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    Summary
    EudraCT Number:2016-001392-78
    Sponsor's Protocol Code Number:GS-US-418-3898
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-12-06
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-001392-78
    A.3Full title of the trial
    Combined Phase 2b/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 Ulcerative Colitis
    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 Ulcerative Colitis
    A.4.1Sponsor's protocol code numberGS-US-418-3898
    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+44 1223 897284
    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 Ulcerative Colitis (UC)
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    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 Cohort A Induction Study is:
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing endoscopy/bleeding/stool (EBS) remission at Week 10

    The primary objective of Cohort B Induction Study is:
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing EBS remission at Week 10

    The primary objective of the Maintenance Study is:
    • To evaluate the efficacy of filgotinib as compared to placebo in establishing EBS remission at Week 58
    E.2.2Secondary objectives of the trial
    The key secondary objectives of both Cohort A and Cohort B Induction Study are to evaluate the efficacy of filgotinib as compared to placebo in establishing:
    • Mayo Clinic Score (MCS) remission at Week 10
    • An endoscopic subscore of 0 at Week 10
    • Geboes histologic remission at Week 10
    • MCS remission (alternative definition) at Week 10

    The key secondary objectives of the Maintenance Study are to evaluate the efficacy of filgotinib as compared to placebo in establishing:
    • MCS remission at Week 58
    • Sustained EBS remission at Week 58, defined as EBS remission at both Weeks 10 and 58
    • 6-month corticosteroid-free EBS remission at Week 58
    • An endoscopic subscore of 0 at Week 58
    • Geboes histologic remission at Week 58
    • MCS remission (alternative definition) 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 consent. In the PK substudy, the daily dose of study drug should be administered under supervision in the clinic (at one visit 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 sub-study 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 informed consent form, 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 pregnancy test at screening and 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 UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge.
    • A surveillance colonoscopy is required prior to screening in subjects with a history of UC for 8 or more years, if one was not performed in the prior 24 months
    • Moderately to severely active UC
    • Meet one of the protocol specified tuberculosis (TB) screening criteria
    • Laboratory parameters (subjects who fail to meet the protocol specified reference laboratory tests may be re-tested once at discretion of investigator prior to being considered a screen failure)
    • May be receiving the following drugs (subjects on these therapies should be willing to remain on stable doses for the times specified in the protocol):
    - Oral 5-aminosalicylate (5-ASA) compounds
    - Azathioprine, 6-mercaptopurine (6-MP) or methotrexate (MTX)
    - Oral corticosteroid therapy
    • Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose

    Subjects must meet all of the additional following inclusion criteria to be eligible for participation in Cohort A Induction Study:
    • 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):
    - Corticosteroids
    - Immunomodulators

    Subjects must meet all the additional following inclusion criteria to be eligible for participation in Cohort B Induction Study:
    • Previously demonstrated an inadequate clinical response, loss of response to, or intolerance of at least one of the following agents (depending on current country treatment recommendations/guidelines):
    - Tumor necrosis factor-alpha (TNFα) Antagonists
    - Vedolizumab
    • Must not have used any TNFα antagonist or vedolizumab ≤ 8 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 MCS response or EBS remission based on Week 10 assessments
    • 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
    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 for the purpose of current or future fertilization during the course of the study and up to 35 days after last dose of the study drug
    • Male subjects unwilling to refrain from sperm donation for at least 90 days after last dose of the study drug
    • Known hypersensitivity to filgotinib, its metabolites, or formulation excipients
    • Exhibit acute severe UC as defined in the protocol
    • Use of rectal formulations of 5-aminosalicylate (5-ASA) compounds or rectal corticosteroids 2 weeks prior to screening
    • History of major surgery or trauma within 30 days prior to screening
    • Presence of Crohn’s diease (CD), indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon
    • Prior surgical intervention for UC (eg, total colectomy, subtotal colectomy, partial or hemicolectomy, 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 Clostridium difficile (C. diff) toxin, pathogenic Escherichia coli (E. coli), Salmonella species (spp), Shigella spp, Campylobacter spp or Yersinia spp
    • Stool sample positive for ova and parasites test (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, hepatitis B or hepatitis C
    • Presence of Child-Pugh Class C hepatic impairment
    • Active TB or history of latent TB that has not been treated
    • History of malignancy in the last 5 years except for subjects who have been successfully treated 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 alemtuzab, cyclophosphamide, total lymphoid radiation, and rituximab
    • History of cytapherisis ≤ 2 months prior to screening
    • Use of prohibited concomitant medications as described in the protocol
    • Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, or substance abuse) 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 procedures
    • Administration of a live or attenuated vaccine within 30 days of randomization
    • History of opportunistic infection or immunodeficiency syndrome
    • Currently on any chronic systemic (oral or intravenous) anti-infective therapy for chronic infection (such as pneumocystis (PCP), cytomegalovirus (CMV), herpes zoster, atypical mycobacteria)
    • 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

    Subjects who meet any of the following exclusion criteria are not to be enrolled in Cohort A Induction Study.
    • Prior use of any TNFα antagonist including (but not limited to) infliximab, adalimumab, golimumab, certolizumab, or biosimilar agents at any time
    • Prior or current use of vedolizumab at any time

    Subjects who meet the following exclusion criterion are not eligible to be enrolled in Cohort B Induction Study:
    • Have used any TNFα antagonist or vedolizumab within ≤ 8 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 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 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 last dose of the study drug
    • Male subjects unwilling to refrain from sperm donation during the study and for at least 90 days after last dose of the study drug
    • Use of prohibited concomitant medications as described in the protocol
    E.5 End points
    E.5.1Primary end point(s)
    Cohort A Induction Study
    • The proportion of subjects achieving EBS remission at Week 10

    Cohort B Induction Study
    • The proportion of subjects achieving EBS remission at Week 10

    Maintenance Study
    • The proportion of subjects achieving EBS remission 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 proportion of subjects achieving MCS remission at Week 10
    • The proportion of subjects achieving endoscopic subscore of 0 at Week 10
    • The proportion of subjects achieving Geboes histologic remission at Week 10
    • The proportion of subjects achieving MCS remission (alternative definition) at Week 10

    Cohort B Induction Study
    • The proportion of subjects achieving MCS remission at Week 10
    • The proportion of subjects achieving endoscopic subscore of 0 at Week 10
    • The proportion of subjects achieving Geboes histologic remission at Week 10
    • The proportion of subjects achieving MCS remission (alternative definition) at Week 10

    Maintenance Study
    • The proportion of subjects achieving MCS remission at Week 58
    • The proportion of subjects achieving sustained EBS remission, defined as establishing EBS remission at both Weeks 10 and 58
    • The proportion of subjects achieving 6-month corticosteroid-free EBS remission at Week 58
    • The proportion of subjects achieving endoscopic subscore of 0 at Week 58
    • The proportion of subjects achieving Geboes histologic remission at Week 58
    • The proportion of subjects achieving MCS remission (alternative definition) 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) Yes
    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 concerned13
    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
    Belgium
    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
    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 years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days29
    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: 1196
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 104
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 590
    F.4.2.2In the whole clinical trial 1300
    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 long-term extension (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 Decision2016-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-03-31
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