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    Summary
    EudraCT Number:2013-000410-38
    Sponsor's Protocol Code Number:LP0066-1019
    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:2013-08-01
    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 number2013-000410-38
    A.3Full title of the trial
    Topical Aprepitant in Prurigo Patients (iTAPP)

    An exploratory phase IIa trial with topically applied aprepitant in patients with prurigo
    Topisches Aprepitant bei Patienten mit Prurigo (iTAPP)

    Eine explorative Phase IIa Studie mit lokal angewendeten
    Aprepitant Gel bei Patienten mit Prurigo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial for evaluation of efficacy and safety of an aprepitant gel in itching disease (Prurigo).
    Eine klinische Studie zur Überprüfung der Wirksamkeit und Sicherheit von Aprepitant Gel bei einer Juckreizerkrankung (Prurigo)
    A.3.2Name or abbreviated title of the trial where available
    Topical Aprepitant in Prurigo Patients (iTAPP)
    Topisches Aprepitant bei Patienten mit Prurigo (iTAPP)
    A.4.1Sponsor's protocol code numberLP0066-1019
    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.1.3.4CountryGermany
    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 supportCharite -Department of Dermatology
    B.4.2CountryGermany
    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 organisationCharité-Department of Dermatology
    B.5.2Functional name of contact pointPrincipal investigator, Prof. Metz
    B.5.3 Address:
    B.5.3.1Street AddressCharitéplatz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10117
    B.5.3.4CountryGermany
    B.5.4Telephone number004930450518159
    B.5.5Fax number004930450518919
    B.5.6E-mailmartin.metz@charite.de
    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 nameaprepitant gel
    D.3.4Pharmaceutical form Gel
    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 INNAprepitant
    D.3.9.1CAS number 170729-80-3
    D.3.9.2Current sponsor codeLP0066
    D.3.9.3Other descriptive nameAPREPITANT
    D.3.9.4EV Substance CodeSUB20017
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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
    Prurigo can present either with hyperkeratotic nodules as prurigo nodularis or without nodules as Prurigo simplex. The disease is characterised by intensely pruritic, lichenified, or excoriated papules and nodules. A hallmark symptom is chronic pruritus, often associated with a high impact on quality of life.
    Prurigo kann sich entweder mit hyperkeratotischen Knoten als Prurigo nodularis oder ohne Knoten als Prurigo simplex manifestieren. Die Erkrankung ist charakterisiert durch intensiven Juckreiz, lichenifizierte oder exkoriierte Papeln und Nodi. Ein Hauptsymptom ist chronischer Juckreiz, häufig assoziiert mit einer Beeinflussung der Lebensqualität.
    E.1.1.1Medical condition in easily understood language
    Prurigo is a skin disease associated with pruritus and with a high impact on quality of life.
    Prurigo ist eine Hauterkrankung, die mit Juckreiz assoziiert ist und häufig mit einer Beeinflussung der Lebensqualität einhergeht.
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10037084
    E.1.2Term Prurigo nodularis
    E.1.2System Organ Class 100000004858
    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 efficacy of topical treatment with aprepitant on pruritus compared to placebo, after 4 weeks of treatment
    Beeurteilung der Wirksamkeit von topischer Behandlung mit Aprepitant auf den Juckreiz im Vergleich zu Placebo nach 4 Wochen Behandlung
    E.2.2Secondary objectives of the trial
    - efficacy of topical applied aprepitant on the status of the skin condition
    - long-term effect (e.g., duration of action, duration of reduction of pruritus)
    - safety of topical administration of aprepitant
    - levels of substance P in the serum of patients at Screening
    - effect of topical applied aprepitant on skin structures
    - expression of the NK1 receptor, the cellular composition and structure and global gene expression
    - evaluation of skin biopsies for expression of additional targets
    - systemic exposure of aprepitant after topical administration
    - Wirksankeit von topisch applizierten Apepitant auf den Hautzustand
    - Langzeitwirkung (z.B. Dauer der Wirkung, Dauer der Juckreizreduktion)
    - Sicherheit von topischer Applikation von Aprepitant
    - Substanz P Level im Serum bei Patienten zum Screening
    - Effekte von topisch appliziertem Aprepitant auf die Hautstruktur
    - Expression von NK1-Rezeptor, die zelluläre Zusammensetzung und Struktur und die globale Genexpression
    - Beurteilung der Hautproben hinsichtlich der Expression von zusätzlichen Zielstrukturen
    - Systemische Konzentraion nach der topischen Anwendung von Aprepitant
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Signed informed consent has been obtained
    -Patient with Prurigo suffering from chronic pruritus.
