigmentosa C y V
    E.1.1.1Medical condition in easily understood language
    Patients with Xeroderma Pigmentosum C and V
    Pacientes con Xerodermia Pigmentosa C y V
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the impact of afamelanotide on minimal erythema dose (MED) in patients with XPC
    Evaluate the impact of afamelanotide on MED in patients with XPV.
    Evaluar el efecto de la afamelanotida en la dosis eritematógena mínima (DEM) en pacientes con XPC
    Evaluar el efecto de la afamelanotida en la DEM en pacientes con XPV.
    E.2.2Secondary objectives of the trial
    Evaluate the impact of afamelanotide on UV-induced DNA damage and repair capacity in patients with XPC.
    Evaluate the impact of afamelanotide on UV-induced DNA damage and repair capacity in patients with XPV.
    Evaluate the impact of afamelanotide on melanin density in patients with XPC.
    Evaluate the impact of afamelanotide on melanin density in patients with XPV.
    Evaluate the safety and tolerability of afamelanotide in patients with XP.
    Evaluate the impact of afamelanotide on the skin disease severity of patients with XPC.
    Evaluate the impact of afamelanotide on the skin disease severity of patients with XPV.
    • Evaluate the impact of afamelanotide on the quality of life of patients with XPC.
    • Evaluate the impact of afamelanotide on the quality of life of patients with XPV
    Evaluar el efecto de la afamelanotida en el daño inducido en el ADN por la radiación UV y en la capacidad de reparación en pacientes con XPC.
    Evaluar el efecto de la afamelanotida en el daño inducido en el ADN por la radiación UV y en la capacidad de reparación en pacientes con XPV.
    Evaluar el efecto de la afamelanotida en la densidad de melanina en pacientes con XPC.
    Evaluar el efecto de la afamelanotida en la densidad de melanina en pacientes con XPV.
    Evaluar la seguridad y la tolerabilidad de la afamelanotida en pacientes con XP.
    Evaluar el efecto de la afamelanotida en la gravedad de la enfermedad cutánea en pacientes con XPC.
    Evaluar el efecto de la afamelanotida en la gravedad de la enfermedad cutánea en pacientes con XPV.
    Evaluar el efecto de la afamelanotida en la calidad de vida de los pacientes con XPC.
    Evaluar el efecto de la afamelanotida en la calidad de vida de los pacientes con XPV
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male or female patient with a molecular-genetically confirmed diagnosis of XPC or XPV.
    -Aged 18-75 years.
    -Providing written Informed Consent prior to the performance of any study-specific procedure.
    -Willing and able to comply with the conditions specified in the protocol and study procedures, in the opinion of the Investigator.
    -Hombre o mujer con un diagnóstico de XPC o XPV confirmado por genética molecular.
    -Edad entre 18 y 75 años.
    -Entrega del consentimiento informado por escrito antes de la realización de cualquier procedimiento del estudio.
    -Voluntad y capacidad de cumplir las condiciones especificadas en el protocolo y los procedimientos del estudio, en opinión del investigador.
    E.4Principal exclusion criteria
    -Known allergy to afamelanotide or the polymer contained in the implant;
    -Presence of severe hepatic disease or hepatic impairment;
    -Renal impairment;
    -Any other medical condition which may interfere with the study protocol;
    -Existing melanoma;
    -Female who is pregnant (confirmed by positive urine β-HCG pregnancy test) 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 life-style excluding pregnancy, for up to three months after the last implant administration;
    -Sexually active man with a partner of child-bearing potential (pre-menopausal, not surgically sterile) who is not using adequate contraceptive measures, as described above;
    -Use of any other prior and concomitant therapy which may interfere with the objective of the study, within 30 days prior to the Screening visit;
    -Participation in a clinical trial for an investigational agent within 30 days prior to the Screening visit;
    -Not suitable for trial participation in the opinion of the Investigator.
