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    Summary
    EudraCT Number:2011-000169-10
    Sponsor's Protocol Code Number:CUV101
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-05
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-000169-10
    A.3Full title of the trial
    A Phase II, Randomised Pilot Study to Evaluate the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo
    Studio pilota di Fase II randomizzato, finalizzato alla valutazione dell`™ efficacia e sicurezza degli impianti sottocutanei bioriassorbibili di afamelanotide e della luce ultravioletta B a banda stretta (NB-UVB) nel trattamento dei pazienti affetti da vitiligine non segmentale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    N/A
    n/A
    A.3.2Name or abbreviated title of the trial where available
    Phase II Vitiligo Pilot Study
    Studio Pilota di Fase II sulla Vitiligine
    A.4.1Sponsor's protocol code numberCUV101
    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 PHARMACUETICALS LTD.
    B.1.3.4CountryAustralia
    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 Pharmaceuticals Ltd
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinuvel Pharmaceuticals Ltd
    B.5.2Functional name of contact pointClinical department
    B.5.3 Address:
    B.5.3.1Street AddressNeuhofstrasse 3d
    B.5.3.2Town/ cityBaar
    B.5.3.3Post code6340
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41 41 767 4545
    B.5.5Fax number+41 41 767 4546
    B.5.6E-mailmanfred.reim@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
    D.3.2Product code CUV1647
    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.3.9.2Current sponsor codeCUV1647
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    Subjects affected by non-segmental vitiligo
    Soggetti affetti da vitiligine non-segmentata
    E.1.1.1Medical condition in easily understood language
    N/A
    N/A
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10062080
    E.1.2Term Pigmentation disorder
    E.1.2System Organ Class 10040785 - Skin and subcutaneous 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 efficacy of afamelanotide implants and NB-UVB light in the treatment of nonsegmental vitiligo
    Valutare l’efficacia degli impianti di afamelanotide e della luce NB-UVB nel trattamento della vitiligine non segmentale
    E.2.2Secondary objectives of the trial
    • To determine the short-term safety of both treatments in patients with nonsegmental vitiligo • To evaluate the maintenance of pigmentation achieved with both treatments in patients with nonsegmental vitiligo
    • Determinare la sicurezza a breve termine di entrambi i trattamenti nei pazienti affetti da vitiligine non segmentale • Valutare il mantenimento della pigmentazione ottenuta con entrambi i trattamenti nei pazienti affetti da vitiligine non segmentale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male and female subjects with a confirmed diagnosis of nonsegmental vitiligo with 15% to 50% of total body surface involvement •Stable or slowly progressive vitiligo over a 3-month period •Aged 18 or more •Fitzpatrick skin types III-VI •Willing and able to comply with the conditions specified in this protocol and study procedures in the opinion of the Investigator •Providing written Informed Consent prior to the performance of any study-specific procedure
    • Soggetti maschi e femmine con diagnosi confermata di vitiligine non segmentale su una percentuale del corpo compresa fra il 15% e il 50% della superficie totale • Vitiligine stabile o in lento avanzamento in un periodo di 3 mesi • Eta` non inferiore a 18 anni • Tipo di pelle Fitzpatrick III-VI • Pazienti disponibili e in grado di ottemperare alle condizioni richieste per il presente protocollo e alle procedure previste dallo studio, a giudizio dello sperimentatore • Consenso informato scritto, ottenuto prima che venga eseguita qualsiasi procedura specifica prevista nell’ambito dello studio
    E.4Principal exclusion criteria
    •Fitzpatrick skin types I-II •Vitiligo involving the hands and feet only •Extensive leukotrichia, in the opinion of the Investigator •Vitiligo of more than 5 years duration • Previous treatment with NB-UVB within 6 months prior to the Screening Visit • Patient not responsive to previous NB-UVB treatment, defined as a patient who has undergone at least 30 NB-UVB sessions with no or minimal clinically relevant pigmentary response, in the opinion of the Investigator •Allergy to afamelanotide or the polymer contained in the implant or to lignocaine/lidocaine or other local anaesthetic to be used during the administration of the implant •Previous treatment with topical immunomodulators (corticosteroids, calcineurin inhibitors) for vitiligo within 4 weeks prior to the Screening Visit •History of photosensitivity disorders •Claustrophobia •History of photosensitive lupus •Any active and/or unstable autoimmune disease judged to be clinically significant by the Investigator • Any disorder associated with an immune deficiency eg infections with EBV or CMV • Diagnosed with HIV/AIDS, or Hepatitis B or C •History of melanoma or lentigo maligna • Patients with a family history of melanoma in a first degree relative •History of dysplastic nevus syndrome • History of malignant or pre-malignant skin lesions • Patients with a large number of nevi or patients having more than 5 atypical nevi •Any skin disease that may interfere with the study evaluation •Any evidence of organ dysfunction or deviation from normal in clinical or laboratory determinations judged to be clinically significant by the Investigator •History of systemic or psychiatric disease judged to be clinically significant by the Investigator and which may interfere with the study evaluation •Female who is pregnant (confirmed by positive β-HCG pregnancy test) or lactating •Female of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device) during the trial and for a period of three months thereafter •Sexually active man with a partner of child-bearing potential not using barrier contraception during the trial and for a period of three months hereafter •Participation in a clinical trial for an investigational agent within 30 days prior to the Screening Visit •Use of any prior and concomitant therapy which may interfere with the objective of the study, including drugs that cause photosensitivity or skin pigmentation within 60 days prior to the Screening Visit •Subjects assessed as not suitable for the study in the opinion of the Investigator
