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    Summary
    EudraCT Number:2016-003153-15
    Sponsor's Protocol Code Number:GS-US-419-4016
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-06
    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 ConcernedAustria - BASG
    A.2EudraCT number2016-003153-15
    A.3Full title of the trial
    A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease.
    A.4.1Sponsor's protocol code numberGS-US-419-4016
    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, Inc.
    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/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.5Fax number+441223897284
    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.3.9.3Other descriptive nameFILGOTINIB
    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 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.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.3.9.3Other descriptive nameFILGOTINIB
    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 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
    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
    Perianal Fistulizing Crohn’s Disease
    E.1.1.1Medical condition in easily understood language
    Crohn's disease
    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 10075465
    E.1.2Term Fistulizing Crohn's disease
    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
    The primary objective of this study is to evaluate the efficacy of filgotinib as compared to placebo in establishing combined fistula response at Week 24
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    - To evaluate the efficacy of filgotinib as compared to placebo in establishing combined fistula remission at Week 24
    - To assess the time to clinical fistula response
    - To assess the time to clinical fistula remission
    -To evaluate the efficacy of filgotinib as compared to placebo in establishing proctitis remission at Week 24, in subjects that had moderately to severely active proctitis at baseline
    - To evaluate the safety and tolerability of filgotinib
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    An optional genomic substudy will be performed in all subjects who agree to participate and provide their additional specific consent. The genomic sample should be collected at the Day 1 visit, but may be collected at any time during the study.
    E.3Principal inclusion criteria
    For a complete list of study inclusion criteria, please refer to study protocol (sections 4.2):
    1) Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
    2) Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of screening visit
    3) Females of childbearing potential must have a negative pregnancy test at screening and baseline
    4) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
    5) Documented diagnosis of Crohn’s disease with a minimum disease duration of 3 months documented by the following as described in the protocol (section 4.2)
    6) At screening, has a minimum of 1 (maximum of 3) draining perianal
    fistulae external openings of ≥ 4 weeks duration as a complication of CD, confirmed by MRI.
    At least 1 (maximum of 3) of the draining perianal fistulae external
    openings present at screening must still be draining at the time of
    randomization.
    Subjects with other fistula types (enterocutaneous, abdominal) in
    addition to the required minimum number of perianal fistula may be
    permitted on discussion with and approval by the Sponsor's Medical
    Monitor.
    7) May have concurrent noncutting perianal seton(s) at screening, which should be removed by the time of randomization
    8) Previously demonstrated an inadequate clinical response, loss of response to, or intolerance of at least 1 of the following agents (depending on current country treatment recommendations/guidelines) as described in the protocol (section 4.2)
    9) Is willing and able to undergo MRI per protocol requirements
    10) Is willing and able to undergo flexible sigmoidoscopy per protocol requirements
    11) Meet one of the following tuberculosis (TB) screening criteria as described in the protocol (section 4.2)
    12) Laboratory parameters (subjects who fail to meet the parameters of any of the below reference laboratory tests may be retested once at
    discretion of investigator prior to being considered a screen failure) as described in the protocol (section 4.2)
    13) May be receiving the following drugs (subjects on these therapies should be willing to remain on stable doses for the noted times) as described in the protocol (section 4.2)
    14) Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
    15) Must be up to date on colorectal cancer screening and surveillance as standard of care according to the local guidelines
    E.4Principal exclusion criteria
    For a complete list of study exclusion criteria, please refer to study protocol (Sections 4.3):
    1) Pregnant or lactating females.
    2) Males and females of reproductive potential who are unwilling to adhere to contraceptive guidance
    3) 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 up to 35 days after the last dose of the study drug.
    4) Male subjects unwilling to refrain from sperm donation during the study and for at least 90 days after the last dose of study drug.
    5) Known hypersensitivity to filgotinib its metabolites, or formulation excipients
    6) Claustrophobia to a degree that prevents tolerance of MRI scanning procedure (sedation is permitted at discretion of investigator).
    7) Metallic implant of any sort that prevents MRI examination, not limited to but including aneurysm clips, metallic foreign body, vascular grafts or cardiac implants, neural stimulator, metallic contraceptive device, body piercing that cannot be removed, cochlear implant; or other contraindication to MRI examination.
