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    Summary
    EudraCT Number:2004-000940-26
    Sponsor's Protocol Code Number:CASM981C2314
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-06-29
    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 ConcernedFinland - Fimea
    A.2EudraCT number2004-000940-26
    A.3Full title of the trial
    A 22-week randomized, multicenter, parallel-group, double-blind study to compare a pimecrolimus 1 % (Elidel) twice daily (b.i.d.) maintenance dosing regimen to a once daily (o.d.) maintenance dosing regimen in the management of atopic dermatitis in pediatric subjects.
    A.4.1Sponsor's protocol code numberCASM981C2314
    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 SponsorNovartis Pharma
    B.1.3.4CountrySwitzerland
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Elidel
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Finland Oy
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 namePimecrolimus 1 %
    D.3.2Product code ASM981
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPimecrolimus
    D.3.9.2Current sponsor codeASM981
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 No
    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 placeboCream
    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
    Atopic dermatitis
    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 primary objective for this study is to demonstrate the relative efficacy of pimecrolimus cream 1% applied twice daily (b.i.d.) versus once daily (o.d.) in preventing the progression to disease “relapse” (defined as exacerbation of disease to the level where a topical corticosteroid and/or alternative or additional therapy is required [confirmed by IGA score of 3 or more and a pruritus score of 2 or 3).
    E.2.2Secondary objectives of the trial
    The safety and tolerability of pimecrolimus cream 1% when applied either b.i.d. or o.d. Disease-free time for subjects who achieve “remission” of AD during the Run-in phase to the time of “recurrence” of AD during the Maintenance period (from randomization to 1st day of double-blind study drug).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Inclusion criteria-Screening/Run-in Period
    *age >=2 years through age <=17 years of age
    * IGA score of 2, 3, or 4 (mild, moderate, or severe AD) affecting ≥5% TBSA (estimated using the subject’s palm of the hand as approximately 1% TBSA)
    * outpatients
    * subject (or primary caregiver) has been informed of the study procedures and requirements and has signed the approved informed consent form (and patient assent form if applicable)

    Inclusion criteria - Double-blind Maintenance treatment period
    *Achieve complete remission of active disease (no signs or symptoms of AD) without incidence of “relapse” by the end of 6-week Run-In period (may be earlier), or who achieve “disease improvement” (decrease in IGA score by 1 full point confirmed by the investigator) without incidence of relapse at the end of the 6-week Run-In period.
    E.4Principal exclusion criteria
    Exclusion criteria-Screening/Run in Period
    *subjects who applied topical therapy (e.g. tar, topical corticosteroids, pimecrolimus (Elidel®) or tacrolimus (Protopic®) within 2 weeks prior to Screening
    *subjects who received phototherapy (e.g. UVB, PUVA, Narrow Band) within 4 weeks of Screening
    *subjects who received any systemic immunosuppressant (e.g. Neoral®, Cyclosporine®, Prograff®, methotrexate, etc.) within 4 weeks of Screening
    *subjects who received systemic steroids (e.g. oral, intravenous, intra-articular, rectal) for any reason within 4 weeks of Screening
    *females who are pregnant or breast-feeding, or planning to become pregnant during the study
    *females who are menstruating and capable of becoming pregnant and not practicing a medically approved method of contraception (required during study and up to 4 weeks post-treatment). A “medically approved” method of contraception may include abstinence at the discretion of the investigator. (A negative urine pregnancy test is required for all females of childbearing potential at Screening)
    *subjects who are immunocompromised (e.g. lymphoma, AIDS, Wiskott-Aldrich syndrome) or have a history of malignancy (includes basal cell carcinoma, squamous cell carcinoma, melanoma)
    *subjects with open skin infections (bacterial, viral or fungal) if at the application site. Subjects will HSV (common cold sores) are allowed to participate in the study (if not at the application site).
    *subjects who have head lice or scabies
    *subjects who present with clinical conditions other than AD that may interfere with the evaluation (e.g., generalized erythroderma, acne, Netherton’s Syndrome, psoriasis)
    *subjects that require systemic therapy for the treatment of atopic dermatitis
    *subjects with poor or no clinical response to tacrolimus ointment (Protopic®) or pimecrolimus cream 1%
    *subjects who used any experimental or investigational drug or therapy within 6 weeks prior to Screening
    *subjects who intend to use experimental or investigational drug therapy during the course of this study
    *subjects with known hypersensitivity to pimecrolimus 1% or related drugs (see Investigator’s Brochure)
    *subjects who are non-compliant with general medical treatment, or are known to miss appointments, or don’t intend to comply with the protocol for the duration of the study drug abuse, mental dysfunction, or other factors limiting the subject’s ability to cooperate fully with study-related procedures
    *subjects known to be unreliable or may be unable to complete the study
    *Any condition or prior/present treatment that would render the subject ineligible for the study

    Exclusion criteria - Double-blind Maintenance treatment period
    *subjects who experienced a “relapse” during the Run-In period
    *subjects who applied topical corticosteroids or any alternative or additional therapy for the treatment of AD during the Run-In period
    *subjects with active skin infections (bacterial, viral or fungal) except common cold sores (HSV) at the application site
    *subjects who failed to record study medication use (and non use) and dosing regimen during the Run-In period
    *subjects who failed to apply open label study drug twice daily until “disease remission” or end of the 6 week Run-In period (whichever occurred first)
    *subjects who failed to record concomitant medications during the Run-In period
    failure to return open-label study drug (used, partially used, and unused tubes) at the time double-blind study drug is dispensed. In order to avoid medication error, all open label study drug must be returned to the site before starting the Maintenance period (a window of 48 hours to return open-label medication is allowed)
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective for this study is to demonstrate the relative efficacy of pimecrolimus cream 1% applied twice daily (b.i.d.) versus once daily (o.d.) in preventing the progression to disease “relapse” (defined as exacerbation of disease to the level where a topical corticosteroid and/or alternative or additional therapy is required [confirmed by IGA score of 3 or more and a pruritus score of 2 or 3).
    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 No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 400
    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 Decision2004-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
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