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    Summary
    EudraCT Number:2007-006738-33
    Sponsor's Protocol Code Number:CL-1205
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-08
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2007-006738-33
    A.3Full title of the trial
    bLAC - A phase II double-blind, placebo controlled, clinical proof of concept trial of the efficacy of 8 weeks treatment of cutaneous warts with bLAC in immune suppressed, kidney transplanted patients
    A.4.1Sponsor's protocol code numberCL-1205
    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 SponsorNatImmune A/S
    B.1.3.4CountryDenmark
    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 nameBovine α-lactalbumin complex with oleic acid(bLAC)
    D.3.2Product code bLAC
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous 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) Yes
    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 typeActive substance is bovine alpha-lactalbumin in complex with oleic acid
    D.IMP: 2
    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 nameBovine α-lactalbumin complex with oleic acid(bLAC)
    D.3.2Product code bLAC
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous 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) Yes
    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 typeActive substance is bovine alpha-lactalbumin in complex with oleic acid
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGel
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cutaneous wart lesions on hands and/or feet at immune suppressed, kidney transplanted patients.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10010115
    E.1.2Term Common warts
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The clinical proof of concept of bLAC is to demonstrate a reduction in the area of the wart lesions located on fingers and/or palms and/or toes and/or soles of the feet, (measured by an objective method by drawings of the individual lesions) at two dose levels of bLAC, compared with placebo

    The lowest dose of bLAC that will be efficacious in treatment of warts will be recommended for further studies.
    E.2.2Secondary objectives of the trial
    The secondary efficacy objectives are to investigate the efficacy of bLAC in comparison with placebo
    • to clear index warts
    • on time to clear index warts
    • on changes in area of total index lesion size over time
    • to prevent recurrence of previously cleared index warts
    • to prevent new wart lesions to occur
    • to assess overall changes in index wart lesions
    • to assess the overall status of other wart lesions on hands and feet (index wart lesions excluded) and impact of treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with cutaneous warts located on fingers and/or palms and/or toes
    and/or soles of the feet.
    2. Index Wart lesions include: common warts (verruca vulgaris) and mosaic
    warts. Index warts lesions must be diagnosed by an experienced dermatologist
    on clinical basis.
    3. Patients with a solitary wart lesion with a diameter of at least 1 cm2, or patients
    with 2 or more wart lesions, the minimum area of each of the selected index
    wart lesions is 0.5 cm². (A maximum of eight lesions is selected for treatment
    and the maximum of total index lesion area ≤ 9 cm²).
    4. Index wart lesions should have been present for more than 6 months.
    5. Men or women, aged 18 or above.
    6. All patients should have a history of a kidney transplantation and immune
    suppressive therapy after the transplant.
    7. Concomitant immune suppressive therapy should have been stable for 6
    monthsprior to randomisation, defined as no changes in number of drugs used,
    but a change in doses for the individual immune suppressive drugs of ± 50 % is
    allowed in the 6 months prior to randomisation
    8. Agreement from the patient to allow photographs of the selected warts to be
    taken and used as part of the trial data documentation (2 centres).
    9. Women of childbearing potential must have a negative pregnancy test at
    screening and must use adequate contraception (pill, contraceptive implant,
    intrauterine device) during the trial.
    10. Ability to comply with the requirements of the trial.
    11. Written informed consent.
    E.4Principal exclusion criteria
    1. Verruca plana lesions.
    2. Patients suspected of allergy to milk verified by serum analysis of IgG towards
    cow milk.
    3. Breastfeeding patients.
    4. Any local medications for any purpose other than wart treatment in the target
    area during 4 weeks prior to randomisation and during the treatment period
    (weeks 0-8).
    5. Concomitant treatment with other wart therapies two weeks prior to
    randomisation in the present trial and during the clinical trial period.
    6. Intolerance towards bovine α-lactalbumin, oleic acid, or any excipient in the bLAC
    formulation.
    7. Known HIV infection or any current uncontrolled infection.
    8. Any chronic or acute skin condition susceptible of interfering with the evaluation
    of the drug effect in this trial.
    9. Participation in any investigational trial or use of any investigational drug within
    30 days prior to inclusion in this trial.
    10. Any health problems, which according to the Investigator’s clinical judgment will
    make the patient unsuitable for inclusion in the trial.
    E.5 End points
    E.5.1Primary end point(s)
    Percent change from baseline to end-of 8 weeks treatment in the pre-selected wart lesion size, determined as area of lesion. The area of each index lesion will be calculated based on drawing and area will be determined by scanning of the drawing.

    The primary endpoint will be summarized by mean percent change, classified by treatment and visit for each centre.
    The statistical model for the rate of reduction at week 1, 4 and 8 will be a mixed model ANOVA. The null hypothesis to be tested is that there is no difference in treatment effects at visit four (week 8).
    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 Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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
    dose finding study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 concerned5
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA5
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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 Decision2008-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-04-01
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