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    Summary
    EudraCT Number:2016-004573-40
    Sponsor's Protocol Code Number:1368.15
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-04
    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 number2016-004573-40
    A.3Full title of the trial
    Multi-center, double-blind, randomised, placebo-controlled, phase IIa study to investigate efficacy, safety, tolerability, pharmacokinetics and
    pharmacogenomics of multiple intravenous doses of BI 655130 in patients with Palmoplantar Pustulosis (PPP)
    Studio di fase IIa multicentrico, in doppio cieco, randomizzato e controllato con placebo volto a valutare l'efficacia, la sicurezza, la tollerabilit¿, la farmacocinetica e la farmacogenomica di dosi multiple per via endovenosa di BI 655130 in pazienti affetti da pustolosi palmo-plantare (PPP).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Initial Dosing of BI 655130 in Palmoplantar Pustulosis patients
    Dosaggio iniziale di BI 655130 in pazienti affetti da pustolosi palmo-plantare (PPP).
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code number1368.15
    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 SponsorBOEHRINGER-INGELHEIM ITALIA 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 supportBoehringer Ingelheim Italia Spa
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number0018002430127
    B.5.5Fax number0018008217119
    B.5.6E-mailclintriage.rdg@boehringeringelheim.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 nameBI 655130
    D.3.2Product code BI 655130
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeBI 655130
    D.3.9.4EV Substance CodeSUB31544
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Palmoplantar Pustulosis
    pustolosi palmo-plantare (PPP)
    E.1.1.1Medical condition in easily understood language
    Palmoplantar Pustulosis
    pustolosi palmo-plantare (PPP)
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10050185
    E.1.2Term Palmoplantar pustulosis
    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
    The primary objective of this trial is to investigate the safety and efficacy of BI 655130 in patients with PPP following multiple intravenous administrations compared to placebo.
    L'obiettivo primario di questa sperimentazione ¿ valutare la sicurezza e l'efficacia, rispetto al placebo, di BI 655130 in pazienti affetti da PPP
    E.2.2Secondary objectives of the trial
    Further objectives are the assessment of the pharmacokinetics of BI 655130 after multiple dosing in patients with PPP as well as the exploration of pharmacogenomics and the evaluation of surrogate
    markers.
    Ulteriori obiettivi sono la valutazione della farmacocinetica di BI
    655130 dopo somministrazioni multiple in pazienti con PPP, nonche la esplorazione farmacogenomica e la valutazione di marker surrogati
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female patients, 18 to 65 years of age at screening.
    - Palmoplantar Pustulosis
    - Further criteria apply

    1. Consenso informato scritto firmato e datato prima dell'avvio di qualsiasi procedura di screening, conformemente alle norme di Buona Pratica Clinica (Good Clinical Practice, GCP) e alla legislazione locale.
    2. Pazienti di sesso maschile o femminile di età compresa tra 18 e 65 anni allo screening.
    3. Pustolosi palmo-plantare, definita come presenza di pustole primarie, visibili macroscopicamente, sterili e persistenti (durata >3 mesi) sui palmi delle mani e/o sulle piante dei piedi, con o senza psoriasi a placche su meno del 10% dell'area di superficie corporea (BSA).
    4. Presenza di pustole attive (pustole gialle) sui palmi delle mani e/o sulle piante dei piedi.
    5. Punteggio ppPASI (Indice di gravità ed estensione della psoriasi pustolosa palmo-plantare (palmo-plantar pustular Psoriasis Area Severity Index)) minimo pari a 12 e gravità almeno moderata secondo la pppPGA (Valutazione globale del medico della pustolosi palmo-plantare (palmo-plantar pustular Physician's Global Assessment)) al basale.
    6. Le donne fertili (Women Of Childbearing Potential, WOCBP) e gli uomini in grado di concepire un figlio devono usare metodi contraccettivi altamente efficaci ai sensi dell'ICH M3 (R2), ovvero con un tasso di fallimento basso, inferiore all'1% all'anno, se utilizzati in modo costante e corretto. Il foglio informativo per il paziente contiene un elenco dei metodi contraccettivi che soddisfano i suddetti criteri.
    E.4Principal exclusion criteria
    - Patients with associated plaque psoriasis = 10% of the body surface
    area.
    - Presence or known history of anti-TNF-induced PPP-like disease.
    - Active or latent tuberculosis
    - Further criteria apply
    1.Pazienti con psoriasi a placche concomitante su =10% dell'area di superficie corporea.
    2.Donne in gravidanza, allattamento o che prevedono di avviare una gravidanza durante la sperimentazione.
    3.Malattia renale, epatica, ematologica, endocrina, polmonare, cardiaca, neurologica, cerebrale o psichiatrica grave, progressiva o non controllata, o relativi segni e sintomi.
    4.Presenza o anamnesi nota di una patologia simile alla PPP indotta da anti-TNF.
    5.Pazienti con sindrome SAPHO (sinovite-acne-pustolosi-iperostosi-osteite).
