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    Summary
    EudraCT Number:2011-000756-42
    Sponsor's Protocol Code Number:MEX0111
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-03-20
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-000756-42
    A.3Full title of the trial
    A phase 2, multicentre, single arm, pilot study to assess the efficacy and the safety of 150 mg twice a day oral DF2156A in patients with active bullous pemphigoid.
    Studio pilota di fase 2, multicentrico, a singolo gruppo per valutare l'efficacia e la sicurezza del DF2156A, 150 mg due volte al giorno per via orale, nei pazienti con pemfigoide bolloso in fase attiva.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    pilot phase 2 clinical trial performed in some hospitals to evaluate the efficacy and the adverse events in a group of patients with active bullous pemphigoid that will receive DF2156A at the dose of 150 mg, oral route, twice a day.
    studio clinico pilota di fase 2 da condursi in piu' ospedali per valutare l'efficacia e gli effetti collaterali in un gruppo di pazienti con pemfigoide bolloso in fase attiva che riceveranno il DF2156A alla dose di 150 mg per via orale due volte al giorno
    A.3.2Name or abbreviated title of the trial where available
    DF2156A in bullous pemphigoid
    DF2156A nel pemfigoide bolloso
    A.4.1Sponsor's protocol code numberMEX0111
    A.5.4Other Identifiers
    Name:NPNumber:NP
    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 SponsorDOMPE' s.p.a.
    B.1.3.4CountryItaly
    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 supportDompe' spa
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDompe' spa
    B.5.2Functional name of contact pointClinical Pharmacology Unit
    B.5.3 Address:
    B.5.3.1Street AddressVia San Martino 12
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20122
    B.5.3.4CountryItaly
    B.5.4Telephone number02 58383500
    B.5.5Fax number02 58383324
    B.5.6E-mailpieradelchi.ruffini@dompe.it
    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 nameNA
    D.3.2Product code DF2156A
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNladarixin
    D.3.9.1CAS number 865625-56-5
    D.3.9.2Current sponsor codeDF2156A
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    active bullous pemphigoid
    pemfigoide bolloso in fase attiva
    E.1.1.1Medical condition in easily understood language
    --
    --
    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 10006567
    E.1.2Term Bullous pemphigoid
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    evaluate whether DF2156A has a potential in improving the clinical outcome in patients with active blistering BP to warrant its further development and the safety of DF2156A in the specific clinical setting
    valutare se il DF2156A ha un potenziale nel migliorare l'esito clinico in pazienti con PB in fase bollosa attiva da supportare un suo ulteriore sviluppo e valutare la tollerabilita' del DF2156A nell'ambito clinico specifico
    E.2.2Secondary objectives of the trial
    NP
    NP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Consented male and female patients aged >50 years with newly diagnosed or relapsing bullous pemphigoid (clinical diagnosis to be confirmed by direct immunofluorescence and indirect immunofluorescence on salt-spit skin or BP180 and/or BP230 ELISA) will be included. Patients must have mild to moderate active blistering disease (total number of blisters between 1 and 30) whether associated or not with urticarial/eczematous lesions and a modified ABSIS score ≤50. Patients must be free from any systemic treatments that may affect the course of the disease (off-period prior to enrolment: 3 weeks for steroids, dapsone, tetracyclines, nicotinamide; 3 months for azathioprine, mycofenolate mofetil, cyclophosphamide, methotrexate, intravenous immunoglobulins, immunoadsorption, TNF antagonists; 12 months for rituximab, leflunomide). They must also be free from any topical treatments other than topical antibiotics and antiseptics in the 4 days prior to enrolment.
    Saranno inclusi pazienti di entrambi i sessi che abbiano dato il consenso informato, di età &gt;50 anni con PB di nuova diagnosi o recidivante (la diagnosi clinica deve essere confermata tramite immunofluorescenza diretta e indiretta o saggio ELISA per BP180 e/o BP230). I pazienti devono avere patologia in fase attiva di grado lieve o moderato (numero totale di bolle compreso tra 1 e 30), associata o meno a lesioni orticarioidi/eczematose e un ABSIS score modificato &lt;= 50. I pazienti non devono assumere nessun farmaco sistemico che potrebbe modificare l'evoluzione della patologia (periodo di assenza da questi trattamenti prima dell'arruolamento: 3 settimane per steroidi, dapsone, tetracicline, nicotinamide; 3 mesi per azatioprina, micofenolato mofetile, ciclofosfamide, metotrexate, immunoglobuline intravenose, immunoassorbimento, antagonisti del TNF; 12 mesi per rituximab e leflunomide). Non devono inoltre essere trattati con alcun farmaco topico ad eccezione degli antibiotici e degli antisettici nei 4 giorni precedenti l’arruolamento.
