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    Summary
    EudraCT Number:2013-004562-33
    Sponsor's Protocol Code Number:HHD_SCENESSE
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-11-18
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-004562-33
    A.3Full title of the trial
    PHASE II STUDY TO EVALUATE SAFETY AND EFFICACY OF A BIO-RIASSORBABLE SUBCUTANEOUS IMPLANT OF AFAMELANOTIDE IN HAILEY-HAILEY DISEASE (HHD) PATIENTS
    Studio, di fase II, per valutare la sicurezza e l’efficiacia di un impianto sotto-cutaneo bio-riassorbibile di Afamelanotide in pazienti affetti da Hailey-Hailey Disease (HHD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PHASE II STUDY TO EVALUATE SAFETY AND EFFICACY OF A BIO-RIASSORBABLE SUBCUTANEOUS IMPLANT OF AFAMELANOTIDE IN HAILEY-HAILEY DISEASE (HHD) PATIENTS
    Studio, di fase II, per valutare la sicurezza e l’efficiacia di un impianto sotto-cutaneo bio-riassorbibile di Afamelanotide in pazienti affetti da Hailey-Hailey Disease (HHD)
    A.4.1Sponsor's protocol code numberHHD_SCENESSE
    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 SponsorISTITUTI FISIOTERAPICI OSPITALIERI
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportISTITUTI FISIOTERAPICI OSPITALIERI
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTI FISIOTERAPICI OSPITALIERI
    B.5.2Functional name of contact pointGIANFRANCO BIOLCATI
    B.5.3 Address:
    B.5.3.1Street AddressVIA ELIO CHIANESI 53
    B.5.3.2Town/ cityROME
    B.5.3.3Post code00144
    B.5.3.4CountryItaly
    B.5.6E-mailbiolcati@ifo.it
    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
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameSCENESSE
    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
    SYMPTOMATIC HHD PATIENTS
    PAZIENTI SINTOMATICI PER MALATTIA DI HAILEY-HAILEY
    E.1.1.1Medical condition in easily understood language
    EROSIONS, BULLAE, SCARS IN DIFFERENT PART OF THE SKIN
    EROSIONI, BOLLE E CROSTE IN VARIE PARTI DELLA CUTE
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10019029
    E.1.2Term Hailey-Hailey disease
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    REDUCE AND IMPROVE SYMPTOMS IN HHD PATIENTS
    L’obiettivo primario dello studio è di stabilire se l’afamelanotide può ridurre o eliminare i sintomi in pazienti affetti da HHD.
    E.2.2Secondary objectives of the trial
    IMPROVE QUALITY OF LIFE
    REDUCE SEVERITY OF SYMPTOMS
    EVALUATE SAFETY OF AFAMELANOTIDE
    Gli obiettivi secondari sono:
    - Migliorare la qualità di vita dei pazienti affetti da HHD
    - Ridurre la severità dei sintomi in pazienti affetti da HHD
    - Valutare la sicurezza e la tollerabilità degli impianti di Afamelanotide
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    MALE AND FEMALE WITH A CLINICAL/HISTOLOGICAL/GENETIC DIAGNOSIS OF HHD
    AN AREA INDEX SCORE >2
    AGE FROM 18 TO 80 YEARS
    SIGNED CONSENT FORM
    - Soggetti di sesso maschile o femminile con sintomi caratteristici di HHD con una diagnosi clinica / istologica e geneticamente confermata di HHD.
    - Avere una diagnosi clinicamente confermata, stabile (senza remissione recente documentata entro 30 giorni prima della visita di screening) con Area Index Score che dovrà essere > 2.
    - Età dai 18 anni a 80 anni al momento del consenso.
    - In grado di comprendere e firmare il modulo di consenso informato scritto.
    E.4Principal exclusion criteria
    ALLERGY TO AFAMELANOTIDE
    HISTORY OF MELANOMA, BOWEN DISEASE, SQUAMOUS CELL CARCINOMA
    PREGNANCY
    NOT USE OF CONTRACTCEPTIVE
    - Allergia all’afamelanotide o il polimero contenente l'impianto o lidocaina o altri anestetici locali da utilizzare durante la somministrazione del farmaco in studio
    - Storia personale di melanoma o di sindrome del nevo displastico.
    - La malattia di Bowen corrente, carcinoma basocellulare, il carcinoma a cellule squamose, o altre lesioni cutanee maligne o pre-maligne.
    - Femmina che è incinta (confermata da test di gravidanza β-HCG positivo prima del basale) o in allattamento.
    - Le donne in età fertile (pre-menopausa, non chirurgicamente sterili) e gli uomini in grado di avere figli (la cui partner è potenzialmente fertile) che non usano misure contraccettive adeguate (per esempio contraccettivi orali, diaframma più spermicida, dispositivo intrauterino).
    E.5 End points
    E.5.1Primary end point(s)
    DIFFERENCE BETWEEN T0 AND 12 MONTHS USING HHDAIS
    L’endpoint primario di questo studio sarà la differenza nelle valutazioni basale e a 12 mesi mediante la scala di valutazione della HHDAIS
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 MONTHS
    12 MESI
    E.5.2Secondary end point(s)
    VARIAITON IN HHDAIS AND WEIGHTING SCORE
    HEMATOLOGICAL PARAMETERS
    ADVERSE EVENTS
    Valutazione ad ogni visita dell’andamento della scala di valutazione HHDAIS e del Weighting score.
    Valutazione ad ogni visita delle variazioni dei parametri clinici ed ematologici registrati Valutazione ad ogni visita degli eventi avversi
    E.5.2.1Timepoint(s) of evaluation of this end point
    MONTHLY
    MENSILMENTE
    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.8.2.4Number of treatment arms in the trial1
    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 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
    ULTIMA VISITA DELL'ULTIMO PAZIENTE
    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
    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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.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
    NESSUNA
    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 Decision2013-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-12
    P. End of Trial
    P.End of Trial StatusOngoing
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