    -Disease duration > six month
    -Patients with symmetrical prurigo lesions at upper extremities (both arms) or lower extremities (both legs)
    -Pruritus VAS greater than 6/10 two days before Visit 1 (Screening).
    -Therapy refractory to at least two previous antipruritic treatments with topical, intralesional or systemic corticosteroids, or other immunosuppressant, antihistamines, antipsychotics, antidepressants, anticonvulsants and/or UV-irradiation.
    -Patients need to agree to apply the IMP in accordance with the study protocol. An emollient cream (DAC Basiscreme) serves as rescue medication, which can be applied as often as desired at all body areas.
    -Adult male or female patients, aged 18 to 80 years.
    -Patients will be recruited from inpatient clinic as well as from outpatient clinic.
    -Unterschiebene Einverständniserklärung
    -Patienten mit Prurigo die unter Juckreiz leiden
    -Krankheitsdauer > 6 Monate
    -Patienten mit symmetrischen Prurigo Läsionen an der oberen Extremität (beide Arme) oder der unteren Extremität (beide Beine)
    -Juckreiz VAS größer 6/10 zwei Tage vor Visit 1 (Screening)
    -Therapieresistenz gegenüber mindestens zwei vorherige therapeutische Behandlungen mit topischen, intraläsionalen oder systemischen Steroiden oder anderen Immunsupressiva, Antihistaminika, Antipsychotika, Antidepressiva, Antikonvulsiva und/oder UV-Lichttherapie
    - Patienten müssen zustimmen die IMP entsprechend des Studienprotokolls anzuwenden. Eine Creme (DAC Basiscreme) dient als Notfallmedikation, die so häufig wie gewünscht an allen Körperstellen angewendet werden darf.
    - Erwachsene männliche oder weibliche Patienten zwischen 18 und 80 Jahren.
    - Patienten werden aus der Klinik und aus der Sprechstunde rekrutiert
    E.4Principal exclusion criteria
    - Concomitant medications that are primarily metabolized through CYP3A4
    - Applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin less than 3 weeks prior to Visit 1 (Screening) or during the course of the trial.
    - UV-irradiation during the last 6 weeks prior to the Visit 1 (Screening).
    - Prescribed systemic medications like antihistamines, antidepressants, antipsychotics, corticosteroids are allowed if:
    a. medication was taken at least 4 weeks prior to the trial and
    b. no changes were made concerning the intake or dosage during the last 4 weeks and during the course of the trial.
    - Clinically significant abnormalities in Blood analyses
    - Marked hair density that will interfere with the absorption of IMP in treated areas
    - Anamnestic excessive use of alcohol or tobacco or drugs
    - Presence of active tumor disease or history of malignancies within five years prior to Visit 1 other than a successfully treated non-metastatic cutaneous, basal, or squamous cell carcinoma and/or in situ cancer.
    - Known or suspected hypersensitivity to component(s) of investigational products.
    - Within the last 30 days or current participation in any other interventional clinical trial
    - Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last 6 month.
    - Previously enrolled/randomised in this clinical trial.
    - In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state).
    - Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial or are breast feeding.
    - Females of child-bearing potential with positive pregnancy test.
    - Subjects (or their partner) not using an adequate method of contraception (according to national requirements, as applicable)
    -Begleitmedikation die über CYP3A4 metabolisiert wird
    - Topische Antihistaminika, Kortikosteroide oder MAstzellstabilisatoren kürzer als 3 Wochen vor dem Visit 1 (Screening) oder während der Studie
    - UV-Lichttherapie während der letzten 6 Wochen vor dem Visit 1 (Screening)
    -Verschriebene systemische Medikamente wie Antihistaminika, Antidepressiva, Antipsychotika, Kortikosteroide sind erlaubt, wenn:
    a. Medikamente mindestens 4 Wochen vor der Studie eingenommen wurden und
    b. keine Veränderungen hinsichtlich der Einnahme oder Dosierung in den letzten 4 Wochen und während der Studie gemacht wurden
    - Klinisch signifikante Veränderungen in der Blutanalyse.