    8) Known hypersensitivity to gadolinium
    9) Currently have complications of CD as any of the following as described in protocol section 4.3.
    10) Presence of current rectovaginal, anovaginal, or enterovesicular
    fistulae
    11) Has an abscess > 2 cm or an abscess that the Investigator feels
    requires drainage based on either clinical assessment or MRI, unless
    drained and treated at least 4 weeks prior to Day 1, and are not
    anticipated to require surgery during the study
    12) Has a CDAI score > 400
    13) History of major surgery or trauma within 30 days prior to screening
    14) Presence of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, fulminant colitis,
    or toxic mega-colon
    15) History of total colectomy, hemi-colectomy, presence of ileostomy or colostomy, or likely requirement for surgery during the study
    16) Dependence on parenteral nutrition
    17) History or evidence of incompletely resected colonic mucosal dysplasia
    18) Infection with human immunodeficiency virus (HIV), HBV or HCV
    19) Presence of Child-Pugh Class C hepatic impairment
    20) Stool samples positive for pathogenic Clostridium difficile (C. difficile) toxin, pathogenic Escherichia coli (E. coli), Salmonella species (spp), Shigella spp, Campylobacter spp, or Yersinia spp.
    21) Stool sample positive for ova and parasites test (O&P) unless approved by the medical monitor
    22) Use of any prohibited concomitant medications as described in Section 5.4.2
    23) Has used any TNFα antagonist ≤ 8 weeks prior to screening, ustekinumab IV or SC ≤12 weeks prior to screening, or any other biologic agent ≤ 8 weeks prior to screening or within 5 times the half-life
    of the biologic agent prior to screening, whichever is longer. Subjects
    who have an undetectable serum level of a biologic agent since its last
    dose using a commercially available assay can undergo study screening
    without the above-mentioned waiting period.
    24) Active clinically significant infection or any infection requiring hospitalization or treatment with intravenous anti-infectives within 30 days of screening (or 8 weeks of Day 1); or any infection other than related to the fistula(s) requiring oral anti-infective therapy within 2 weeks of screening (or 6 weeks of Day 1)
    25) Active TB or history of latent TB that has not been treated (see inclusion criterion 11 for further information)
    26) History of opportunistic infection or immunodeficiency syndrome
    27) History of disseminated Staphylococcus aureus
    28) History of symptomatic herpes zoster or herpes simplex within 12 weeks of screening, or any history of disseminated herpes simplex, disseminated herpes zoster, ophthalmic zoster, or central nervous system zoster
    29) Administration of live or attenuated vaccine within 30 days of randomization
    30) Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease)or psychiatric problem (including, but not limited to 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
    31) History of malignancy within the last 5 years except for subjects who have been treated or resected for non-melanoma skin cancer or cervical carcinoma in situ
    32) History of lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorder, or multiple myeloma
    33) History of treatment with lymphocyte-depleting therapies, including but not limited to alemtuzumab, cyclophosphamide, total lymphoid irradiation, and rituximab
    34) History of leukocytapheresis ≤ 6 months prior to Screening
    35) Prior exposure to any Janus kinase (JAK) inhibitor (including but not
    limited to tofacitinib, baricitinib, and upadacitinib)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of subjects establishing combined fistula response at Week 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are:
    - Proportion of subjects establishing combined fistula remission at Week 24
    - Time to clinical fistula response
    - Time to clinical fistula remission
    - Proportion of subjects achieving proctitis remission at Week 24, in subjects that had moderately to severely active proctitis at baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24 for the proportion of subjects establishing combined fistula remission
    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 Yes
    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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Austria
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Italy
    Poland
    Spain
    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
    End of Study is defined as when the last subject has completed 24 weeks of treatment plus 30 days follow-up.
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days19
    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: 69
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 75
    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)
    All subjects completing 24 weeks of treatment will be given the opportunity to participate in the LTE study. For those subjects who do not participate in the LTE study, after the subject has completed their study participation, the long-term care of the participant will remain the responsibility of their primary treating physicians.
    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 Decision2018-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-17
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