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    Summary
    EudraCT Number:2012-000253-30
    Sponsor's Protocol Code Number:LP0075-34
    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:2012-09-25
    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 number2012-000253-30
    A.3Full title of the trial
    An exploratory study evaluating the efficacy of cromoglicate cream compared to cream vehicle in the treatment of itch in psoriasis
    Eine explorative Studie, die die Wirksamkeit einer Cromoglicat-Creme im Vergleich zum Trägerstoff bei der Behandlung von Juckreiz bei Psoriasis untersucht
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating the efficacy of cromoglicate cream compared to cream vehicle in the treatment of itch in psoriasis
    Eine Studie, die die Wirksamkeit einer Cromoglicat-Creme im Vergleich zum Trägerstoff bei der Behandlung von Juckreiz bei Psoriasis untersucht
    A.4.1Sponsor's protocol code numberLP0075-34
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLEO Pharma 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 supportLEO Pharma A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLEO PHarma GmbH
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Str. 233
    B.5.3.2Town/ cityNeu Isenburg
    B.5.3.3Post code63263
    B.5.3.4CountryGermany
    B.5.4Telephone number00496102201106
    B.5.5Fax number00496102201100
    B.5.6E-maildagmar.joos-spreng@leo-pharma.com
    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 namecromoglicate cream
    D.3.2Product code LP0075
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    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 INNCROMOGLICATE SODIUM
    D.3.9.1CAS number 15826-37-6
    D.3.9.2Current sponsor codeLP0075
    D.3.9.4EV Substance CodeSUB01492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    itchy psoriasis
    Juckreiz bei Psoriasis Vulgaris
    E.1.1.1Medical condition in easily understood language
    itchy psoriasis
    Juckreiz bei Psoriasis Vulgaris
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10050576
    E.1.2Term Psoriasis vulgaris
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the clinical efficacy on itch of treatment with cromoglicate cream in subjects with itchy psoriasis
    Untersuchung der klinischen Wirksamkeit einer Behandlung mit Cromoglicat-Creme bei Patienten mit juckender Psoriasis
    E.2.2Secondary objectives of the trial
    To investigate the safety of treatment with cromoglicate cream in subjects with itchy psoriasis

    To investigate pharmacodynamic parameters related to itch and the mode of action of cromoglicate
    Untersuchung der Sicherheit einer Behandlung mit Cromoglicat-Creme bei Patienten mit juckender Psoriasis

    Untersuchung der pharmakodynamischen Parameter hinsichtlich Juckreiz und der Wirkweise von Cromoglicat.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent has been obtained
    2. Age 18 years or above
    3. Either sex
    4. Any race or ethnicity
    5. Attending hospital outpatient clinic or the private practice of a dermatologist
    6. Clinical diagnosis of stable plaque psoriasis of at least 6 months with a symmetric distribution
    7. Two treatment areas with a symmetrical distribution each corresponding to 2-3% BSA and each including at least one itchy psoriasis plaque
    8. Itchy psoriasis on both intended treatment areas of at least 40mm on the Visual Analogue Scale (VAS) with a maximum difference of 10mm on the visual ana-logue scale between each of the two treatment areas
    9. Disease severity graded mild, moderate or severe according to the Physician’s global assessment (PGA) of disease severity on psoriasis plaques on each of the two treatment areas. The disease severity must be the same for both treatment areas
    1. Unterschriebene Einverständniserklärung wurde eingeholt
    2. Alter 18 Jahre oder älter
    3. Beiderlei Geschlechts
    4. Jede Rasse oder ethnische Zugehörigkeit
    5. Behandlung in einer Krankenhausambulanz oder privaten Praxis eines Dermatologen
    6. Klinische Diagnose einer stabilen Plaque-Psoriasis über mindestens 6 Monate mit einer systemischen Verteilung
    7. Zwei Behandlungsareale mit einer symmetrischen Verteilung, die beide mit 2-3% BSA korrespondieren und beide mindestens eine juckende Psoriasis-Plaque enthalten.
    8. Juckende Psoriasis an beiden vorgesehenen Behandlungsarealen mit mindestens 40mm auf der Visuellen Analog Skala (VAS) und einer maximalen Differenz von 10mm auf der VAS zwischen den beiden Behandlungsarealen.
