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    Summary
    EudraCT Number:2019-004167-45
    Sponsor's Protocol Code Number:1305-0013
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-17
    Trial 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 number2019-004167-45
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally.
    Studio randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli di 12 settimane, su pazienti con fibrosi polmonare idiopatica volto a valutare efficacia, sicurezza e tollerabilità di BI 1015550 somministrato per via orale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF).
    Studio per valutare come BI 1015550, preso per 12 settimane, influisca sulle funzionalità polmonari di pazienti con fibrosi polmonare idiopatica
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code number1305-0013
    A.5.4Other Identifiers
    Name:-Number:-
    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 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 pointCT Disclosure and Data Transparency
    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+18002430127
    B.5.5Fax number+18008217119
    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 name-
    D.3.2Product code [BI 1015550]
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.9.2Current sponsor codeBI 1015550
    D.3.9.3Other descriptive nameBI 1015550
    D.3.9.4EV Substance CodeSUB187131
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 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.IMP: 2
    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 name-
    D.3.2Product code [BI 1015550]
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.9.2Current sponsor codeBI 1015550
    D.3.9.3Other descriptive nameBI 1015550
    D.3.9.4EV Substance CodeSUB187131
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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 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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic Pulmonary Fibrosis
    fibrosi polmonare idiopatica
    E.1.1.1Medical condition in easily understood language
    Idiopathic Pulmonary Fibrosis
    fibrosi polmonare idiopatica
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To investigate the efficacy of BI 1015550 compared to placebo based on the change from baseline in Forced Vital Capacity (FVC).
    - To investigate safety and tolerability of BI 1015550 in the overall trial population.
    Studiare l’efficacia di BI 1015550 18 mg due volte/die a confronto con il placebo in base alla variazione rispetto al basale della FVC (capacità vitale forzata, Forced Vital Capacity). Studiare la sicurezza e la tollerabilità di BI 1015550 nella popolazione complessiva dello studio.
    E.2.2Secondary objectives of the trial
    Not applicable
    Non Applicabile
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: -Digital lung Auscultation Test (substudy at dedicated sites only) Electronic recordings of lung auscultation sounds will be collected
    -24 hr Cough measurement (substudy at dedicated sites only) 24 hr record of patient's daily sound will be collected via a device installed on the patient

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Procedure opzionali sulla registrazione dei suoni polmonari e per la valutazione della tosse delle 24 ore che saranno attivate successivamente e comporteranno la sottomissione di consensi informati specifici
    E.3Principal inclusion criteria
    - Patients aged >=40 years when signing the informed consent.
    - Diagnosis:
    -- a. IPF based on 2018 ATS/ERS/JRS/ALAT Guideline [R18-2794] as
    confirmed by the investigator based on chest HRCT scan taken within 12
    months of Visit 1 and if available surgical lung biopsy. and
    -- b. UIP or probable UIP HRCT pattern consistent with the clinical
    diagnosis of IPF
    - Stable for at least 8 weeks prior to Visit 1. Patients have to be either :
    -- not on therapy with nintedanib or pirfenidone for at least 8 weeks
    prior to Visit 1 (combination of nintedanib plus pirfenidone not allowed),
    or
    -- on stable* therapy with nintedanib or pirfenidone for at least 8 weeks
    prior to Visit 1 and planning to stay stable on this background therapy
    after randomisation.
    - Forced Vital Capacity (FVC) >=45% of predicted normal at Visit 1
    - DLCO (corrected for haemoglobin [Hb] [Visit 1]) >= 25% to < 80% of
    predicted normal at Visit 1.
    - Signed and dated written informed consent in accordance with ICHGCP
    and local legislation prior to admission to the trial.
    1. Pazienti di età >=40 anni che abbiano firmato il consenso informato.
    2. Diagnosi: per informazioni dettagliate, si veda anche l’Appendice 10.5
    a. IPF secondo le linee guida ATS/ERS/JRS/ALAT 2018 [R18-2794], come confermato dallo sperimentatore in base all’HRCT del torace eseguita nei 12 mesi precedenti la Visita 1 e alla biopsia polmonare chirurgica, se disponibile.
    e
    b. Pattern UIP o probabile pattern UIP all’HRCT compatibile con la diagnosi clinica di IPF, come confermato dalla revisione centralizzata prima della Visita 2*
    *in caso di un reperto indeterminato all’HRCT, l’IPF può essere confermata a livello locale mediante biopsia (storica)
    3. Stabili da almeno 8 settimane prima della Visita 1. I pazienti devono essere:
    • non in terapia con nintedanib o pirfenidone da almeno 8 settimane prima della Visita 1 (non è consentita l’associazione di nintedanib e pirfenidone), oppure
    • in terapia stabile* con nintedanib o pirfenidone da almeno 8 settimane prima della Visita 1 e con previsione di proseguire stabilmente questa terapia di base dopo la randomizzazione.