    • Tipo di pelle Fitzpatrick I-II • Vitiligine riguardante solo mani e piedi • Leucotrichia estesa, a giudizio dello sperimentatore • Vitiligine da oltre 5 anni · Trattamento precedente con NB-UVB entro 6 mesi prima della visita di screening · Pazienti che non hanno risposto al trattamento precedente con NB-UVB, definiti come pazienti che sono stati trattati con almeno 30 sessioni di NB-UVB con o senza minimo · di risposta pigmentaria clinicamente rilevanti a giudizio dello sperimentatore • Allergia all’afamelanotide o al polimero contenuto nell’impianto, oppure alla lignocaina/lidocaina o ad altri anestetici locali utilizzati durante la somministrazione dell’impianto • Precedente trattamento della vitiligine con immunomodulatori topici (corticosteroidi, inibitori della calcineurina) nelle 4 settimane precedenti la visita di screening • Anamnesi di disturbi relativi alla fotosensibilita` • Claustrofobia • Anamnesi di lupus con fotosensibilita` · Qualsiasi disturbo associato ad un deficit immunitario ad esempio con EBV o infezioni da CMV · Diagnosi di HIV/AIDS, o epatite B o C • Qualsiasi patologia autoimmune attiva e/o instabile, ritenuta clinicamente significativa dallo sperimentatore • Anamnesi di melanoma o lentigo maligna • Anamnesi di sindrome del nevo displasico · I pazienti con una storia familiare di melanoma in un parente di primo grado · Qualsiasi Storia di lesioni lesione cutaneacutanee di natura maligna o pre-maligna · I pazienti con un elevato numero di nevi o di pazienti aventi più di 5 nevi atipici • Qualsiasi patologia cutanea in grado di interferire con la valutazione dello studio • Qualsiasi traccia di disfunzione degli organi o deviazione dalla norma rilevata nei riscontri di laboratorio e ritenuta clinicamente significativa dallo sperimentatore • Anamnesi di patologia sistemica o psichiatrica ritenuta clinicamente significativa dallo sperimentatore e in grado di interferire con la valutazione dello studio • Pazienti in stato interessante (confermato dalla positivita` del test di gravidanza β-HCG) o con allattamento al seno in corso • Pazienti di sesso femminile in eta` fertile (premenopausali, non chirurgicamente sterili) che non utilizzano metodi contraccettivi adeguati (es. contraccettivi orali, profilattico, diaframma con spermicida, IUD) durante la sperimentazione e per un successivo periodo di tre mesi • Pazienti di sesso maschile sessualmente attivi con partner in eta` potenzialmente fertile che non sono disponibili a utilizzare contraccettivi di barriera durante la sperimentazione e nei 3 mesi successivi • Partecipazione a uno studio clinico con un altro farmaco sperimentale nei 30 giorni precedenti la visita di screening • Utilizzo di qualsiasi terapia precedente e concomitante in grado di interferire con l’obiettivo dello studio, compresi farmaci che causano fotosensibilita` o pigmentazione della pelle, entro i 60 giorni precedenti la visita di screening • Soggetti ritenuti non adatti allo studio a giudizio dello sperimentatore
    E.5 End points
    E.5.1Primary end point(s)
    The time to onset of repigmentation of full body, face, trunk and extremities from Day 0 to Day 168 between the two treatment groups. H0: there will be no difference in the time to onset of repigmentation of full body, face, trunk and extremities between the two treatment groups. The primary efficacy endpoint will be analyzed as soon as Day 168 data become available.
    Tempo necessario per la ripigmentazione dell’intero corpo, faccia, tronco ed estremita`, dal giorno 0 al giorno 168, rilevato sui due gruppi di trattamento; H0: non esistera` alcuna differenza di tempo necessario per la ripigmentazione dell’intero corpo, faccia, tronco ed estremita`, rilevato sui due gruppi di trattamento. L’endpoint di efficacia principale sara` analizzato non appena saranno disponibili i dati del giorno 168.
    E.5.1.1Timepoint(s) of evaluation of this end point
    from Day 0 to Day 168
    dal giorno 0 al giorno 168
    E.5.2Secondary end point(s)
    Change from Day 0 to Day 168 between each treatment group in: • The pigmentation of full body, face, trunk and extremities • The patient’s quality of life Change from Day 168 to Days 224, 280 and 336 between each treatment group in: • The pigmentation of full body, face, trunk and extremities
    Cambiamento dal giorno 0 al giorno 168 per ogni gruppo di trattamento in: · Pigmentazione dell’intero corpo, faccia, tronco ed estremita' · Qualita' della vita del paziente · Identificazione di melanina, melanociti · Cambiamento dal giorno 168 ai giorni 224, 280 e 336 per ogni gruppo di trattamento in: · Pigmentazione dell’intero corpo, faccia, tronco ed estremita'
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change from Day 0 to Day 168 between each treatment group in: • The pigmentation of full body, face, trunk and extremities • The patient’s quality of life Change from Day 168 to Days 224, 280 and 336 between each treatment group in: • The pigmentation of full body, face, trunk and extremities
    Cambiamento dal giorno 0 al giorno 168 per ogni gruppo di trattamento in: · Pigmentazione dell’intero corpo, faccia, tronco ed estremita' · Qualita' della vita del paziente · Identificazione di melanina, melanociti · Cambiamento dal giorno 168 ai giorni 224, 280 e 336 per ogni gruppo di trattamento in: · Pigmentazione dell’intero corpo, faccia, tronco ed estremita'
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    phototherapy only vs. drug+phototherapy
    phototherapy only vs. drug+phototherapy
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1
    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
    Switzerland
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months15
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months15
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 60
    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)
    At the end of the study the patients will be treated with the usual treatment for non-sequental vitiligo
    trattamento usuale per la vitiligine segmentale non
    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 Decision2011-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-12-05
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