    9. Schweregrad der Erkrankung ist eingestuft als mild, mäßig oder schwer entsprechend der globalen Einschätzung des Arztes (Physicians`s Global As-sessment / PGA) bezüglich des Schweregrads der Psoriasis-Plaques an jedem der beiden Behand-lungsarealen. Der Schweregrad der Erkrankung muss an beiden Behandlungsarealen gleich sein.
    E.4Principal exclusion criteria
    1. Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
    • etanercept – within 4 weeks prior to randomisa- tion
    • adalimumab, infliximab – within 8 weeks prior to randomisation
    • ustekinumab – within 16 weeks prior to randomisation
    • other products – 4 weeks/5 half-lives (whichev- er is longer)
    2. Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticoster-oids, retinoids, methotrexate, ciclosporin, fumaric acid derivatives, and other immunosuppressants) within 4 weeks prior to randomization
    3. Any topical treatment of the treatment areas (except for emollients) within 2 weeks prior to randomisation.
    4. Treatment with therapies, whether marketed or not, with a possible effect on itch within the following time periods prior to randomisation:
    • antihistamins – within 1 week prior to randomi- sation
    • gabapentin – within 4 weeks prior to randomi- sation
    5. Subjects who have received treatment with any non-marketed drug substance (i.e. a drug which has not yet been made available for clinical use following regis-tration) within the 4-week period prior to randomisa-tion or longer, if the class of substance required a longer treatment free period as defined in exclusion criterion 1 for biological treatments
    6. PUVA or Grenz ray therapy within 4 weeks prior to randomisation.
    7. UVB therapy within 2 weeks prior to randomisation
    8. Planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, ACE inhibitors, anti-malaria drugs, lithium) within 2 weeks prior to randomisation
    9. Subjects with current participation in any other interventional clinical trial
    10. Subjects with any of the following conditions present on the treatment areas: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infec-tions, parasitic infections, skin manifestations in rela-tion to syphilis or tuberculosis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ic-thyosis, ulcers and wounds
    11. Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis
    12. Subjects with a history of serious allergy, allergic skin rash or sensitivity to any component of the investiga-tional products or formulations being tested
    13. Known or suspected severe renal insufficiency or severe hepatic disorders
    14. Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis
    15. Planned exposure to the sun during the study that may affect psoriasis vulgaris (i.e., normal lifestyle outdoor activities are permitted but deliberate exposure to sunlight or artificial ultraviolet light should be avoid-ed)
    16. Subjects previously randomised into this trial
    17. Subjects known or, in the opinion of the investigator, being unlikely to comply with the Clinical Study Pro-tocol (e.g., due to alcoholism, drug dependency or psychotic state)
    18. Females who are pregnant, females of child-bearing potential and wishing to become pregnant during the trial or are breast feeding.
    19. Females of child-bearing potential with positive pregnancy test at visit 1
    20. Subjects (or their partner) not using an adequate method of contraception (according to national re-quirements, as applicable)
    21. Commitment to an institution in terms of § 40 Abs. 1 S. 3 Nr. 4 AMG
    1. Systemische Behandlung mit biologischen Thera-pien, ob vermarkted oder nicht, die einen möglichen Effekt auf Psoriasis Vulgaris haben, innerhalb der folgenden Zeitfenster vor Randomisierung:
    • Etanercept – innerhalb von 4 Wochen vor Ran-domisierung
    • Alalimumab, Infliximab – innerhalb von 8 Wo-chen vor Randomisierung
    • Ustekinumab – innerhalb von 16 Wochen vor Randomisierung
    • Andere Produkte - 4 Wochen / 5 Halbwertszei-ten (je nachdem was länger ist)
    2. Systemische Behandlung mit allen anderen Therapien, die einen möglichen Einfluss auf Pso-riasis Vulgaris haben (z.B. Kortikosteroide, Retinoi-de, Methotrexat, Ciclosporin, Derivate der Fumar-säure und andere Immunsuppressiva) innerhalb von 4 Wochen vor Randomisierung
    3. Jede topische Behandlung der Behandlungsareale (außer mit erweichenden Mitteln) innerhalb von 2 Wochen vor Randomisierung
    4. Behandlung mit Therapien, ob vermarktet oder nicht, mit einem möglichen Effekt auf Juckreiz in-nerhalb der folgenden Zeitfenster vor Randomisie-rung:
    • Antihistaminika – innerhalb von einer Woche vor Randomisierung
    • Gabapentin – innerhalb von 4 Wochen vor Ran-domisierung
    5. Patienten, die Behandlungen mit irgendwelchen nicht vermarkteten Arzneimitteln (z.B. ein Arzneimittel, das noch nicht durch Zulassung für den klinischen Einsatz zur Verfügung steht) innerhalb von 4 Wochen vor Randomisierung erhalten oder länger, wenn die Substanzklasse eine längere behand-lungsfreie Zeit erfordert wie in dem Ausschlusskri-terium 1 für biologische Therapien beschrieben.
