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    Summary
    EudraCT Number:2013-003666-13
    Sponsor's Protocol Code Number:1311.8
    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:2013-11-11
    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 number2013-003666-13
    A.3Full title of the trial
    A 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis.
    Studio clinico di fase II, randomizzato, in doppio cieco, controllato verso placebo, di 48 settimane, per confermare l’attivita' preliminare (proof of concept) e selezionare la dose tra tre differenti regimi di BI 655066 somministrato sottocute in pazienti con spondilite anchilosante.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BI 655066 proof of concept dose finding study in AS
    Studio per confermare l’attivita' preliminare (proof of concept) e selezionare la dose di BI 655066 in pazienti con spondilite anchilosante.
    A.4.1Sponsor's protocol code number1311.8
    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
    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 s.p.a.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    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 number+1 800 243 0127
    B.5.5Fax number+1 800 821 7119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 655066 90 mg/ml
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN.A.
    D.3.9.2Current sponsor codeBI 655066
    D.3.9.3Other descriptive nameBI 655066
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 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 Yes
    D.3.11.13.1Other medicinal product typeHumanized IgG monoclonal antibody
    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 injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ankylosing Spondylitis
    spondilite anchilosante
    E.1.1.1Medical condition in easily understood language
    Ankylosing spondylitis
    spondilite anchilosante
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10002557
    E.1.2Term Ankylosing spondylitis and other inflammatory spondylopathies
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective is to compare efficacy of BI 655066 versus placebo at 12 weeks, based on ASAS 40 response criteria.
    L’obiettivo principale è confrontare l’efficacia di BI 655066 verso placebo alla dodicesima settimana di trattamento, basandosi sui criteri di risposta ASAS (determinazione della società internazionale di spondilo-artrite) 40.
    E.2.2Secondary objectives of the trial
    To compare efficacy of BI 655066 versus placebo at 24 weeks, based on change in ASDAS score (key secondary)
    To compare efficacy of BI 655066 versus placebo at 24 weeks, based on ASAS 40 response criteria; To compare efficacy of BI 655066 versus placebo at 24 weeks based on ASAS 20, ASAS 5/6, ASAS remission criteria, change in BASDAI score
    Confrontare l'efficacia di BI 655066 rispetto al placebo a 24 settimane, sulla base di cambiamenti nel punteggio ASDAS (key secondary). Confrontare l'efficacia di BI 655066 rispetto al placebo a 24 settimane, in base a criteri di risposta ASAS 40. Confrontare l'efficacia di BI 655066 rispetto al placebo alla 24 settimane sulla base di ASAS 20, ASAS 5/6, i criteri di remissione ASAS, cambiamento del punteggio BASDAI
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male and female patients
    -Age >= 18 years and =< 70 years.
    -Definite AS based on the modified New York criteria (1984)
    -Documented disease duration > 3 months at screening
    -Active disease at screening, defined as:
    --BASDAI score (0-10) >= 4, AND
    --Spinal pain level assessed by patient on NRS (0-10) >= 4 (2nd question from BASDAI will be used here)
    -Have either a documented inadequate response for axial symptoms to 30 days of optimal daily doses of at least two non-steroidal anti-inflammatory drugs (NSAIDs), or documented intolerance to NSAIDs
    1.Maschi e femmine
    2.Eta' allo screening di 18-70 anni compresi
    3.Diagnosi di spondilite anchilosante basata sui criteri modificati di New York (1984)
    4.Durata della malattia di almeno tre mesi, documentata allo screening
    5.Malattia attiva allo screening, definita come: punteggio BASDAI (0-10) >= 4 e livello di dolore spinale determinato dalla seconda domanda del questionario BASDAI (0-10) > =4
    6.Documentata risposta inadeguata per i sintomi assiali dopo trenta giorni di una dose giornaliera ottimale di almeno due trattamenti anti-infiammatori non-steroidei o documentata intolleranza ai trattamenti anti-infiammatori non-steroidei
    7.Livelli di proteina C reattiva (CRP) maggiori del limite superiore di normalità secondo i riferimenti del laboratorio centralizzato usato nella sperimentazione
    8.Femmine che rispettano almeno uno dei seguenti criteri dalla visita di screening alla visita di fine osservazione: uso di un adeguato metodo di contraccezione (contraccettivi impiantati, iniettabili o combinazioni orali) oltre al profilattico, astinenza sessuale, partner vasectomizzato da almeno un anno prima dello screening, sterili chirurgicamente (inclusa isterectomia), menopausa definita da almeno un anno di amenorrea spontanea (in casi dubbi il livello dell’ormone stimolatore del follicolo deve essere > 40U/L e quello dell’estradiolo < 30ng/L)
    9.Maschi o femmine che assumono metotrexate o leflunomide e che seguono le linee guida nazionali per la contraccezione
    10.Consenso informato firmato e datato in conformità alle GCP e alle normative locali prima della partecipazione alla sperimentazione
    E.4Principal exclusion criteria
    -Radiographic evidence of total ankylosis of the spine at screening or before (spinal X-Ray examinations at screening visit/ during screening period are not mandatory - see footnote 12 from Flow-Chart 1).
    -Patient previously treated with any biological immunomodulating agent for AS, either licensed or experimental
    -Previous or current participation in a clinical trial testing an investigational drug for AS
    -Usage of any investigational drug within 30 days prior to randomization or the planned use of an investigational drug during the course of the actual study
    -Active uveitis or inflammatory bowel disease at screening
    -Diagnosed psoriatic arthritis at screening, satisfying the modified New York criteria
    -Patients who had received intraarticular injection(s) with corticosteroids within 4 weeks prior to screening visit
    1.Evidenza radiografica della totale anchilosi alla spina dorsale prima dello screening oppure allo screening
    2.Trattamento precedente con qualsiasi agente immunomodulatore per la spondilite anchilosante, sperimentale oppure già disponibile sul mercato
    3.Partecipazione precedente o attuale ad una sperimentazione clinica per valutare un farmaco sperimentale per la spondilite anchilosante
    4.Utilizzo di farmaco sperimentale nei 30 giorni prima della randomizzazione o prevista somministrazione di farmaco sperimentale durante il periodo di partecipazione a questo studio.
    5.Presenza allo screening di uveite attiva oppure di una malattia infiammatoria dell’intestino
    6.Diagnosi allo screening di artrite psorica che soddisfa i criteri modificati di New York
    7.Almeno una iniezione intra-articolare con corticosteroidi nelle quattro settimane prima dello screening
    8.Necessita' o volontà di assumere farmaci non consentiti dalle procedure di studio o di altri farmaci che potrebbero interferire con la partecipazione in sicurezza della sperimentazione
    9.Importati interventi chirurgici effettuati nelle otto settimane prima dello screening o pianificati nei dodici mesi dopo lo screening
    10.Presenza di infezioni croniche o acute rilevanti incluso HIV, epatite virale e tubercolosi
    11.Presenza o sospetta presenza di tumore maligno attivo o passato, negli ultimi 5 anni prima dello screening, ad eccezione di basalioma della cute o carcinoma della cervice in situ opportunamente trattati
    12.Attiva o pregressa condizione clinica significativa, diversa dalla spondilite anchilosante, o evidenze dell’esame obiettivo (incluso segni vitali ed ECG) o parametri di laboratorio significativamente fuori dai valori di normalità che, secondo lo sperimentatore, potrebbe mettere a rischio la sicurezza del paziente oppure compromettere la qualita' dei dati, questo criterio fornisce la possibilità di escludere la partecipazione del paziente sulla base del giudizio clinico anche se gli altri criteri di elegibilità sono rispettati
    13.Anamnesi di allergia o ipersensitività agli agenti biologici somministrati per via sistemica oppure ai loro eccipienti
    14.Anamnesi di abuso etilico negli ultimi dodici mesi (assunzione di più di 30 g al giorno)
    15.Anamnesi di abuso di sostanze illecite negli ultimi dodici mesi oppure test alle droghe positivo allo screening
    E.5 End points
    E.5.1Primary end point(s)
    1: ASAS 40 response
    l’endpoint primario di efficacia è la risposta ASAS 40
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: Week 12
    alla dodicesima settimana di trattamento
    E.5.2Secondary end point(s)
    1: Change in ASDAS score as compared to baseline (Key Secondary)