    6.Pazienti con un organo trapiantato (fatta eccezione per il trapianto di cornea eseguito >12 settimane prima dello screening) o che hanno ricevuto una terapia con cellule staminali (ad esempio Prochymal).
    7.Anamnesi nota di malattia linfoproliferativa, compreso il linfoma, o segni e sintomi indicativi di una possibile malattia linfoproliferativa, quali linfoadenopatia e/o splenomegalia.
    8.Qualsiasi neoplasia maligna documentata attiva o sospetta o anamnesi di neoplasia maligna nei 5 anni precedenti alla visita di screening, ad eccezione del carcinoma cutaneo a cellule basali o squamose adeguatamente trattato o del carcinoma in situ della cervice uterina.
    9.Pazienti sottoposti in precedenza ad immunoterapia antiallergica per la prevenzione di reazioni anafilattiche.
    10.Uso di un qualsiasi farmaco soggetto a restrizione, come specificato nella tabella 4.2.2.1: 1 o qualsiasi farmaco ritenuto in grado di interferire con lo svolgimento sicuro dello studio secondo la valutazione dello sperimentatore.
    11.Somministrazione in programma di vaccini vivi durante il periodo di studio o nelle 6 settimane precedenti alla randomizzazione.
    12.Anamnesi di allergia/ipersensibilità ad un agente biologico somministrato per via sistemica o ai suoi eccipienti.
    13.Infezioni sistemiche attive (ad eccezione del raffreddore comune) nelle ultime 2 settimane prima della randomizzazione, secondo la valutazione dello sperimentatore.
    14.Infezioni acute rilevanti o croniche, ivi compresi il virus dell'immunodeficienza umana (HIV), l'epatite virale e/o la tubercolosi attiva o latente (sono esclusi i pazienti con test QuantiFERON TB positivo, mentre i pazienti con risultato falso positivo sospetto o indeterminabile possono essere sottoposti nuovamente al test).
    15.Intervento chirurgico maggiore eseguito nelle 12 settimane precedenti alla randomizzazione o previsto nelle 32 settimane dopo la randomizzazione (ad esempio protesi d'anca, rimozione di un aneurisma, legatura dello stomaco), secondo la valutazione dello sperimentatore.
    16.Conta linfocitaria totale (White Blood Count, WBC) <3.000/µl, o conta piastrinica <100.000/µl o conta dei neutrofili <1.500/µl, o emoglobina <8,5 g/dl allo screening.
    17.Aspartato aminotransferasi (AST) o alanina aminotransferasi (ALT) >2 volte il limite superiore della norma, oppure bilirubina totale >1,5 volte il limite superiore della norma (non sono esclusi i pazienti con sindrome di Gilbert) allo screening.
    18.Partecipazione in corso ad un altro studio su un farmaco o un dispositivo sperimentale, o un lasso di tempo trascorso dal termine di un altro studio su un farmaco o un dispositivo sperimentale inferiore a 30 giorni o ricezione corrente di altri trattamenti sperimentali.
    19.Abuso cronico di droga o alcol o qualsiasi condizione che, a giudizio dello sperimentatore, rende il paziente un soggetto dello studio inaffidabile o che probabilmente non completerà la sperimentazione.
    20.Randomizzazione precedente in questa sperimentazione.
    E.5 End points
    E.5.1Primary end point(s)
    1) Efficacy: ppPASI50 at week 16
    2) Safety: Number of patients with drug-related AEs
    1)Efficacia: ppPASI50 alla Settimana 16
    2)Sicurezza: numero di pazienti che hanno sperimentato eventi avversi correlati al farmaco
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) 16 weeks
    2) 16 weeks
    1) 16 settimane
    2) 16 settimane
    E.5.2Secondary end point(s)
    1) Treatment success defined as achieving a clinical response of 0 or
    1=clear/almost clear via PPP Physicians Global Assessment (pppPGA) at
    week 16
    2) ppPASI75 at week 16
    3) Percent change from baseline in the ppPASI at week 16
    1)Successo del trattamento, definito come il raggiungimento di una risposta clinica pari a 0 o 1 = malattia assente/quasi assente secondo la pppPGA alla Settimana 16
    2)ppPASI75 alla Settimana 16
    3)Variazione percentuale rispetto al basale del ppPASI alla Settimana 16
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) 16 weeks
    2) 16 weeks
    3) 16 weeks
    1) 16 settimane
    2) 16 settimane
    3) 16 settimane
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    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 trial3
    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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Denmark
    Germany
    Italy
    Spain
    Sweden
    E.8.7Trial has a data monitoring committee Yes
    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 years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days14
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 53
    F.4.2.2In the whole clinical trial 60
    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)
    Treatment as prescribed by clinician
    Trattamento in accordo alle decisioni dello sperimentatore
    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 Decision2017-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-17
    P. End of Trial
    P.End of Trial StatusCompleted
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