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    The EU Clinical Trials Register currently displays   38002   clinical trials with a EudraCT protocol, of which   6235   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-003162-42
    Sponsor's Protocol Code Number:M/37779/21
    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:2005-08-26
    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 number2005-003162-42
    A.3Full title of the trial
    A double-blind, randomized, parallel, multicenter, vehicle-controlled, left/right paired comparison to study the efficacy, safety and tolerability of 1% LAS 37779 cream administered once and twice daily topically during 4 weeks in patients with chronic plaque psoriasis.
    A.4.1Sponsor's protocol code numberM/37779/21
    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 SponsorAlmirall Prodesfarma S.A.
    B.1.3.4CountrySpain
    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.2.5The 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 nameLAS 37779
    D.3.2Product code LAS 37779
    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.3.9.2Current sponsor codeLAS 37779
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    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 Yes
    D.3.11.13.1Other medicinal product typephosphodiesterase (PDE) 4 inhibitor
    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
    patients with mild to moderate chronic plaque psoriasis
    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
    To assess the efficacy of 1 % LAS 37779 cream once and twice daily during 4 weeks compared to vehicle, in patients with chronic plaque psoriasis.
    E.2.2Secondary objectives of the trial
    To determine the onset of action, the duration of effect and whether rebound is induced in an 8-week single-blind evaluator-blinded follow-up period after stopping the treatment.
    To assess the safety and tolerability of 1 % LAS 37779 cream compared to vehicle.
    To investigate the systemic drug and metabolite levels of 1 % LAS 37779 cream after single and repeated cutaneous applications in this population of patients.
    As an additional and explorative objective, an assessment will be made whether or not clinical improvement goes along with changes in lesion histomorphology, immunochemistry and gene expression of the psoriatic phenotype.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Males and non-pregnant, non-lactating females aged 18 to 65 years, both inclusive. Women of childbearing potential are allowed to enter the trial ONLY if they use medically approved (i.e., mechanical or pharmacological ) contraceptive measures. A female is considered to be of childbearing potential unless she is hysterectomised or at least one year post-menopausal or has undergone tubal ligation. All women of childbearing potential must have a negative pregnancy test at screening visit.
    2. Patients who are eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained to them.
    3. Patients with a confirmed clinical diagnosis of stable plaque (or vulgaris) psoriasis comprising between 3 % and 30 % of body surface area, provided there are two comparable symmetrical bilateral areas between 20 and 200 cm2.
    4. Patients with a comparable baseline Total Sign Score (sum score for erythema, induration and scaling) of at least 6 of 12 for each of the treated areas.
    5. Patients in good general condition as confirmed by medical history, physical examination, vital signs measurements, ECG recording and laboratory testing.
    6. Patients not willing to use antipsoriatic therapies for the duration of the trial, except for emollients used outside the treated areas.
    E.4Principal exclusion criteria
    1. Patients with pustular, erythrodermic, exfoliative, inverse or guttate psoriasis and/or psoriatic arthritis.
    2. Patients with spontaneously/rapidly improving or rapidly deteriorating plaque psoriasis.
    3. Patients who have received phototherapy, photochemical (PUVA) therapy or systemic antipsoriatic therapy, such as, but not limited to, corticosteroids, retinoids, vitamin D3 analogues, or immunosuppressive agents (methotrexate, cyclosporine) within 4 weeks before the first trial treatment at Visit 1.
    4. Patients who have received any topical antipsoriatic agents such as, but not limited to, corticosteroids, vitamin D3 analogues, salicylates, anthralin, and emollients, within the 2 weeks before the first trial treatment at Visit 1. Use of emollients outside the target lesions will be permitted, provided that the concentration, frequency and quantity throughout the trial are kept similar to those used prior to trial entry.
    5. Patients who have received any research medication within the 8 weeks before trial entry at the Screening Visit.
    6. Patients under treatment with drugs that might worsen psoriasis, such as lithium or beta-adrenergic antagonists.
    7. Patients who have received prolonged sun exposure of the target lesions within 4 weeks before the first trial treatment at Visit 1 or who intend to have prolonged sun exposure of the target lesions during the trial, which is likely to modify the subject’s disease.
    8. Patients with a history of opportunistic infections, including skin infections, that might interfere with the trial objectives within 6 months prior to the Screening Visit.
    9. Patients who have known clinically significant abnormal hepatic and/or renal function.
    10. Patients known to be hypersensitive to the trial medication or any of its components.
    11. Patients with disease states or physical conditions that would impair evaluation of the test therapy. Such disease states include, but are not limited to, AIDS or infection with HIV, and autoimmune diseases.
    12. Patients with any serious or uncontrolled physical or mental dysfunction at the discretion of the investigator which could place the patient at higher risk derived from his/her participation into the trial, could confound the results of it or is likely to prevent the patient from complying with the requirements of the trial or completing the treatment period.
    13. Patients with a history of drug abuse or continuous alcohol consumption that may prevent compliance with trial procedures.
    14. Patients unlikely to be co-operative, to take their medication, to complete their Diary Card or to attend the clinic at the required time in the morning.
    E.5 End points
    E.5.1Primary end point(s)
    Main variable:
    Change from baseline in the Total Sign Score of each treated area at the end of treatment (Day 28). Total Sign Score is defined as the sum of individual scores for erythema, induration and scaling [score 0 (absent) to 4 (very severe) for each sign].

