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    Summary
    EudraCT Number:2016-001367-36
    Sponsor's Protocol Code Number:GS-US-419-3895
    National Competent Authority:Croatia - MIZ
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-09-12
    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 ConcernedCroatia - MIZ
    A.2EudraCT number2016-001367-36
    A.3Full title of the trial
    Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease
    Kombinirana, dvostruko slijepa, randomizirana, placebom kontrolirana ispitivanja faze 3 za procjenu učinkovitosti i sigurnosti filgotiniba u indukciji i održavanju remisije u ispitanika s umjerenom do teško aktivnom Crohnovom bolešću
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease
    A.4.1Sponsor's protocol code numberGS-US-419-3895
    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/ cityCambridge
    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 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.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 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.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)
    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 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
    The primary objectives of Cohort A Induction Study are:
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical remission by Patient Reported Outcomes (PRO2) at Week 10
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing endoscopic response at Week 10

    The primary objectives of Cohort B Induction Study are:
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical remission by PRO2 at Week 10
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing endoscopic response at Week 10

    The primary objectives of the Maintenance Study are:
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical remission by PRO2 at Week 58
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing endoscopic response at Week 58
    E.2.2Secondary objectives of the trial
    Key secondary objectives of both Cohort A Induction Study & Cohort B Induction Study are:
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical remission by Crohn’s Disease Activity Index (CDAI) at Week 10
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing both clinical remission by PRO2 score & endoscopic response at Week 10

    Key secondary objectives of the Maintenance Study are:
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical remission by CDAI at Week 58
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing sustained clinical remission by PRO2 at Weeks 10 & 58
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing both clinical remission by PRO2 & endoscopic response at Week 58
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing 6-month corticosteroid-free remission by PRO2 at Week 58
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic (PK) Substudy
    An optional PK substudy will be performed in a subset of subjects (approximately 30 subjects each in Cohort A and Cohort B) who provide a separate informed consent. In the PK substudy, the daily dose of study drug should be administered under supervision in the clinic (between Week 2 and Week 10 inclusive), and additional PK samples should be collected predose and at 0.5, 1, 2, 3, 4, and 6 hours post dose.
    If a substudy PK sample is scheduled to be collected at the same time as a sparse PK sample, only one sample should be collected.

    Genomic Substudy
    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
    Subjects must meet all of the following inclusion criteria to be eligible for participation in either the Cohort A or B Induction Study.
    • Must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures
    • Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit
    • Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline
    • Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
    • Documented diagnosis of CD with a minimum disease duration of 3 months with involvement of the ileum and/or colon at a minimum
    • Moderately or severely active CD
    • Meet one of the protocol specified tuberculosis (TB) screening criteria
    • May be receiving the following drugs (subjects on these therapies must be willing to remain on stable doses for the times noted in the protocol)
    - Oral 5-aminosalicylate (5-ASA) compounds
    - Azathioprine or 6-mercaptopurine (6-MP) or methotrexate (MTX)
    - Oral corticosteroid therapy
    - Antibiotics for the treatment of CD
    • Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose
    • Must be up to date on colorectal cancer screening and surveillance as standard of care according to local guidelines

    Biologic-Naïve subjects must meet all of the additional inclusion criteria to be eligible for participation in Cohort A
    • Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least one of the following agents (depending on current country treatment recommendations/guidelines):
    - Corticosteroids
    - Immunomodulators

    Biologic-Experienced subjects must meet all of the additional inclusion criteria to be eligible for Cohort A.
    •Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least one of the following agents (depending on current country treatment recommendations/guidelines) or discontinuation of use of at least one of the following agents for reasons other than inadequate clinical response, loss of response, or intolerance:
    -TNFα Antagonists
    -Vedolizumab
    -Ustekinumab
    •Must not 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. or discontinuation of use of at least one of the following agents for reasons other than inadequate clinical response, loss of response, or intolerance:
    T- NFα Antagonists
    - Vedolizumab
    - Ustekinumab

    Subjects must meet all of the additional inclusion criteria to be eligible for participation in Cohort B induction study.
    • Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least one of the following agents (depending on current country treatment recommendations/guidelines):
    - TNFα Antagonists
    - Vedolizumab
    - Ustekinumab
    • Must not 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