    6. PUVA- oder Grenz-Ray-Therapie innerhalb von 4 Wochen vor Randomisierung
    7. UVB-Therapie innerhalb von 2 Wochen vor Rando-misierung
    8. Geplanter Beginn oder Änderungen von Begleit-medikation, die einen Effekt auf Psoriasis Vulgaris haben könnten (z.B. Betablocker, ACE-Hemmer, Anti-Malaria-Mittel, Lithium) innerhalb von 2 Wochen vor Randomisierung
    9. Patienten, die gegenwärtig an irgend einer anderen klinischen Studie teilnehmen
    10. Patienten mit einer der folgenden Zustände an den Behandlungsarealen: virale (z.B. Herpes oder Vari-zella) Läsionen der Haut, Pilz- und bakterielle Hau-tinfektion, parasitäre Infektion, Hautmanifestatio-nen hinsichtlich Syphilis oder Tuberkulose, Akne Vulgaris, atrophische Haut, Striae Atrophicae, brü-chige Hautvenen, Ichtyosen, Geschwüre und Wun-den
    11. Andere entzündliche Hauterkrankungen (z.B. seborrhoeische Dermatitis oder Kontaktdermatiis) am Behandlungsareal, die die Beurteilung der Pso-riasis vereiteln könnten
    12. Patienten mit einer Historie von schweren Allergien, allergischem Hautausschlag oder Empfindlichkeit auf irgendeinen Bestandteil der Studienmedikation oder Zubereitungen
    13. Bekannte oder vermutete schwere Niereninsuffizi-enz oder schwere Lebererkrankung
    14. Aktuelle Diagnose einer erythrodermischen, exfoliativen, guttate oder pustulären Psoriasis
    15. Geplante Sonnenexposition während der Studie, die Psoriasis Vulgaris beeinflussen könnte (z.B. Aktivitäten im Freien, die dem normalen Lebensstil entsprechen, sind erlaubt aber absichtliches Aus-setzten dem Sonnenlicht oder künstliche UV-Bestrahlung soll vermieden werden)
    16. Personen, die bereits schon früher einmal in dieser Studie randomisiert wurden
    17. Personen, die nach Einschätzung des Prüfarztes den Anforderungen des Studienprotokolls voraussichtlich nicht nachkommen werden (z.B. Alkoholismus, Drogenabhängigkeit oder psychischer Zustand)
    18. Frauen, die schwanger sind oder im gebärfähigen Alter und wünschen während der Studie schwanger zu werden oder die stillen.
    19. Frauen im gebärfähigen Alter mit einem positiven Schwangerschaftstest zu Visit 1.
    20. Personen (oder deren Partner) die keine adäquate Verhütungsmethode anwenden (definiert als Pearl Index < 1)
    21. Unterbringung in einer Einrichtung gemäß § 40 Abs. 1 S. 3 Nr. 4 AMG
    E.5 End points
    E.5.1Primary end point(s)
    Change in Visual analog scale of itch from baseline to end of treatment
    Änderungen der visuellen Analog-Skala vom Ausgangswert bis Behandlungsende
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 14
    Tag 14
    E.5.2Secondary end point(s)
    Change in 4-point itch scale from baseline to end of treatment
    Change in 7-point itch scale from baseline to end of treatment
    Änderungen der 4-Punkte Juckreizskala vom Ausgangswert bis Behandlungsende
    Änderungen der 7-Punkte Juckreizskala vom Ausgangswert bis Behandlungsende
    E.5.2.1Timepoint(s) of evaluation of this end point
    day 14
    Tag 14
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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
    rechts-/links-Vergleich; jeder Patient erhält verblindet aktive Substanz und Placebo
    left/right comparison study, each subject will use blinded actice and placebo
    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.8.2.4Number of treatment arms in the trial1
    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 No
    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
    LVLS
    letzer Besuch des letzten Patienten
    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 months6
    E.8.9.1In the Member State concerned days0
    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.1.2.1Number of subjects for this age range: 28
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 2
    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 state30
    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)
    expected normal treatment of that condition
    Die übliche Behandlung dieser Erkrankung.
    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 Decision2012-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-11
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