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    Summary
    EudraCT Number:2017-001485-17
    Sponsor's Protocol Code Number:GS-US-432-4097
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-06-21
    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 number2017-001485-17
    A.3Full title of the trial
    A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects with Active Non-Infectious Uveitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 trial assessing the effectiveness (efficacy) and safety of Filgotinib compared to placebo in subjects with active non-infectious Uveitis
    A.4.1Sponsor's protocol code numberGS-US-432-4097
    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 Trial 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.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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-infectious Uveitis
    E.1.1.1Medical condition in easily understood language
    Non-infectious Uveitis
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10022557
    E.1.2Term Intermediate uveitis
    E.1.2System Organ Class 100000004853
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10036370
    E.1.2Term Posterior uveitis
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10033687
    E.1.2Term Panuveitis
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of filgotinib versus placebo for the treatment of the signs and symptoms of non-infectious uveitis as measured by the proportion of subjects failing treatment for active non-infectious uveitis by Week 24
    E.2.2Secondary objectives of the trial
    - Evaluate the efficacy of filgotinib versus placebo as measured by the time to treatment failure
    - Evaluate the efficacy of filgotinib versus placebo as measured by the change in VH grade in each eye (NEI/SUN criteria)
    - Evaluate the efficacy of filgotinib versus placebo as measured by the change in AC cell grade in each eye
    - Evaluate the efficacy of filgotinib versus placebo as measured by the change in logMAR BCVA in each eye
    - Evaluate the efficacy of filgotinib versus placebo as measured by the change in central retinal thickness in each eye
    - Evaluate the efficacy of filgotinib versus placebo as measured by the time to development of macular edema in at least one eye as determined by OCT
    - Evaluate the safety and tolerability of filgotinib
    - Evaluate the pharmacokinetics of filgotinib and its metabolite GS-829845
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Judged to be in good health as determined by the investigator based on the results of medical history, laboratory screening profile, physical examination, chest x-ray, and 12-lead electrocardiogram performed during Screening
    - A negative serum pregnancy test is required for female subjects of childbearing potential
    - Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
    - Lactating females must agree to discontinue nursing before the study drug is administered
    - Male or female subjects who are ≥ 18 years of age on the day of signing informed consent
    - Diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis
    - Active uveitic disease at the Day 1/Baseline visit as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of maintenance therapy with oral prednisone (≥ 10 mg/day to ≤ 60 mg/day) or an oral corticosteroid equivalent
    - On oral prednisone ≥ 10 mg/day to ≤ 60 mg/day (or oral corticosteroid equivalent) for 2 or more weeks immediately prior to and including Day 1/Baseline
    - Documented prior adequate response to oral corticosteroids (equivalent of oral prednisone up to 1 mg/kg/day)
    - No evidence of active tuberculosis (TB), previously treated for TB or newly identified latent TB during screening
    - Able and willing to sign the informed consent as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB). Written consent must be provided before initiating any screening evaluations. Subjects must have read and understood the ICF, must fully understand the requirements of the study, and must be willing to comply with all study visits and assessments. Subjects who cannot understand the ICF may not be enrolled by a guardian or any other individual.
    E.4Principal exclusion criteria
    - The presence of isolated anterior uveitis
    - The presence of macular edema as the only sign of intermediate-, posterior- or pan-uveitis
    - Intolerance to or prior inadequate response to high-dose oral corticosteroids (equivalent of oral prednisone 1 mg/kg/day or 60 to 80
    mg/day)
    - Confirmed or suspected infectious uveitis
    - Presumed ocular histoplasmosis syndrome (as determined by the investigator)
    - Ocular masquerade syndromes such as ocular lymphoma (as determined by the investigator)
    - Serpiginous choroidopathy
    - Corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial
    - Subject with elevated intraocular pressure and/or Severe glaucoma who is unable to meet one or more of the protocol defined criteria within the screening period
    - Exposure to a systemic carbonic anhydrase inhibitor within 1 week prior to Screening
    - Best Corrected Visual Acuity (BCVA) less than 20 letters (Early Treatment Diabetic Retinopathy Study) in any eye at the Day 1/Baseline
    Visit
    - Previous exposure to an approved or experimental JAK inhibitor therapy
    - Any condition preventing the evaluation/assessment of both eyes for eligibility criteria and/or for the presence of treatment failure criteria, as detailed in the protocol
    - Exposure to anti-tumor necrosis factor (TNF) therapy or any biologic therapy within 4 weeks of Day 1/Baseline (as per the protocol).