    E.4Principal exclusion criteria
    Patients will be excluded if they have a Karnofsky rating score <40% and a mucosal involvement. Patients who have moderate to severe renal impairment (calculated creatinine clearance < 50 mL/min according to the Cockcroft-Gault formula) or hepatic dysfunction (increased ALT/AST > 3 x upper limit of normal and increased total bilirubin > 3 mg/dL [>51.3 μmol/L]) or hypoalbuminemia (serum albumin < 3 g/dL) or a QTcF > 470 msec or had a myocardial infarction in the previous 6 months will be excluded as well. Patients will be excluded if they are on treatment with phenytoin, warfarin, sulphanylurea hypoglycemics and high dose of amitriptyline (> 50 mg/day); if they have a known hypersensitivity to non-steroidal antiinflammatory drugs; if they received an investigational product in the 12 months prior to enrolment. Also, pregnant or breast feeding women or patients unwilling to use effective contraceptive measures (females and males) will be excluded.
    Saranno esclusi dallo studio i pazienti che hanno uno score di Karnofsky &lt;40% e un coinvolgimento mucosale. Inoltre, saranno esclusi i pazienti con disfunzione renale moderata o severa (clearance della creatinina calcolata secondo la formula di Cockcroft-Gault &lt; 50 mL/min); disfunzione epatica (ALT/AST superiori di tre volte il limite superiore di normalità e bilirubina totale &gt; 3 mg/dL [&gt;51.3 μmol/L]); ipoalbuminemia (albumina serica &lt; 3 mg/dL); un QTcF &gt; 470 msec; pazienti che abbiano avuto un infarto del miocardio nei 6 mesi precedenti. Saranno esclusi pazienti in trattamento con fenitoina, warfarin, ipoglicemizzanti sulfanilureici e alte dosi di amitriptilina (&gt; 50 mg al giorno); con ipersensibilità nota agli antiinfiammatori non-steroidei; che abbiano ricevuto un farmaco sperimentale nei 12 mesi antecedenti l'arruolamento. Inoltre, saranno escluse le donne in stato di gravidanza o in allattamento o pazienti (donne e uomini) che non desiderano utilizzare un metodo efficace di contraccezione.
    E.5 End points
    E.5.1Primary end point(s)
    Total number of blisters and percent change from baseline; Modified ABSIS score and percent change from baseline; PGA score measured on a 0-10 scale, absolute value and % change from baseline; Pruritus measured on a 10 cm visual analogue scale, absolute value and percent change from baseline; Eosinophil blood count, absolute number and percent change from baseline; Number and percentage of patients with treatment failure (drug discontinuation due to lack of improvement); Number and percentage of patients completely free from blisters; Number of patients who are still free from blisters without requiring any systemic or topical rescue treatment - Optional
    Numero totale di bolle e variazione percentuale rispetto al basale; ABSIS score modificato e variazione percentuale rispetto al basale; PGA score misurato su una scala 0-10, valore assoluto e variazione percentuale rispetto al basale; Prurito misurato su una scala analogico-visiva di 10 cm, valore assoluto e variazione percentuale rispetto al basale; Conta degli eosinofili ematici, valore assoluto e variazione percentuale rispetto al basale; Numero e percentuale di pazienti con fallimento del trattamento (Prodotto in studio interrotto a causa di mancanza di miglioramento); Numero e percentuale di pazienti completamente liberi da bolle; Numero e percentuale di pazienti che rimangono liberi da bolle senza necessità di trattamenti di soccorso sistemici e topici - Opzionale
    E.5.1.1Timepoint(s) of evaluation of this end point
    time frame: day 0/1 (pre-dose), 8 and 15; time frame: day 0/1 (pre-dose), 8 and 15; time frame: day 0/1 (pre-dose), 8 and 15; time frame: day 0/1 (pre-dose), 8 and 15; time frame: screening and day 15; time frame: day 8; time frame: day 15; time frame: day 30
    tempistica: giorno 0/1 (pre-dose), 8 e 15; tempistica: giorno 0/1 (pre-dose), 8 e 15; tempistica: giorno 0/1 (pre-dose), 8 e 15; tempistica: giorno 0/1 (pre-dose), 8 e 15; tempistica: screening e giorno 15; tempistica: giorno 8; tempistica: giorno 15; tempistica: giorno 30
    E.5.2Secondary end point(s)
    NP
    NP
    E.5.2.1Timepoint(s) of evaluation of this end point
    NP
    NP
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    LVLS
    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 months13
    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 months13
    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.1.1Number of subjects for this age range: 0
    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: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 12
    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)
    NP
    NP
    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 Decision2011-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-07-11
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