    -Alergia conocida a la afamelanotida o al polímero que contiene el implante;
    -Enfermedad hepática grave o insuficiencia hepática;
    -Insuficiencia renal;
    -Cualquier otra enfermedad que pueda interferir con el protocolo del estudio;
    -Melanoma;
    -Mujer embarazada (confirmación mediante prueba positiva de embarazo de β-HCG en orina) o que esté dando el pecho;
    -Mujeres en edad fértil (premenopáusicas, sin esterilización quirúrgica) que no utilicen métodos anticonceptivos adecuados (es decir, anticonceptivos orales, diafragma más espermicida, dispositivo intrauterino) o que contemplen quedarse embarazadas en los tres meses posteriores a la última administración del implante;
    -Hombres activos sexualmente, con una pareja en edad fértil (premenopáusica, sin esterilización quirúrgica) que no utilice los métodos anticonceptivos descritos anteriormente;
    -Uso de cualquier otro tratamiento previo o concomitante que pueda interferir con el objetivo del estudio en los 30 días previos a la visita de cribado;
    -Participación en un ensayo clínico de un fármaco en investigación en los 30 días previos a la visita de cribado;
    -Persona no apta para la participación en el ensayo en opinión del investigador.
    E.5 End points
    E.5.1Primary end point(s)
    The change in MED
    El cambio en la DEM
    E.5.1.1Timepoint(s) of evaluation of this end point
    Analysis will compare the individual fold increase in MED from Day 0 to the post-treatment assessment at Day 76.
    El análisis se comparará el múltiplo de incremento individual en la DEM desde el día 0 hasta la evaluación postratamiento el día 76.
    E.5.2Secondary end point(s)
    •The changes in UV-induced DNA damage and repair capacity from baseline Day 0 to Day 76 or Premature Termination Visit (if applicable), as measured through analysis of UV photoproducts and DNA repair mechanisms on irradiated skin in comparison with non-irradiated skin.
    •The change in skin disease severity from Screening/Day -1/Day 0 to Day 70, Day 75 or 76 or Premature Termination Visit (if applicable) and Day 238(±14) as measured by:
    5-point IGA scale;
    11-point Likert-type scale.
    •The change in (skin) disease severity from Screening/Day -1/Day 0 to Day 75 or 76 or Premature Termination Visit (if applicable) and Day 238(±14) as measured by the European XP severity score.
    •The change in melanin density from baseline Day -1 or 0 to Days 28, 56, 75 or 76 or Premature Termination Visit (if applicable) and Day 238(±14) as measured by spectrophotometry.
    •The change in Quality of Life from Screening/Day -1/Day 0 to Days 70, 75 or 76 or Premature Termination Visit (if applicable) and Day 238(±14), as measured by the two instruments:
    WPAI:GH;
    XP-derived QOLEB.
    •Los cambios en el daño inducido por la radiación UV en el ADN y la capacidad de reparación desde el día 0 hasta el día 76 o la visita de finalización prematura (si procede) medidos a través del análisis de los fotoproductos UV y los mecanismos de reparación del ADN de la piel tratada con radiación en comparación con la piel no tratada;
    •El cambio en la gravedad de la enfermedad cutánea desde el cribado/día -1/día 0 hasta los días 70, 75 o 76 o la visita de finalización prematura (si procede), y 238(±14), medido según:
    Escala IGA de 5 puntos;
    Escala de tipo Likert de 11 puntos;
    •El cambio en la gravedad de la enfermedad cutánea desde el cribado/día -1/día 0 hasta los días 75 o 76 o la visita de finalización prematura (si procede) y 238(±14), medido según el índice europeo de gravedad de la XP;
    •El cambio en la densidad de melanina desde el inicio (día -1 o 0) hasta los días 28, 56, 75 o 76 o la visita de finalización prematura (si procede), y 238(±14), medido por espectrofotometría.
    •El cambio en la calidad de vida desde el cribado/día -1/día 0 hasta los días 70, 75 o 76 o la visita de finalización prematura (si procede), y 238(±14), medido con dos instrumentos:
    WPAI:GH
    QOLEB adaptado a XP
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see above.
    Por favor vea arriba.
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    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: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6
    F.4.2.2In the whole clinical trial 6
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-23
    P. End of Trial
    P.End of Trial StatusOngoing
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