    - Verstärkte Behaarung die die Absorption des IMP in den Behandlungsarealen beeinflusst
    - Anamnestisch exessiver Gebrauch von Alkohol und Tabak oder Drogen
    - Aktuelle aktive Tumorerkrankungen oder Tumorerkrankungen in den letzten 5 Jahren vor Visit 1 außer erfolgreich behandelten nichtmetastasierenden kutanen Basalzellkarzinomen, Plattenepithelkarzinomen oder / und in situ Karzinomen
    -Bekannte oder vermutete Überempfindlichkeiten gegenüber Komponenten der verwendeten Studienmedikationen
    -Innerhalb der letzten 30 Tage oder aktuelle Teilnahme an einer anderen interventionellen klinischen Studie
    - Patienten, die eine Behandlung erhalten haben, mit einem nicht vermarkteten Wirkstoff (d.h. ein Mittel, das noch nicht zur Verfügung gestellt wurde nach der Registrierung für den klinischen Einsatz) innerhalb der letzten 6 Monate
    - Zuvor randomisierte Patienten in dieser klinischen Studie
    -Entsprechend der Einschätzung des Prüfers, Patienten, die die Studie nicht entsprechend des Studienprotokolls durchführen (z.B. Alkoholismus, Drogenabhängigkeit oder psychotischen Zustand)
    - Frauen, die schwanger sind oder Frauen im gebärfähigen Alter, die wünschen während der Studie schwanger zu werden oder die stillen
    - Frauen im gebärfähigen Alter die einen positive Schwangerschaftstest haben
    - Patienten (oder deren Partner), die nicht eine angemessene Methode der Empfängnisverhütung (nach nationalen Vorschriften, soweit anwendbar) verwenden
    E.5 End points
    E.5.1Primary end point(s)
    Pruritus
    Juckreiz
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pruritus at end of treatment by VAS
    Juckreiz am Ende der Behandlung bestimmt durch VAS
    E.5.2Secondary end point(s)
    Pruritus at Visits 2, 3 and 5.
    Patient’s assessment of skin condition at each visit and at end of treatment
    Clinical Score at each visit and at end of treatment
    TEWL at Visit 2, 3, 4 and at end of treatment
    Mexameter at Visit 2, 3, 4 and at end of treatment
    Volumetric imaging (in Patients with Prurigo nodularis) at Visit 2, 3, 4 and at end of treatment
    Juckreiz am Visit 2, 3 und 5
    Patienten Beurteilung des Hautzustandes an jedem Besuch und am Ende der Behandlung
    Klinischer Score zu jedem Visit und zum Ende der Behandlung
    TEWL an Visit 2, 3, 4 und am Ende der Behandlung
    Mexameter an Visit 2,3, 4 und am Ende der Behandlung
    Volumetrische MEssungen (bei Patienten mit Prurigo nodularis) an Visit 2, 3, 4 und am Ende der Behandlung
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pruritus at Visits 2, 3 and 5.
    Patient’s assessment of skin condition at each visit and at end of treatment by treatment area.
    Clinical Score at each visit and at end of treatment
    TEWL at Visit 2, 3, 4 and at end of treatment
    Mexameter at Visit 2, 3, 4 and at end of treatment
    Volumetric imaging (in Patients with Prurigo nodularis) at Visit 2, 3, 4 and at end of treatment
    Juckreiz am Visit 2, 3 und 5
    Patienten Beurteilung des Hautzustandes an jedem Besuch und am Ende der Behandlung
    Klinischer Score zu jedem Visit und zum Ende der Behandlung
    TEWL an Visit 2, 3, 4 und am Ende der Behandlung
    Mexameter an Visit 2,3, 4 und am Ende der Behandlung
    Volumetrische MEssungen (bei Patienten mit Prurigo nodularis) an Visit 2, 3, 4 und am Ende der Behandlung
    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 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
    intraindividueller rechts/links Vergleich
    intraindividual left/right 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.8.2.4Number 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
    last visit of the last subject
    Letzter 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
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 18
    F.1.3Elderly (>=65 years) Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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 Decision2013-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-28
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