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    Summary
    EudraCT Number:2007-005672-13
    Sponsor's Protocol Code Number:CR-DER-3-07 (07E0274PH)
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-11-13
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-005672-13
    A.3Full title of the trial
    DOUBLE-BLIND STUDY, RANDOMISED, ACTIVE AND PLACEBO CONTROLLED TO ASSESS THE CLINICAL EFFICACY, SKIN TOLERABILITY AND PHARMACOLOGICAL ACTIVITY OF UR-1505 OINTMENT AT THREE DIFFERENT STRENGHTS IN PATIENTS WITH MILD TO MODERATE PLAQUE-TYPE PSORIASIS
    A.4.1Sponsor's protocol code numberCR-DER-3-07 (07E0274PH)
    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 SponsorPALAU PHARMA SA
    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 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 nameUR-1505 0.5% OINTMENT
    D.3.2Product code UR 1505
    D.3.4Pharmaceutical form Ointment
    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) 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 Information not present in EudraCT
    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 nameUR-1505 2% OINTMENT
    D.3.2Product code UR 1505
    D.3.4Pharmaceutical form Ointment
    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) 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 Information not present in EudraCT
    D.IMP: 3
    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 nameUR-1505 4% OINTMENT
    D.3.2Product code UR 1505
    D.3.4Pharmaceutical form Ointment
    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) 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 Information not present in EudraCT
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name DAIVONEX
    D.2.1.1.2Name of the Marketing Authorisation holderLeo Pharmaceutical products
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Ointment
    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) 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 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 placeboOintment
    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 suffering from psoriasis with at least two eligible psoriatic plaques on equivalent topographic areas (arms, legs or trunk)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the clinical efficacy of UR-1505 (0.5%, 2% and 4%) applied once daily during 4 weeks with a vehicle without active ingredients and with an active treatment in adult patients with mild to moderate plaque-type psoriasis.
    E.2.2Secondary objectives of the trial
    - To assess the dose response relationship of three growing concentrations of UR-1505 ointment.
    - To assess safety and local tolerability of the experimental treatments.
    - To explore the global evaluation of each formulation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Sex: Male or female ·
    - Age: older than 18 and less than 75 years.
    - Phototype: I to IV according to the Fitzpatrick scale.
    - Patient with at least two eligible psoriatic plaques on equivalent topographic areas (arms, legs or trunk), each of a prefered size of 2% but in all cases smaller than 5% of body surface area.
    - For woman with child-bearing potential: use of a known, effective means of contraception (contraceptive pills, intra-uterine contraceptive device, tromp phallop ligation, implants, ring or condom) for at least 12 weeks prior to the study, during the study and one month after the end of the study.
    - Subject being psychologically able to understand information and to give his/her consent.
    - Subject having given freely and expressly his/her informed consent, cooperative and aware of the necessity and duration of the controls so that perfect adhesion to the protocol established by Group DERMSCAN can be expected.
    - Subject affiliated to a health social security system.
    E.4Principal exclusion criteria
    - Subject with a loss of personal liberty, by administrative or judicial decision.
    - Minor or major with a legal guardian.
    - Subject in a social or sanitary establishment.
    - Subject in an emergency situation.
    - Volunteer having been paid more than 4500€ to take part in biomedical researches over the previous 12 months.·
    - Pregnant or nursing woman or planning to be pregnant during the study.
    - Subject likely to be non observant to the study according to the investigator interpretation.
    - Patient registered as being in exclusion period in the French Health Minister File of Patients.
    - Subject suffering from a serious or progressive disease(s) that the investigator judges may interfere with the study.
    - Subject with a congenital or established immunity defect.
    - Subject with potentially malign or pre cancerous lesions.
    - Subject having a cutaneous pathology on the test zones except psoriasis.
    - Subject with clinical signs of infection on the test zones.
    - Subject with know allergy or hypersensitivity to a constituent of the products (in particular to salicylic compounds or any of substances used as a vehicle), as well as allergy or hypersensitivity reactions to calcipotriol ointment 0.005%.
    - Subject with any other skin disease that makes implementation of the protocol or interpretation of the study results difficult at investigator criteria.
    - Subject with know hypercalcemia.
    - History of erythrodermic, pustular psoriasis or severe psoriasis requiring hospitalisation.
    - Unstable psoriasis or psoriasis other than plaque-type.
    - Use of any topical anti-psoriatic therapy in selected plaques within two weeks of the study entry and during the study.
    - Use of any systemic anti-psoriatic therapy (including phototherapy) within 8 weeks prior to the study entry and during the study.
    - Subject receiving topical or systemic medical treatment:
    * Acetylsalicylic acid, anti-inflammatory, antihistamines drugs, or antibiotics in the week preceding the D0 and during the study,
    *immuno-suppressors and/or corticoids in the month preceding the D0 and during the study (stabilized treatment with inhaled corticosteroids for asthma and/ or nasal topical steroids for rhinitis will be allowed),
    *Topical tar derivatives, psoralenes, phototherapy or vitamin D derivatives in the 3 weeks prior to randomization.
    *Systemic retinoids (ex: Roaccutane®) in the six months preceding the D0 and during the study,
    *Any other treatment stabilized likely to interfere the results since less than one month before the D0.
    - Subject who was exposed to an UV sun lamp or excessive exposure to the sun within the month prior to the study and during the study.
    - Subject using dermopharmaceutical or cosmetics products (including keratolytics, salicylic acid, lactic acid, urea) other than emollients on the tested area over the period of the study.
    - Subject who has a recent history (within previous 12 months) of drug addiction or alcohol abuse.
    - Active tobacco smoker (more than 10 cigarettes/day).

    Exclusions :
    - Patient who presents a Serious Adverse effect, imputable or not to one of the treatments.
    - Patient who does not collaborate in his/her treatment, under the conditions provided by the information consent.
    - Patient whose clinical condition requires the application of products on the studied lesions other than the tested and compensation treatments allowed by the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end-point will be the differences in the change from baseline between UR-1505 at three concentrations (0.5%, 2% and 4%) and the active and negative controls in the localized PASI score (sum of values for scores in scaling, erythema and elevation) over four-week treatment period, as assessed by clinical examination by the dermatologist.
    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 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) 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) 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 Yes
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 Information not present in EudraCT
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    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
    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 months5
    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 state60
    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 Decision2007-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-29
    P. End of Trial
    P.End of Trial StatusOngoing
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