    [*si definisce “terapia stabile” il regime di trattamento con pirfenidone o nintedanib generalmente tollerato dal singolo paziente]
    4. Capacità vitale forzata (FVC) >=45% del normale predetto alla Visita 1
    5. DLCO (capacità di diffusione per il monossido di carbonio (Diffusion capacity of the Lung for Carbon monoxide)) (corretta per l’emoglobina [Hb] [Visita 1]) da >=25% a <80% del normale predetto alla Visita 1.
    6. Pazienti che abbiano datato e firmato il consenso informato secondo i principi di GCP dell’ICH e la legislazione locale prima dell’ammissione nello studio.
    E.4Principal exclusion criteria
    - Relevant airways obstruction (pre-bronchodilator FEV1/FVC < 0.7) at
    Visit 1.
    - In the opinion of the Investigator, other clinically significant pulmonary
    abnormalities.
    - Acute IPF exacerbation within 4 months prior to screening and/or
    during the screening period (investigator-determined).
    - Lower respiratory tract infection requiring antibiotics within 4 weeks
    prior to Visit 1 and/or during the screening period.
    - Major surgery (major according to the investigator's assessment)
    performed within 3 months prior to Visit 1 or planned during the course
    of the trial. (Being on a transplant list is allowed).
    - Any documented active or suspected malignancy or history of
    malignancy within 5 years prior to Visit 1, except appropriately treated
    basal cell carcinoma of the skin, "under surveillance" prostate cancer or
    in situ carcinoma of uterine cervix.
    - Evidence of active infection (chronic or acute) based on clinical exam
    or laboratory findings (see table 5.2.3 :1) at Visit 1 or at Visit 2.
    - Any suicidal behaviour in the past 2 years (i.e. actual attempt,
    interrupted attempt, aborted attempt, or preparatory acts or behavior).
    - Further criteria apply.
    1. Ostruzione delle vie aeree rilevante (FEV1 (volume espiratorio forzato in un secondo)/FVC <0,7 prima della broncodilatazione) alla Visita 1.
    2. Altre anomalie polmonari clinicamente significative secondo il giudizio dello sperimentatore.
    3. Riacutizzazione acuta dell’IPF nei 4 mesi precedenti lo screening e/o durante il periodo di screening (determinata dallo sperimentatore).
    4. Infezione delle basse vie respiratorie che richiede l’impiego di antibiotici nelle 4 settimane precedenti la Visita 1 e/o durante il periodo di screening.
    5. Intervento di chirurgica maggiore (“maggiore” secondo la valutazione dello sperimentatore) eseguito nei 3 mesi precedenti la Visita 1 o programmato nel corso della sperimentazione. (È consentita la partecipazione di pazienti in lista per trapianto).
    6. Qualsiasi neoplasia maligna in atto documentata o sospetta o anamnesi positiva per neoplasia maligna nei 5 anni precedenti la Visita 1, a eccezione di forme adeguatamente trattate di carcinoma cutaneo basocellulare, carcinoma prostatico “sotto sorveglianza” o carcinoma in situ della cervice uterina.
    7. Evidenze di infezione in atto (cronica o acuta) secondo l’esame clinico o i reperti di laboratorio (si veda la Tabella 5.2.3 :1) alla Visita 1 o alla Visita 2.
    8. Comportamenti suicidari negli ultimi 2 anni (ovvero, tentativo concreto, tentativo interrotto, tentativo fallito, oppure comportamenti o atti preparatori).
    9. Ideazioni suicidarie di tipo 4 o 5 secondo la C-SSRS (Columbia Suicidal Severity Rating Scale) negli ultimi 3 mesi o alla Visita 1 (ovvero, ideazione suicidaria attiva con un metodo e intenzione di agire, ma senza un piano specifico; oppure ideazione suicidaria attiva con un metodo, un piano e con intenzione).

    Per altri criteri fare riferimento alla sinossi del protocollo in italiano
    E.5 End points
    E.5.1Primary end point(s)
    1) The primary endpoint is the change from baseline in FVC
    1) L’endpoint primario è la variazione rispetto al basale della FVC
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) 12 weeks
    1) 12 settimane
    E.5.2Secondary end point(s)
    1) The percentage N (%) of patients with Treatment Emergent Adverse
    Events (TEAE).
    1) L’endpoint secondario è la percentuale di pazienti (%) N con eventi avversi emersi durante il trattamento (Treatment Emergent Adverse Events, TEAE).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) 13 weeks
    1) 13 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 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 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 trial2
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA63
    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
    Australia
    Austria
    Canada
    China
    Czechia
    Denmark
    Finland
    France
    Germany
    Greece
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Russian Federation
    Slovakia
    Spain
    Ukraine
    United Kingdom
    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 years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days24
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days24
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 150
    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)
    nessuna
    nessuna
    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 Decision2020-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-04
    P. End of Trial
    P.End of Trial StatusOngoing
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