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    Summary
    EudraCT Number:2010-022921-13
    Sponsor's Protocol Code Number:AUX-CC-802
    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:2012-01-05
    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 number2010-022921-13
    A.3Full title of the trial
    A Phase 3, open-label study of the safety and effectiveness of AA4500 administered twice per treatment cycle for up to four treatment cycles (2 x 4) in men with Peyronie’s disease
    Studio di Fase 3, in aperto, sulla sicurezza ed efficacia di AA4500 somministrato due volte per ciclo di trattamento fino ad un massimo di quattro cicli di trattamento (2 x 4) ad uomini con la malattia di La Peyronie.
    A.3.2Name or abbreviated title of the trial where available
    Assessment of AA4500 in Men with Peyronie’s disease
    Valutazione di AA4500 nella malattia di Peyronie
    A.4.1Sponsor's protocol code numberAUX-CC-802
    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 SponsorAUXILIUM UK LIMITED
    B.1.3.4CountryUnited Kingdom
    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 supportAUXILIUM UK Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDimensione Ricerca S.r.l.
    B.5.2Functional name of contact pointRegulatory Approval Department
    B.5.3 Address:
    B.5.3.1Street AddressViale Parioli 12
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00197
    B.5.3.4CountryItaly
    B.5.4Telephone number06-8076072
    B.5.5Fax number06-80693521
    B.5.6E-mailinfo@dimensione-ricerca.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 nameCollagenase clostridium histolyticum
    D.3.2Product code AA4500
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcollagenase clostridium histolyticum
    D.3.9.2Current sponsor codeAA4500
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number.58
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typemicrobial derived biologic product
    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
    Peyronie's disease
    Malattia di La Peyronie
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10034765
    E.1.2Term Peyronie's disease
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this study are to assess the safety and effectiveness of AA4500 in men with Peyronie’s disease.
    Gli obiettivi dello studio consistono nella valutazione della sicurezza e dell’efficacia di AA4500 in uomini affetti da malattia di La Peyronie.
    E.2.2Secondary objectives of the trial
    The change from baseline in severity of Peyronie’s disease physical and psychological symptom domain (PDQ questions 1-6), the change from baseline in the penile pain domain (PDQ questions 7-9), the responder analysis based on subject global assessment, the change from baseline in overall satisfaction domain of the IIEF, the change from baseline in penile plaque consistency, and the change from baseline in penile length will be summarized with descriptive statistics at each evaluation window.
    Le variazioni rispetto al baseline della gravita' dei sintomi fisici e psicologici causati dalla malattia di La Peyronie (domande 1-6 del PDQ), la variazione rispetto al baseline del dominio dolore penieno (domande 7-9 del PDQ), l’analisi dei soggetti che rispondono al trattamento (responder) in base alla valutazione soggettiva globale, la variazione rispetto al baseline del dominio soddisfazione globale relativa all’IIEF (Indice Internazionale della Funzione Erettile), la variazione rispetto al baseline della consistenza della placca peniena, e la variazione rispetto al baseline della lunghezza del pene saranno riassunti con statistiche descrittive ad ogni finestra di valutazione.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Be a male and be ≥ 18 years of age 2. Be in a stable relationship with a female partner/spouse for at least 3 months before screening and be willing to have vaginal intercourse with that partner/spouse 3. Have symptom(s) of Peyronie’s disease for at least 12 months before the first dose of study drug and have evidence of stable disease as determined by the investigator 4. Have penile curvature of at least 30° in the dorsal, lateral, or dorsal/lateral plane at screening. It must be possible to delineate the single plane of maximal curvature for evaluation during the study 5. Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile 6. Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). The subject must also sign an authorization form to allow disclosure of his protected health information (PHI). The PHI authorization form and informed consent form may be an integrated form or may be separate forms depending on the institution 7. Be able to read, complete and understand the various rating instruments in English or the appropriate local language for the country in which the study is being performed.
