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    Summary
    EudraCT Number:2009-018024-15
    Sponsor's Protocol Code Number:CUV100
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-02-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-018024-15
    A.3Full title of the trial
    A Phase II, Randomised, Open Label Pilot Study to Evaluate the Efficacy and Safety of Two Dosage Regimens of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Mild to Moderate Acne Vulgaris.
    A.3.2Name or abbreviated title of the trial where available
    Phase II Acne Vulgaris Pilot Study
    A.4.1Sponsor's protocol code numberCUV100
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorClinuvel Pharmaceuticals Limited
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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.3.10.2Concentration typeequal
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 typeIMP is chemically synthesised uring amino acids from various sources. BSE/TSE certificates are available for these amino acids.
    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
    Acne vulgaris
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10000519
    E.1.2Term Acne vulgaris
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective:
    - To determine the effect of afamelanotide on the facial inflammatory acne-related lesions in patients with mild to moderate acne vulgaris.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    - To determine the effect of afamelanotide on the facial total and non-inflammatory acne-related lesions in patients with mild to moderate acne vulgaris;
    - To determine the effect of afamelanotide on the overall severity of acne in patients with mild to moderate acne vulgaris;
    - To determine the effect of afamelanotide on inflammatory biomarkers (cytokines) in patients with mild to moderate acne vulgaris;
    - To determine whether afamelanotide can improve the quality of life of patients with mild to moderate acne vulgaris;
    - To compare the effect of two dosage regimens of afamelanotide in patients with mild to moderate acne vulgaris;
    - To determine the effect of afamelanotide on skin melanin density in patients with mild to moderate acne vulgaris; and
    - To determine the safety and tolerability of afamelanotide in patients with mild to moderate acne vulgaris.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible to enter the study, patients must meet the following inclusion criteria:
    - Male subjects with a diagnosis of mild to moderate acne vulgaris, defined as an IGA score of 2-3;
    - Chronic course of acne vulgaris;
    - Acne-related lesions both on the face, chest and back;
    - Indication for treatment of acne vulgaris;
    - Aged 18-30 years (inclusive);
    - Fitzpatrick skin types I-III;
    - Agreeing to keep identical their shaving habits on the face during the entire study course; and
    - Providing written Informed Consent prior to the performance of any study-specific procedure.
    E.4Principal exclusion criteria
    To be eligible to enter the study, patients must not meet any of the following exclusion criteria:
    - Female subjects;
    - Diagnosis of severe acne vulgaris, defined as an IGA score of 4;
    - Indication for treatment of acne vulgaris with isotretinoin therapy;
    - Allergy to afamelanotide or the polymer contained in the implant or to lidocaine or other local anaesthetic to be used during the administration of the implant;
    - Use of topical acne medication such as retinoids, benzoyl peroxide or topical antibiotics within 2 weeks prior to the first dose;
    - Use of oral antibiotics for acne within 4 weeks prior to the first dose;
    - Use of topical corticosteroids on the face, chest and back or systemic corticosteroids within the past 4 weeks prior to the first dose. Use of inhaled, intra-articular or intra-lesional (other than for facial, chest and back acne lesions) steroids is acceptable;
    - Use of systemic retinoids within 6 months prior to the first dose;
    - Use of anti-androgenic agents such as finasteride within 4 weeks prior to the first dose;
    - Use of phototherapy devices for acne such as ClearLight(TM) or Zenozapper within 1 week prior to the first dose;
    - Use of tanning booths or lamps within 1 week prior to the first dose;
    - Use of the following types of products: astringents, toners, abradants, facials, peels containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide, sulfacetamide sodium or salicylic acid, non-mild cleansers or moisturizers that contain retinol, salicylic acid or α- or β-hydroxy acids for less than 2 weeks prior to the first dose;
    - Have had the following types of procedures: chemical or laser peel, microdermabrasion or artificial UV therapy, performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks prior to the first dose;
    - Personal history of melanoma, lentigo maligna or multiple (3 or more) dysplastic nevi;
    - Any malignant or premalignant skin lesions;
    - Active skin disease that may interfere with evaluation;
    - Diagnosed with HIV/AIDS or hepatitis;
    - 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;
    - Acute history of drug or alcohol abuse in the last 12 months;
    - Smoking;
    - Patients who are expected to suffer from specific forms of severe stress such as university or other examinations, recent divorce, death and life-threatening illness of a family member or partner;
    - Sexually active men with partners of childbearing potential not using barrier contraception during the trial and for a period of three months thereafter;
    - Have been shaving their back and/or chest 4 weeks prior to the screening visit;
    - Beard, moustache, sideburns (temporal zygomatic hair) or any other facial hair that may interfere with evaluation;
    - Other forms of acne such as acne rosacea, acne excoriée, chloracne, acne conglobata, acne fulminans, acne inversa or drug-induced acne;
    - History of significant post-inflammatory hyperpigmentation at the sites of acne lesions;
    - History of keloid formation for subjects undergoing biopsies;
    - Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit;
    - Unwilling or failing to adhere to washout periods for specified treatments or procedures; and
    - Patients assessed as not suitable for the study in the opinion of the Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of this study is:
    The percent change in the facial inflammatory acne-related lesions count from baseline to Day 56. This will be done on polled data from Groups A and B.

    H0: there will be no percent change in the facial inflammatory acne-related lesions count following afamelanotide treatment.
    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 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 Yes
    E.8.1.7.1Other trial design description
    Patients will be enrolled & randomised in equal numbers to one of two treatment groups. Refer D.3.5.
    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
    IMP
    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 Information not present in EudraCT
    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 the trial is defined by 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 months0
    E.8.9.1In the Member State concerned days84
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days84
    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.1.3Elderly (>=65 years) No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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 will resume normal care.
    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 Decision2010-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-08
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