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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-001419-10
    Sponsor's Protocol Code Number:CUV152
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2025-01-06
    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 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)
    Étude Preuve de Concept, Phase IIa, Ouverte, Evaluant la Sécurité et l’Efficacité de l’Implant sous-Cutané d’Afamélanotide chez les Patients Atteints de Xeroderma Pigmentosum C et V (XPC et XPV)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the safety and efficacy of the photoprotective drug, afamelanotide in patients with Xeroderma Pigmentosum C and V
    Étude évaluant la sécurité et l’efficacité de l’afamélanotide, médicament photoprotecteur chez les patients atteints de Xeroderma Pigmentosum C et V (XPC et XPV)
    A.3.2Name or abbreviated title of the trial where available
    Phase IIa XPC and XPV Study
    Etude XPC et XPV Phase IIa
    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 pointJessica Nucci
    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+447766111539
    B.5.5Fax number+35319010172
    B.5.6E-mailjessica.nucci@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.3.8 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 name[Nle4, D-Phe7]-α-Melanocyte Stimulating Hormone
    D.3.9.4EV Substance CodeSUB33758
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    Patients with Xeroderma Pigmentosum C and V
    Patients atteints de Xeroderma Pigmentosum C et V
    E.1.1.1Medical condition in easily understood language
    Patients with Xeroderma Pigmentosum C and V
    Patients atteints de Xeroderma Pigmentosum C et 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.
    •Évaluer l’impact de l’afamélanotide sur la dose minimale érythémale (DME) chez les patients atteints de XPC.
    •Évaluer l’impact de l’afamélanotide sur la DME chez les patients atteints de 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 and XPV.
    •Evaluate the impact of afamelanotide on melanin density in patients with XPC and 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 and XPV.
    •Evaluate the impact of afamelanotide on the quality of life of patients with XPC and XPV.
    • Évaluer l’impact de l’afamélanotide sur les dommages de l’ADN induits par les UV et la capacité de réparation chez les patients atteints de XPC et XPV.
    • Évaluer l’impact de l’afamélanotide sur la densité de mélanine chez les patients atteints de XPC et XPV.
    • Évaluer l’innocuité et la tolérabilité de l’afamélanotide chez les patients atteints d’XPC et XPV.
    • Évaluer l’impact de l’afamélanotide sur la severité de la maladie cutanée des patients atteints de XPC et XPV.
    • Évaluer l’impact de l’afamélanotide sur la qualité de vie des patients atteints de XPC et 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.
    -Affiliated to a French “Sécurité Sociale” scheme.
    -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.
    - Patient de sexe masculin ou féminin avec un diagnostic de XPC ou XPV confirmé génétiquement ou de façon moléculaire.
    - Agé de 18 à 75 ans.
    - Affiliation obligatoire à un régime de sécurité sociale.
    - Fournir un consentement éclairé écrit avant l’exécution de toute procédure spécifique à l’étude.
    - Disposé et capable de se conformer aux conditions spécifiées dans le protocole et les procédures de l’étude, selon l’avis de l’investigateur.
    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 highly effective contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device), 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 Visit 0 (Day -1);
    •Participation in a clinical trial for an investigational agent within 30 days prior to Visit 0 (Day -1);
    •Not suitable for trial participation in the opinion of the Investigator.
    - Allergie connue à l’afamélanotide ou au polymère contenu dans l’implant.
    - Présence d’une maladie hépatique grave ou d’une insuffisance hépatique.
    - Insuffisance rénale.
    - Toute autre condition médicale pouvant interférer avec le protocole de l’étude.
    - Mélanome présent.
    - Femme enceinte (confirmée par un test de grossesse urinaire β-HCG positif) ou allaitante.
    - Les femmes en âge de procréer (pré-ménopausées, non stériles chirurgicalement) n’utilisant pas de mesures contraceptives adéquates (c.-à-d. contraceptifs oraux, diaphragme plus spermicide, dispositif intra-utérin) ou un mode de vie excluant la grossesse, jusqu’à trois mois après la dernière administration d’implant.
    - Homme sexuellement actif avec des partenaires en âge de procréer (pré-ménopausée, non stériles chirurgicalement) qui n’utilisent pas de mesures contraceptives adéquates, comme décrit ci-dessus.
    - Utilisation de tout autre traitement antérieur et concomitant susceptible d’interférer avec l’objectif de l’étude, dans les 30 jours précédant la visite 0.
    - Participation à un essai clinique pour un agent expérimental dans les 30 jours précédant la visite 0.
    - Ne convient pas à la participation de l'essai selon l'avis de l'investigateur.
    E.5 End points
    E.5.1Primary end point(s)
    The change in MED
    Le changement de 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, the Day after Day 75±3.
    L’analyse comparera l’augmentation individuelle de la DEM entre le jour 0 et l’évaluation post-traitement, le lendemain du jour 75±3.
    E.5.2Secondary end point(s)
    • The changes in UV-induced DNA damage and repair capacity from baseline Day 0 to the day after Day 75±3, as measured through analysis of UV photoproducts and DNA repair mechanisms of irradiated skin in comparison with non-irradiated skin (refer to Biopsy Protocol for details).
    • The change in skin disease severity from Screening/Day -1/Day 0 to Day 70±3, Day 75±3 or day after or Premature Termination Visit (if applicable) and Day 238±14 as measured by:
    o 5-point IGA scale;
    o 11-point Likert-type scale;
    • The change in (skin) disease severity from Screening/Day -1/Day 0 to Day 75±3 or day after 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±3, 56±3, 75±3 or day after or Premature Termination Visit (if applicable) and 238±14 as measured by spectrophotometry.
    • The change in Quality of Life from Screening/Day -1/Day 0 to Day 70±3, 75±3 or day after, or Premature Termination Visit (if applicable) and 238±14, as measured by the two instruments:
    o WPAI:GH
    o XP-derived QOLEB
    • Les changements dans les dommages de l’ADN induits par les UV et la capacité de réparation entre le jour 0 et le lendemain du jour 75±3, tels que mesurés par l’analyse des photoproduits UV et des mécanismes de réparation de l’ADN sur des échantillons de peau prélevés sur une zone exposée aux UV par rapport à des échantillons de peau prélevés sur une zone non exposée aux UV (voir le protocole de biopsie pour plus de détails).
    • Le changement de la sévérité de la maladie cutanée entre le jour de la visite de sélection/jour -1/jour 0 et les jours 70±3, 75±3 ou le lendemain ou visite d’interruption prématurée (le cas échéant) et 238±14, mesuré par :
    o Échelle IGA à 5 points ;
    o Échelle de type Likert à 11 points ;
    • Le changement de la sévérité de la maladie (cutanée) entre le jour de la visite de sélection/jour -1/jour 0 et les jours 75±3 ou le lendemain ou le jour de la visite d’interruption prématurée (le cas échéant) et 238±14, tel que mesuré par le score de sévérité XP européen;
    • Le changement de la densité de mélanine entre le jour de la visite de sélection/jour -1/jour 0 et les jours 28±3, 56±3, 75±3 ou le lendemain ou la visite d’interruption prématurée (le cas échéant) et 238±14 mesuré par spectrophotométrie.
    • Le changement de la qualité de vie des patients entre le jour de la visite de sélection/jour -1/jour 0 et les jours 70±3, 75±3 ou le lendemain, ou de la visite d’interruption prématurée (le cas échéant) et 238±14, tel que mesuré par les deux instruments :
    o WPAI:GH
    o QOLEB dérivé de XP
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see above.
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 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 du dernier participant
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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 state4
    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
    Non prévu pour l’instant.
    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 Decision2023-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2024-11-18
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