    1. Essere di sesso maschile ed avere almeno 18 anni di eta'. 2. Avere una relazione stabile con un partner di sesso femminile/ coniuge, iniziata da almeno tre mesi prima dello screening ed essere disposti ad avere rapporti sessuali vaginali con tale partner/ coniuge. 3. Presentare sintomi della malattia di La Peyronie con insorgenza di almeno 12 mesi prima della la prima dose del farmaco sperimentale, e presentare evidenza di malattia stabile a giudizio dello sperimentatore. 4. Presentare un incurvamento penieno di almeno 30° sul piano dorsale, laterale o dorsolaterale al momento dello screening. Deve essere possibile delineare il singolo piano di massimo incurvamento ai fini della valutazione nel corso dello studio. 5. Essere giudicato in buona salute sulla base dei risultati di un’anamnesi, esame fisico e il profilo di laboratorio. 6. Firmare e datare volontariamente un accordo di consenso in formato approvato Comitato Etico Indipendente (IRB/IEC). I soggetti inoltre dovranno firmare un modulo di autorizzazione allo scopo di permettere la divulgazione dei propri dati sanitari riservati (PHI). Il modulo di autorizzazione dei PHI e il modulo di consenso informato possono essere integrati in un unico modulo o possono essere separati, a seconda della scelta dell’istituzione. 7. Essere in grado di leggere, completare e comprendere i vari strumenti di valutazione (rating) in inglese o nella lingua nazionale del paese nel quale si svolge lo studio.
    E.4Principal exclusion criteria
    A subject will be excluded from study participation if he: 1.Has a penile curvature of less than 30° or greater than 90° at the screening visit,2.Has any of the following conditions:Chordee in the presence or absence of hypospadias,Thrombosis of the dorsal penile artery and/or vein,Infiltration by a benign or malignant mass resulting in penile curvature,Infiltration by an infectious agent, such as lymphogranuloma venereum,Ventral curvature from any cause,Presence of an active sexually transmitted disease,Known active hepatitis B or C,Known immune deficiency disease or be positive for human immunodeficiency virus (HIV);3.Has previously undergone surgery for Peyronie’s disease;4.Fails to have an erection after administration of prostaglandin E1 or trimix;5.Has a calcified plaque that would prevent proper injection of study medication;6.Has an isolated hourglass deformity of the penis;7.Has the plaque causing curvature of the penis located proximal to the base of the penis, so that the injection of the local anesthetic would interfere with the injection of AA4500 into the plaque;8.Has previously received alternative medical therapies for Peyronie’s disease administered by the intralesional route within 3 months before the first dose of study drug;9.Has received alternative medical therapies for Peyronie’s disease administered by the oral or topical routes within 3 months before the first dose of study drug;10. Has had extracorporeal shock wave therapy (ESWT) for the correction of Peyronie’s disease within the 6-month period before screening;11.Has used any mechanical type device for correction of Peyronie’s disease within the 2-week period before screening;12.Has used a mechanical device to induce a passive erection within the 2-week period before screening;13.Has significant erectile dysfunction that has failed to respond to oral treatment with phosphodiesterase type 5 (PDE5) inhibitors;14.Has a penile Duplex Doppler ultrasound evaluation at screening that shows compromised penile hemodynamics;15.Has uncontrolled hypertension, as determined by the investigator;16.Has a known recent history of stroke, bleeding, or other significant medical condition, which in the investigator’s opinion would make the subject unsuitable for enrollment in the study;17.Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits;18.Has received an investigational drug or treatment within 30 days before the first dose of study drug, except for subjects who receive one treatment cycle of AA4500 in Study AUX-CC-805;19.Has a known systemic allergy to collagenase or any other excipient of AA4500;20.Has a known allergy to any concomitant medication required as per the protocol; 21.Has received anticoagulant medication (except for ≤ 165 mg aspirin daily or ≤ 800 mg of over-the-counter NSAIDS daily) during the 7 days before each dose of study drug; 22.Has received any collagenase treatments within 30 days of the first dose of study drug, except for subjects who receive one treatment cycle of AA4500 in Study AUX-CC-805; 23.Has, at any time, received AA4500 for the treatment of Peyronie’s disease, except for subjects who receive one treatment cycle of AA4500 in Study AUX-CC-805