    - Received intravitreal anti-VEGF therapy within 45 days of the Day 1/Baseline visit [i.e Lucentis® (ranibizumab) or Avastin® (bevacizumab)] or within 60 days of the Day 1/Baseline visit for anti-VEGF Trap (i.e, aflibercept)
    - Use of more than 1 accepted immunosuppressive therapy (not counting corticosteroids) at Day 1/Baseline
    - Using concomitant immunosuppressive therapy at Day 1/Baseline other than methotrexate or azathioprine
    - If entering the study on 1 concomitant immunosuppressive therapy, dose has been increased within 28 days prior to Day 1/Baseline visit or is not within the allowable doses defined in the protocol
    - Systemic inflammatory disease requiring continued therapy with oral corticosteroids or a prohibited immunosuppressive agent at screening or Day 1/Baseline
    - Received Retisert® (glucocorticosteroid implant) within 3 years prior to the Day 1/Baseline visit or has had complications related to the
    device
    - Received intraocular or periocular corticosteroids within 30 days prior to Day 1/Baseline visit
    - Presence of proliferative or severe non-proliferative diabetic retinopathy or clinically significant macular edema due to diabetic retinopathy
    - Presence of neovascular/wet age-related macular degeneration
    - Presence of a clinically significant abnormality of vitreo-retinal interface per investigator discretion (i.e., vitreomacular traction,
    epiretinal membranes, etc.) with the potential for macular structural damage independent of the inflammatory process
    - Presence of severe vitreous haze that precludes visualization of the fundus at the Day 1/Baseline visit
    - Received Ozurdex® (dexamethasone implant) within 3 months prior to the Day 1/Baseline visit
    - Received intravitreal methotrexate within 90 days prior to the Day 1/Baseline visit
    - Use of cyclophosphamide within 30 days prior to the Day 1/Baseline visit
    - Evidence of any clinically significant (as per the judgement of the investigator) active or chronic recurring infection, opportunistic
    infection, or immunodeficiency syndrome
    - Severe (anaphylactic) reactions to fluorescein or unwillingness to perform fluorescein angiograms
    - Known hypersensitivity to filgotinib, its metabolites, or formulation excipients
    - Contraindication to pupil dilation with mydriatic eye drops
    - History of prior ocular surgery (excluding eyelid surgery) within 90 days before Day 1/Baseline with the exception of refractive laser
    surgery, retinal laser photocoagulation, or neodymium-doped yttrium aluminium garnet posterior capsulotomy. These 3 exceptions are
    exclusionary within 30 days before Day 1/Baseline
    - Planned (elective) eye surgery (excluding eyelid surgery) within 52 weeks after Day 1/Baseline
    - Participation in any clinical study of an investigational drug/device within 4 weeks or 5 half-lives (whichever is longer) of the drug prior to
    Day 1/Baseline. Exposure to investigational biologics should be discussed with sponsor
    discussed with the sponsor
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects failing treatment for active non-infectious uveitis
    E.5.1.1Timepoint(s) of evaluation of this end point
    By week 24
    E.5.2Secondary end point(s)
    The secondary endpoints of this study are:
    1. Time to treatment failure
    2. Change in VH grade in each eye (NEI/SUN criteria)
    3. Change in AC cell grade in each eye
    4. Change in logMAR BCVA in each eye
    5. Log change in central retinal thickness in each eye
    6. Time to development of macular edema in at least one eye as determined by OCT
    7. Pharmacokinetic characteristics for filgotinib and its metabolite GS-829845
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. On or after Week 6
    2. Up to Week 52/End of Treatment visit or Early Termination visit
    3. Up to Week 52/End of Treatment visit or Early Termination visit
    4. Up to Week 52/End of Treatment visit or Early Termination visit
    5. Up to Week 52/End of Treatment visit or Early Termination visit
    6. On or after Week 6
    7. From baseline to Week 52/End of Treatment visit or Early Termination visit
    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 No
    E.6.10Pharmacogenetic Yes
    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 Yes
    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 trial2
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Australia
    Canada
    India
    Israel
    Japan
    New Zealand
    United States
    Germany
    Spain
    United Kingdom
    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 52 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 years6
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months4
    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: 223
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 248
    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)
    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 Decision2017-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-15
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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