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    Summary
    EudraCT Number:2010-022921-13
    Sponsor's Protocol Code Number:AUX-CC-802
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-30
    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 ConcernedSweden - MPA
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to assess the safety and effectiveness of AA4500 in the
    treatment of men with Peyronie's disease
    A.3.2Name or abbreviated title of the trial where available
    Open Label Study of AA4500 in Men With Peyronie's Disease
    A.4.1Sponsor's protocol code numberAUX-CC-802
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01243411
    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 Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAuxilium Uk Limited
    B.5.2Functional name of contact pointClinical Research International
    B.5.3 Address:
    B.5.3.1Street AddressOrchard Lea, Winkfield Lane
    B.5.3.2Town/ cityWindsor
    B.5.3.3Post codeBerks SL4 4RU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441344887665
    B.5.5Fax number+441344887666
    B.5.6E-mailnjones@auxilium.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 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 INN collagenase clostridium histolyticum
    D.3.9.2Current sponsor codeAA4500
    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 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
    E.1.1.1Medical condition in easily understood language
    Lump on penile shaft and curvature of the erect penis
    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 14.0
    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
    This study is a Phase 3, open-label study to evaluate the safety and efficacy of AA4500 0.58 mg in subjects with Peyronie’s disease.

    Primary endpoint analyses are the following:
    •Change from baseline in the Peyronie’s disease bother domain
    •Percent improvement from baseline in penile curvature
    E.2.2Secondary objectives of the trial
    Secondary endpoint analyses are:
    •Change from baseline in the severity of Peyronie’s disease physical and psychological symptoms
    •Change in the penile pain domain of the PDQ in subjects with penile pain score of at least 4 at baseline
    •A responder analysis based on subject global assessment
    •Change in the overall satisfaction domain of the IIEF
    •Change in penile plaque consistency
    •Change in penile length
    Safety will be assessed through the recording of adverse events, vital signs, change in the erectile function domain of the IIEF, and clinical laboratory testing.
    Immunogenicity will be assessed through the determination of anti-AUX-I and anti-AUX-II antibody levels and neutralizing potential of antibodies to AUX-I and AUX-II.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    No subject should be enrolled until all eligibility criteria have been satisfied. Subjects who receive placebo in a previous Auxilium-sponsored study may enroll in this study provided they continue to meet the eligibility requirements. To qualify for the study a subject must:
    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.
    E.4Principal exclusion criteria
    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 which in the opinion of the investigator is sufficient to accurately measure the subject’s penile deformity after administration of prostaglandin E1 or trimix
    5. Has a calcified plaque as evident by appropriate radiographic evaluation, penile x-ray or 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
    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 (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
    9. 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

    10. 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
    11. 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 at any time during the study
    12. 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 at any time during the study
    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 that in the opinion of the investigator is clinically significant
    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

    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint analyses are the following:
    • Change from baseline in the Peyronie’s disease bother domain
    • Percent improvement from baseline in penile curvature
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary time point for analyses will be Day 252 (nominal week 36)
    E.5.2Secondary end point(s)
    Secondary endpoint analyses are:
    • Change from baseline in the severity of Peyronie's disease physical and
    psychological symptoms
    • Change in the penile pain domain of the PDQ in subjects with penile
    pain score of at least 4 at baseline
    • A responder analysis based on subject global assessment
    • Change in the overall satisfaction domain of the IIEF
    • Change in penile plaque consistency
    • Change in penile length
    E.5.2.1Timepoint(s) of evaluation of this end point
    The primary time point for analyses will be Day 252 (nominal week 36).
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    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.8.3 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 concerned3
    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 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
    New Zealand
    United States
    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 years0
    E.8.9.1In the Member State concerned months16
    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.1.1.1In 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: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 300
    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)
    Subjects should receive all the treatment that they require as part of the study protocol. They also have the option of proceeding with surgery at the end of the study if further treatment is required. Currently surgery is the only treatment currently available.
    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 Decision2011-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-10
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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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