    2: ASAS 5/6 response

    3: ASAS remission criteria

    4: ASAS 20 response

    5: ASAS 40 response

    6: Change in BASDAI score as compared with baseline
    1) l’endpoint principale secondario di efficacia è la modifica del punteggio ASDAS confrontata con il punteggio al basale.
    2) la risposta ASAS 5/6
    3) la parziale remissione ASAS,
    4) la risposta ASAS 20
    5) la risposta ASAS 40,
    6) la modifica del punteggio BASDAI alla dodicesima settimana di trattamento confrontata con il punteggio al basale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: Week 12

    2: Week 12

    3: Week 12

    4: Week 12

    5: Week 24

    6: Week 12
    1) alla dodicesima settimana di trattamento
    2) alla dodicesima settimana di trattamento
    3) alla dodicesima settimana di trattamento
    4) alla dodicesima settimana di trattamento
    5) alla ventiquattresima settimana di trattamento
    6) alla dodicesima settimana di trattamento
    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 No
    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 Yes
    E.8.2.3.1Comparator description
    Dose Comparision
    Dose Comparision
    E.8.2.4Number of treatment arms in the trial4
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Finland
    France
    Germany
    Hong Kong
    Italy
    Korea, Republic of
    Netherlands
    Spain
    Taiwan
    United States
    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 years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days29
    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: 150
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 127
    F.4.2.2In the whole clinical trial 212
    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)
    N.A.
    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 Decision2014-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-26
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