    Subjects must meet all of the following inclusion criteria to be eligible for participation in the Maintenance Study.
    • Completion of Cohort A or B induction study with either clinical remission by PRO2 or endoscopic response at Week 10
    • Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose
    • May be on oral corticosteroid therapy (prednisone prescribed at a stable dose ≤ 30 mg/day or budesonide at a dose of ≤ 9 mg/day); dose must remain stable to Week 14
    longer
    E.4Principal exclusion criteria
    Subjects who meet any of the following exclusion criteria are not to be enrolled in either the Cohort A or B induction study
    •Pregnant or lactating females
    •Males and females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods
    •Females who may wish to become pregnant and/or plan to undergo egg donation or egg harvesting
    •Male subjects unwilling to refrain from sperm donation during the study and for at least 90 days after the last dose of study drug
    •Known hypersensitivity to filgotinib its metabolites, or formulation excipients
    •Currently have complications of CD
    •Have any current or prior abscesses
    •History of major surgery or trauma within 30 days prior to screening
    •Presence of UC, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
    •History of total colectomy, subtotal-colectomy, presence of ileostomy or colostomy, or likely requirement for surgery during the study
    •Dependence on parenteral nutrition
    •History or evidence of incompletely resected colonic mucosal dysplasia
    •Stool sample positive for C. diff toxin, pathogenic E. coli, Salmonella species (spp), Shigella spp, Campylobacter spp, or Yersinia spp
    •Stool sample positive for O&P unless approved by the medical monitor
    •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)
    •Infection with HIV, HBV or HCV
    •Presence of Child-Pugh Class C hepatic impairment
    •Active TB or history of latent TB that has not been treated
    •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
    •History of lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorder or multiple myeloma
    •History of treatment with lymphocyte-depleting therapies, including but not limited to alemtuzumab, cyclophosphamide, total lymphoid radiation and rituximab
    •History of cytapheresis ≤ 2 months prior to screening
    •Use of any prohibited concomitant medications
    •Any chronic medical condition or psychiatric problem that, in the opinion of the Investigator or Sponsor, would make the subject unsuitable for the study or would prevent compliance with the study protocol
    •Administration of a live or attenuated vaccine within 30 days of randomization
    •History of opportunistic infection or immunodeficiency syndrome
    •Currently on any chronic systemic anti-infective therapy for chronic infection
    •History of disseminated Staphylococcus aureus
    •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

    Biologic-Naïve subjects who meet any of the following exclusion criteria are not eligible for Cohort A
    •Prior or current use of TNFα antagonist, including (but not limited to) infliximab, adalimumab, golimumab, certolizumab or biosimilar agent
    •Prior or current use of vedolizumab
    •Prior or current use of ustekinumab

    Biologic-Experienced subjects who meet the following exclusion criterion are not eligible for Cohort A
    •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. 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.
    Subjects who meet the following exclusion criterion are not to be enrolled in Cohort B induction study
    •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.
    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.

    Subjects who meet any of the following exclusion criteria are not to be enrolled in the maintenance study
    •Males and females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods
    •Females who may wish to become pregnant &/or plan to undergo egg donation or egg harvesting
    •Male subjects unwilling to refrain from sperm donation during the study & for at least 90 days after the last dose of study drug
    •Use of any prohibited concomitant medications
    E.5 End points
    E.5.1Primary end point(s)
    Cohort A Induction Study
    • The proportion of subjects achieving clinical remission by PRO2 at Week 10
    • The proportion of subjects achieving endoscopic response at Week 10

    Cohort B Induction Study
    • The proportion of subjects achieving clinical remission by PRO2 at Week 10
    • The proportion of subjects achieving endoscopic response at Week 10

    Maintenance Study
    • The proportion of subjects achieving clinical remission by PRO2 at Week 58
    • The proportion of subjects achieving endoscopic response at Week 58
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 10 and Week 58
    E.5.2Secondary end point(s)
    Cohort A Induction Study
    The key secondary endpoints are:
    • The proportion of subjects achieving clinical remission by CDAI at Week 10
    • The proportion of subjects achieving both clinical remission by PRO2 and endoscopic response (combined into a single endpoint on a patient level) at Week 10

    Cohort B Induction Study
    The key secondary endpoints are:
    • The proportion of subjects achieving clinical remission by CDAI at Week 10
    • The proportion of subjects achieving both clinical remission by PRO2 and endoscopic response (combined into a single endpoint on a patient level) at Week 10

    Maintenance Study
    The key secondary endpoints are:
    • The proportion of subjects achieving clinical remission by CDAI at Week 58
    • The proportion of subjects achieving sustained clinical remission by PRO2 at Weeks 10 and 58
    • The proportion of subjects achieving both clinical remission by PRO2 and endoscopic response (combined into a single endpoint on a patient level) at Week 58
    • The proportion of subjects achieving 6 month corticosteroid-free remission by PRO2 at Week 58
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 10 and Week 58
    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 Yes
    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) 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 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 Yes
    E.8.1.7.1Other trial design description
    Combined induction and maintenance phase study design
    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 EEA200
    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
    Argentina
    Australia
    Austria
    Belarus
    Belgium
    Brazil
    Bulgaria
    Canada
    Croatia
    Czech Republic
    France
    Georgia
    Germany
    Greece
    Hong Kong
    Hungary
    Iceland
    India
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    Netherlands
    New Zealand
    Norway
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Singapore
    Slovakia
    South Africa
    Spain
    Sri Lanka
    Sweden
    Switzerland
    Taiwan
    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 58 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 years4
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days27
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days30
    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: 1214
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 106
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 510
    F.4.2.2In the whole clinical trial 1320
    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 all study related procedures, including endoscopy at Week 58, will be offered an 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 Decision2017-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-26
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
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