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    Summary
    EudraCT Number:2016-003179-23
    Sponsor's Protocol Code Number:GS-US-419-4015
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-06
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2016-003179-23
    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 Small Bowel Crohn’s Disease (SBCD)
    II. fázisú, kettős vak, randomizált, placebo kontrollált vizsgálat a filgotinib
    hatásosságának és biztonságosságának értékelésére, a vékonybelet érintő
    Crohn-betegség (SBCD) kezelésében
    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 small bowel Crohn’s disease.
    A.4.1Sponsor's protocol code numberGS-US-419-4015
    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
    Small Bowel Crohn’s Disease
    Vékonybelet érintő Crohn betegség
    E.1.1.1Medical condition in easily understood language
    Crohn's disease
    Crohn betegség
    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 PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal 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 study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission at Week 24
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    - To evaluate the impact of filgotinib, when compared to placebo, on change in segmental MaRIA score for all small bowel segments at Week 24
    - To evaluate the efficacy of filgotinib, when compared to placebo, in establishing small bowel MaRIA remission at Week 24
    - To evaluate the efficacy of filgotinib, when compared to placebo, in establishing MaRIA remission in the terminal ileum at Week 24
    - To evaluate the efficacy of filgotinib, when compared to placebo, in establishing global MaRIA remission at Week 24
    - To evaluate the efficacy of filgotinib, when compared to placebo, in improving symptoms of abdominal pain and liquid stool frequency as measured by change in PRO2 at Weeks 10 and 24
    - 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) Moderately or severely active CD as defined by screening CDAI 200 to 450 (inclusive).
    6) Minimum duration of CD of at least 6 months
    7) Presence of diseased SB segments on MRE with segmental MaRIA score of ≥ 7 in at least 1 of the following segments: terminal ileum, distal ileum, or jejunum.
    8) Patients with additional colonic involvement of CD are permitted in study as long as SBCD is present.
    9) Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines):
    a) Corticosteroids
    b) Immunomodulators
    c) TNFα Antagonists
    d) Vedolizumab
    e)Ustekinumab
    10) Meet one of the following tuberculosis (TB) screening criteria:
    a) No evidence of active or latent TB
    b) Previously treated for TB
    c) Newly identified latent TB during screening
    11) Laboratory parameters within specified intervals
    12) May be receiving the following drugs (subjects on these therapies must be willing to
    remain on stable doses for the noted times):
    a) Oral 5-aminosalicylate (5-ASA) compounds
    b) Oral corticosteroid therapy
    c) Azathioprine or 6-MP or methotrexate
    d) Antibiotics for the treatment of CD
    13) Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug.
    14) Willing and able to undergo MRE per protocol requirements
    15) Must be up to date on colorectal cancer screening and surveillance
    as standard of care according to 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) Presence of symptomatic or clinically significant (eg, obstructive or symptomatic) strictures
    or stenosis.
    7) Presence of fistulae.
    8) Evidence of short bowel syndrome.
    9) Any other complication of CD that could preclude the use of CDAI to assess response to
    therapy or would confound the evaluation of benefit from treatment with filgotinib.
    10) Claustrophobia to a degree that prevents tolerance of MRE scanning procedure (sedation is permitted at discretion of investigator).
    11) Metallic implant of any sort that prevents MRE 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 MRE examination.
    12) Known hypersensitivity to gadolinium
    13) Isolated colonic CD, or isolated CD that does not involve some segment of the small bowel.
    14) Evidence of any other CD manifestation that might require imminent surgery or would
    possibly confound the evaluation of benefit from treatment with filgotinib.
    15) Have any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to Day 1 and are not anticipated to require surgery.
    16) History of major surgery or trauma within 30 days prior to screening.
    17) Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon.
    18) Dependence on parenteral nutrition.
    19) History of total colectomy, subtotal, hemi-colectomy, presence of ileostomy or colostomy, or likely requirement for surgery during the study.
    20) History or evidence of incompletely resected colonic mucosal dysplasia.
    21) Stool sample positive for Clostridium difficile (C. diff) toxin, pathogenic Escherichia coli (E. coli), Salmonella species (spp), Shigella spp, Campylobacter spp, or Yersinia spp.
    22) Stool sample positive for ova or parasites test (O&P) unless approved by the Medical Monitor
    23) Have used any TNFα antagonist or vedolizumab ≤ 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.
    24) Use of any prohibited concomitant medication
    25) History of leukocytapharesis ≤ 6 months prior to screening.
    26) 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 requiring oral anti-infective therapy within 2 weeks of screening (or 6 weeks of Day 1).
    27) Co-Infection with human immunodeficiency virus (HIV), HBV, or HCV.
    28) Presence of Child-Pugh Class C hepatic impairment
    29) 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 study protocol.
    30) 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.
    31) History of opportunistic infection or immunodeficiency syndrome.
    32) Active TB or history of latent TB that has not been treated (see Inclusion Criterion 10 for more details).
    33) History of lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorder, or multiple myeloma.
    34) History of treatment with lymphocyte depleting therapies, including but not limited to alemtuzumab, cyclophosphamide, total lymphoid irradiation, and rituximab.
    35) Administration of live or attenuated vaccine within 30 days of randomization.
    36) Currently on any chronic systemic (oral or intravenous) anti-infective therapy for chronic infection (such as pneumocystis, CMV, herpes zoster, atypical mycobacteria).
    37) History of disseminated Staphylococcus aureus.
    38) History of symptomatic herpes zoster or herpes simplex
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects achieving clinical remission by CDAI < 150 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:
    - Change from baseline in segmental MaRIA score for all small bowel segments at Week 24
    - Proportion of subjects achieving small bowel MaRIA remission at Week 24
    - Proportion of subjects achieving MaRIA remission in the terminal ileum at Week 24 for subjects with active in the terminal ileum at baseline
    - Proportion of subjects achieving global MaRIA remission at Week 24
    - Change from baseline in score of abdominal pain and liquid stool frequency as measured by PRO2 at Weeks 10 and 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    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 EEA50
    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
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Italy
    Poland
    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
    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 months1
    E.8.9.1In the Member State concerned days20
    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 days20
    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: 92
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 100
    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 Decision2017-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-20
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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