    Secondary variables:
    Efficacy:
    - Change from baseline in the Total Sign Score of each treated area at Days 7, 14, and 21 of treatment and at Days 14, 28, 42 and 56 after stopping treatment.
    - Change from baseline in the score for each individual sign (erythema, induration and scaling) of each treated area at Days 7, 14, 21 and 28 of treatment and at Days 14, 28, 42 and 56 after stopping treatment.
    - Percentage of treated areas with an Investigator's Global Assessment of Treatment Response rated as 50 %, 75 %, 90 % and 100 % clear at Days 7, 14, 21 and 28 of treatment and at Days 14, 28, 42 and 56 after stopping treatment.
    - Percentage of treated areas reaching a 50 % or 75% decrease from baseline in Total Sign Score at Days 7, 14, 21 and 28 of treatment and at Days 14, 28, 42 and 56 after stopping treatment.
    - Time to reach a 50 % or 75 % reduction from baseline in Total Sign Score (onset of action).
    - Duration of time with a 50 % or 75 % reduction from baseline in Total Sign Score after stopping treatment (duration of action).
    - Percentage of treated areas with a loss of half of Total Sign Score improvement achieved at Day 28 of treatment and at Days 14, 28, 42 and 56 after stopping treatment.
    - Percentage of treated areas reaching 125 % of baseline Total Sign Score at Days 14, 28, 42 and 56 after stopping treatment (rebound effect).

    Histomorphology, immunochemistry and gene expression:
    Changes in these 3 above mentioned items of punch biopsies of treated lesional areas taken at baseline and Day 28 of treatment.
    - Histological phenotype, epidermal thickness, quality and quantity of the inflammatory infiltrate, architecture of the papillary blood vessels, papillomatosis, perifocal and epidermal reactions.
    - Qualitative description of the inflammatory cell infiltrate, reactions with different monoclonal antibodies directed to antigens CD1a, CD3, CD4, CD8, CD25, CD31, CD54, HLA-DR, filaggrin, involucrin, keratin-16 and Ki-67.
    - RNA analysis: elafin, psoriasin, K16, ICAM-1, IFN-g, IL-2, IL-7R, IL-7, IL-8, IL-12(p40), IL-23(p19), IL-12(p35), IL-15, IL-17, IL-19, IL-20, TNF-a, STAT-1, STAT-3, TRIM22, IP-10, IRF-1, RANTES, CTLA-4, IL
    For this purpose punch biopsies will be obtained from a maximum of twenty patients.

    Plasma levels of LAS 37779 and its metabolites:
    Plasma levels and pharmacokinetic parameters will be determined after single (Day 1 of treatment) and repeated application (Day 28 of treatment). At days 7, 14 and 21 of treatment, plasma drug levels will be determined before IMP morning application.
    A maximum of thirty-two patients will be included for this purpose.

    Safety and tolerability:
    Adverse events recorded during the treatment and follow-up phases, including laboratory evaluations, vital signs and 12-lead ECG and Global Assessment of Tolerability.

    Other variables:
    Number of withdrawals and reasons for withdrawal.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    intraindividual comparison
    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 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 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 years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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) 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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-08-26. Yes
    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 state52
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    F.4.2.2In the whole clinical trial 52
    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)
    not applicable
    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 Decision2005-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-09-29
    P. End of Trial
    P.End of Trial StatusCompleted
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