    Un soggetto verra' escluso dalla partecipazione allo studio, se: 1.Presenti un incurvamento penieno inferiore a 30°o superiore a 90° alla visita di screening;2.Presenti una delle condizioni seguenti:Griposi (chordee) in presenza o assenza di ipospadia,Trombosi dell’arteria e/o vena dorsale peniena,Formazione infiltrante benigna o maligna che causi incurvamento penieno,Infiltrazione di agenti infettivi come il lymphogranuloma venereum,Incurvamento ventrale da qualsiasi causa,Presenza di malattia sessualmente trasmessa,Epatite B o C attiva nota,Patologia immunodeficitaria nota o positivita' per il virus dell’immunodeficienza umana (HIV);3.Pregressa chirurgia per malattia di La Peyronie;4.Impossibilita' di ottenere un’erezione a seguito di somministrazione di prostaglandina E1 o trimix;5.Presenza di placca calcificata che impedisca la somministrazione iniettiva del farmaco sperimentale;6.Deformita' peniena a clessidra isolata;7.Placca che causi un incurvamento penieno localizzata in posizione prossimale rispetto alla base del pene, cosicche' l’iniezione di anestetico locale interferisca con l’iniezione di AA4500 nella placca;8. Pregressa terapia medica alternativa per malattia di Peyronie con somministrazione intralesionale entro i 3 mesi precedenti la prima dose di farmaco sperimentale;9. Pregressa terapia medica alternativa per malattia di La Peyronie per somministrazione orale o per applicazione locale entro i 3 mesi precedenti la prima dose di farmaco sperimentale;10.Terapia extracorporea a onde d’urto (ESWT) per la correzione della malattia di La Peyronie effettuata nei 6 mesi precedenti allo screening;11.Uso di qualsiasi dispositivo meccanico per la correzione della malattia di La Peyronie nelle 2 settimane precedenti allo screening;12.Uso di dispositivi meccanici per l’induzione di un’erezione passiva nelle 2 settimane precedenti allo screening;13.Disfunzione erettile significativa dimostratasi refrattaria a terapia orale con inibitori della fosfodiesterasi di tipo 5 (PDE5);14.Valutazione con Duplex Doppler effettuata allo screening che evidenzi un’emodinamica peniena compromessa;15.Ipertensione non controllata secondo la valutazione dello sperimentatore;16.Anamnesi recente con storia di ictus, emorragia nota o altre patologie significative, che a giudizio dello sperimentatore rendano il soggetto inidoneo all’arruolamento nello studio;17. Indisponibilita' o incapacita' di collaborare con i requisiti dello studio, incluso il completamento di tutte le visite programmate; 18.Somministrazione di farmaci o terapie sperimentali nei 30 giorni precedenti alla prima dose del farmaco sperimentale, ad eccezione dei soggetti che ricevono un ciclo di trattamento con AA4500 nel quadro dello studio AUX-CC-805;19.Allergia sistemica nota a collegenase o altri eccipienti di AA4500;20.Allergia nota ad altri farmaci concomitanti previsti dal protocollo;21.Assunzione di farmaci anticoagulanti durante i 7 giorni precedenti ciascuna dose del farmaco sperimentale;22.Trattamenti con collagenase entro i 30 giorni precedenti alla prima dose del farmaco sperimentale, ad eccezione dei soggetti che ricevono un ciclo di trattamento con AA4500 nel quadro dello studio AUX-CC-805;23.Assunzione, in qualsiasi momento, di AA4500 per il trattamento della malattia di La Peyronie, ad eccezione dei soggetti che ricevono un ciclo di trattamento con AA4500 nel quadro dello studio AUX-CC-805.
    E.5 End points
    E.5.1Primary end point(s)
    The change from baseline in the Peyronie’s disease bother domain (PDQ questions 10-15) and the percent improvement from baseline in penile curvature will be summarized with descriptive statistics at each evaluation window.
    La variazione rispetto al baseline nel dominio disagio causato dalla malattia di La Peyronie (domande 10-15 del PDQ) e il miglioramento percentuale rispetto al baseline dell’incurvamento penieno saranno riassunti con statistiche descrittive ad ogni finestra di valutazione.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.3.1Comparator description
    non esiste confronto
    E.8.2.4Number of treatment arms in the trial1
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    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 months18
    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 months19
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 300
    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 Decision2011-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-10
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