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    Summary
    EudraCT Number:2016-002763-34
    Sponsor's Protocol Code Number:GS-US-419-3896
    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:2021-06-15
    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 number2016-002763-34
    A.3Full title of the trial
    A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn's Disease
    Studio di estensione a lungo termine per la valutazione della sicurezza di Filgotinib in soggetti con morbo di Crohn
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn's Disease
    Studio di estensione a lungo termine per valutare la sicurezza di un nuovo trattamento in soggetti con morbo di Crohn
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberGS-US-419-3896
    A.5.4Other Identifiers
    Name:NANumber:NA
    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 SponsorGILEAD SCIENCES INCORPORATED
    B.1.3.4CountryUnited States
    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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00471223897284
    B.5.5Fax number00441223897284
    B.5.6E-mailclinical.trials@gilead.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 nameFilgotinib
    D.3.2Product code [GS-6034]
    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.3.8INN - Proposed INNFilgotinib
    D.3.9.2Current sponsor codeGS-6034
    D.3.9.4EV Substance CodeSUB182273
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 nameFilgotinib
    D.3.2Product code [GS-6034]
    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.3.8INN - Proposed INNFilgotinib
    D.3.9.2Current sponsor codeGS-6034
    D.3.9.4EV Substance CodeSUB182273
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Moderately to Severely Active Crohn's Disease (CD)
    Morbo di Crohn attivo di grado da moderato a severo
    E.1.1.1Medical condition in easily understood language
    Crohn's Disease
    Morbo di Crohn
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10013099
    E.1.2Term Disease Crohns
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To observe the long-term safety of filgotinib in subjects who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in CD
    Osservare la sicurezza a lungo termine di filgotinib in soggetti che hanno portato a termine uno studio precedente di trattamento con filgotinib per il MC sponsorizzato da Gilead o ne hanno soddisfatto i criteri di interruzione per l'efficacia specificati dal protocollo
    E.2.2Secondary objectives of the trial
    To evaluate the effect of filgotinib on Patient Reported Outcomes (PRO2) and Crohn's Disease Activity Index (CDAI) scores
    Valutare l'effetto di filgotinib sui punteggi degli esiti riferiti dai pazienti (Patient Reported Outcomes, PRO2) e dell'indice di attività del morbo di Crohn (Crohn’s Disease Activity Index, CDAI)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures associated with this trial • Must have met all eligibility criteria from a Gilead-sponsored CD parent
    protocol
    • Females of childbearing potential must have a negative pregnancy test at Day 1 and must agree to continued monthly pregnancy testing during
    use of filgotinib treatment
    • Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
    • Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
    • Devono essere in grado di comprendere e firmare un consenso informato scritto (ICF), che deve essere ottenuto prima dell'inizio delle procedure dello studio associato a questa sperimentazione.
    • Devono essere stati arruolati in uno studio Gilead sponsored con un protocolloper CD, GS-US-419-4015, GS-US-419-4016 o GS-US-419-3895
    • Le donne in età fertile devono presentare un test di gravidanza negativo alla visita del Giorno 1 e devono acconsentire a sottoporsi a test di gravidanza mensili continuativi durante il trattamento con filgotinib.
    • I soggetti di sesso maschile e quelli di sesso femminile in età fertile che hanno rapporti eterosessuali devono acconsentire a utilizzare uno o più metodi contraccettivi specificati dal protocollo, come descritto nell'Appendice 6, per l'intera durata specificata.
    • Disponibilità ad astenersi dall'uso di vaccini vivi o attenuati durante lo studio e per le 12 settimane successive all'ultima dose di farmaco dello studio.
    E.4Principal exclusion criteria
    • Subjects who are discontinued from a parent study for reasons other than disease worsening, or lack of response or remission; eg, subjects who discontinue for safety or tolerability issues are not eligible for the
    present study.
    • Known hypersensitivity to the study drug
    • Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator, would make the subject unsuitable for the study or would prevent compliance with the study protocol
    • Females who may wish to become pregnant and/or plan to undergo egg donation or egg harvesting for the purpose of current or future
    fertilization during the course of the study and for at least 35 days of the last dose of the study drug
    • Male subjects unwilling to refrain from sperm donation for at least 90 days after the last dose of study drug
    • Males or females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the protocol
    • Use of prohibited medications as outlined in the protocol
    • I soggetti che hanno interrotto uno studio originario per motivi diversi dal peggioramento della malattia o dalla mancanza di risposta o di remissione, per es. i soggetti che si ritirano per problemi di sicurezza o di tollerabilità, non sono idonei allo studio.
    • Ipersensibilità nota al farmaco dello studio.
    • Qualsiasi condizione medica cronica (incluse, ma non limitate a, malattia cardiaca o polmonare, abuso di alcool o di farmaci) che, nel parere dello Sperimentatore, renderebbe il soggetto non idoneo allo studio o impedirebbe la conformità al protocollo dello studio.
    • Donne che potrebbero voler iniziare una gravidanza e/o prevedono di donare ovuli o di farsi prelevare ovuli per finalità di fertilizzazione attuale o futura durante lo svolgimento dello studio e per almeno 35 giorni dall'ultima dose di farmaco dello studio.
    • Uomini non disposti ad astenersi dalla donazione di sperma per almeno 90 giorni dall'ultima dose di farmaco dello studio.
    • Uomini o donne in età riproduttiva che non siano disposti a rispettare i metodi contraccettivi specificati nel protocollo e definiti nell'Appendice 6
    • Uso di farmaci non ammessi, come descritto nel protocollo
    E.5 End points
    E.5.1Primary end point(s)
    Safety, evaluated through AEs, clinical laboratory tests, and vital signs
    Le valutazioni sulla sicurezza comprendono la documentazione degli AE, dell'esame fisico (orientato ai sintomi), dei segni vitali e delle analisi cliniche di laboratorio (ematologia, chimica ed esame delle urine).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 432
    Settimana 432
    E.5.2Secondary end point(s)
    Change from baseline in PRO2 and CDAI scores
    L'efficacia sarà valutata in termini di variazioni dei punteggi di PRO2 e del CDAI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 144
    Settimana 144
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    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 Yes
    E.8.1.7.1Other trial design description
    Subject to receive open-label or blinded IMP depending on their disease response in the parent study
    Subject to receive open-label or blinded IMP depending on their disease response in the parent study
    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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA180
    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
    Canada
    Georgia
    Hong Kong
    India
    Israel
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    New Zealand
    Russian Federation
    Serbia
    Singapore
    South Africa
    Taiwan
    Ukraine
    United States
    Austria
    Belgium
    Bulgaria
    Croatia
    France
    Germany
    Greece
    Hungary
    Iceland
    Ireland
    Italy
    Netherlands
    Norway
    Poland
    Portugal
    Romania
    Slovakia
    Spain
    Sweden
    Switzerland
    United Kingdom
    Czechia
    Argentina
    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
    End of study is defined as when teh last subject has completed 432 weeks ( or until filgotinib becomes commercially available, whichever comes first) or treatment plus Post Treatment (PTx) assessment 30 days after the last dose of study drug
    End of study is defined as when teh last subject has completed 432 weeks ( or until filgotinib becomes commercially available, whichever comes first) or treatment plus Post Treatment (PTx) assessment 30 days after the last dose of study drug
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years13
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days28
    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: 920
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 380
    F.4.2.2In the whole clinical trial 1000
    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)
    Post study care is at the discretion of the treating investigator or physician.
    L'assistenza a lungo termine sarà responsabilità del medico curante.
    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 Decision2018-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-26
    P. End of Trial
    P.End of Trial StatusCompleted
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