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    Summary
    EudraCT Number:2013-005384-66
    Sponsor's Protocol Code Number:AUX-CC-807
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-04-11
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-005384-66
    A.3Full title of the trial
    A phase 3b, open-label pilot study to evaluate the safety and effectiveness of up to four treatment cycles of AA4500 in combination with the ErecAid® Esteem® Manual Vacuum Therapy System in men with Peyronie’s disease.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of AA4500 in combination with Erecaid Esteem Manual Vacuum Therapy System in men with Peyronie's Disease
    A.3.2Name or abbreviated title of the trial where available
    Safety and Efficacy of AA4500 in men with Peyronie's Disease
    A.4.1Sponsor's protocol code numberAUX-CC-807
    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 SponsorEndo Ventures 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 supportEndo Ventures Limited
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEndo Ventures Limited
    B.5.2Functional name of contact pointDirector, Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressFirst Floor, Minerva House, Simmonscourt Road
    B.5.3.2Town/ cityBallsbridge
    B.5.3.3Post codeDublin 4
    B.5.3.4CountryIreland
    B.5.4Telephone number+353 1 268 2017
    B.5.5Fax number+353 1 268 2030
    B.5.6E-mailWalsh.Ciara@endo.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 Yes
    D.2.1.1.1Trade name Xiapex
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum AB
    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 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 solution 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.3.9.3Other descriptive namecollagenase clostridium histolyticum
    D.3.9.4EV Substance CodeSUB31009
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    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 biological
    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
    E.1.1.1Medical condition in easily understood language
    Peyronie's disease is caused by scar tissue along the length of the penis, causing the penis to bend on erection.
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    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 combination with the ErecAid® Esteem® Manual Vacuum Therapy System in improving curvature deformity in men with Peyronie’s disease.
    E.2.2Secondary objectives of the trial
    The secondary objectives will be captured as a change from baseline in the Peyronie’s disease bother domain (PDQ questions 10-15), 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
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    No subject will be enrolled until all eligibility criteria have been satisfied. To qualify for the study a subject must:
    1. Be a male ≥18 years of age
    2. Have symptom(s) of Peyronie's disease and have evidence of stable disease as determined by the investigator
    3. 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
    4. Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile
    5. Voluntarily sign and date an informed consent agreement approved by the Independent Ethics Committee (IEC).
    6. Be able to read, complete and understand the various rating instruments in English.
    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 a history of spontaneous priapism (ie, erection that lasts more than four hours)
    4. Has previously undergone surgery for Peyronie’s disease
    5. Fails to have an erection which, in the opinion of the investigator, is sufficient to accurately measure the subject’s penile deformity after administration of prostaglandin E1
    6. Has a calcified plaque as evident by appropriate radiographic evaluation, penile ultrasound that would prevent proper injection of study medication. Non-contiguous stippling of calcium is acceptable for inclusion provided the calcium deposit does not interfere with the injection of AA4500 into the plaque
    7. Has an isolated hourglass deformity of the penis
    8. 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
    9. Has previously received alternative medical therapies for Peyronie’s disease administered by the intralesional route (including, but not limited to, steroids, verapamil, and the naturally occurring low molecular weight protein, interferon-α2b) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study
    10. Has received alternative medical therapies for Peyronie’s disease administered by the oral (including, but not limited to, vitamin E [>500 U], potassium aminobenzoate [Potaba], tamoxifen, colchicine, pentoxifylline, over-the-counter erectile dysfunction medications, or steroidal anti-inflammatory drugs) or topical routes (including, but not limited to, verapamil applied as a cream) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study
    11. Has had extracorporeal shock wave therapy (ESWT) for the correction of Peyronie’s disease within the 6-month period before screening or plans to have ESWT at any time during the study
    12. Has used any mechanical type device for correction of Peyronie’s disease within the 2-week period before screening or plans to use any these devices (except for that prescribed by protocol) at any time during the study
    13. Has used a mechanical device to induce a passive erection within the 2-week period before screening or plans to use any of these devices (except for that prescribed by protocol) at any time during the study
    14. Has significant erectile dysfunction that has failed to respond to oral treatment with phosphodiesterase type 5 (PDE5) inhibitors
    15. Has a penile Duplex Doppler ultrasound evaluation at screening that shows compromised penile hemodynamics that in the opinion of the investigator is clinically significant
    16. Has uncontrolled hypertension, as determined by the investigator
    17. 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
    18. Has sickle cell trait or disease, multiple myeloma, Hodgkinson’s lymphoma, and/or a blood dycrasia that carries the risk for clotting or priapism
    19. Has an impairment of the hand(s) that would prevent safe use of the vacuum pump, as determined by the investigator
    20. Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits
    21. Has received an investigational drug or treatment within 30 days before the first dose of study drug
    22. Has a known allergy to collagenase or any other excipient of AA4500
    23. Has a known allergy to any concomitant medication required as per the protocol
    24. Has a coagulation disorder
    25. Is taking a medication for chronic anticoagulation (except for ≤ 150 mg aspirin daily)
    26. Has received any collagenase treatments within 30 days of the first dose of study drug
    27. Has, at any time, received AA4500 for the treatment of Peyronie’s disease
    E.5 End points
    E.5.1Primary end point(s)
    The percent improvement from baseline in penile curvature to be summarized with descriptive statistics at each evaluation window.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 42, 84, 126, 168 and 252.
    E.5.2Secondary end point(s)
    Secondary endpoint analyses are:
    - Change in Peyronie’s disease bother, psychological and physical symptoms of Peyronie’s disease, and penile pain
    - A responder analysis based on subject global assessment
    - Change in penile plaque consistency
    - Change in penile length
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Change in Peyronie’s disease bother, psychological and physical symptoms of Peyronie’s disease, and penile pain: Day 168 and 252.
    - A responder analysis based on subject global assessment: Day 168 and 252.
    - Change in penile plaque consistency: Day 1, 42, 84, 126, 168 and 252.
    - Change in penile length: Day 42, 84, 126, 168 and 252.
    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 Yes
    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 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
    The end of study is when the last subject completes the Day 252 (nominal week 36) follow-up visit.
    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 months4
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days1
    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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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.4.2.2In the whole clinical trial 30
    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)
    Patients who require further treatment will have options discussed with them by the study doctor.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-09
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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