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    Summary
    EudraCT Number:2017-000402-38
    Sponsor's Protocol Code Number:GS-US-418-4279
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-11-13
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2017-000402-38
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease
    A.4.1Sponsor's protocol code numberGS-US-418-4279
    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.3.2Product 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.3.9.2Current sponsor codeGS-6034
    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
    To evaluate the testicular safety of filgotinib in adult males with
    moderately to severely Active Inflammatory Bowel Disease
    E.1.1.1Medical condition in easily understood language
    Inflammatory Bowel 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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    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
    To evaluate the effect of filgotinib on testicular function as defined by the proportion of subjects with a ≥ 50% decrease from baseline in sperm concentration at Week 13
    E.2.2Secondary objectives of the trial
    To evaluate the effect of filgotinib on testicular function as defined by the proportion of subjects with a ≥ 50% decrease from baseline in sperm concentration at Week 26
    To evaluate the effect of filgotinib on sperm total motility at Weeks 13 and 26
    To evaluate the effect of filgotinib on total sperm count at Weeks 13 and 26
    To evaluate the effect of filgotinib on the change from baseline in sperm concentration at Weeks 13 and 26
    To evaluate the effect of filgotinib on ejaculate volume at Weeks 13 and 26
    To evaluate the effect of filgotinib on sperm morphology at Weeks 13 and 26
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For a full list please see the study protocol.
    - Males between the age of 21 and 65 (inclusive) on the day of signing informed consent
    - Documented diagnosis of UC or CD of at least 4 months duration. Documentation must include endoscopic and histopathologic documentation, as follows:
    a) UC
    i) Medical record documentation of, or an endoscopy report dated ≥ 4 months before randomization, which shows features consistent with UC, determined by the procedure performing physician, AND
    ii) Medical record documentation of, or a histopathology report indicating features consistent with UC as determined by the pathologist,
    AND
    Note: Subject also needs to have minimum disease extent of 15 cm from the anal verge
    b) CD
    i) Medical record documentation of, or an ileocolonoscopy (full colonoscopy with intubation of terminal ileum) reported dated ≥ 4 months before randomization, which shows features consistent with CD, determined by the procedure performing physician, AND
    ii) Medical record documentation of, or a histopathology report indicating features consistent with, CD as determined by the pathologist

    - Moderately to severely active UC, or moderately to severely active CD, assessed locally and defined by:
    a) UC
    I) Mayo Clinic Score (MCS; Appendix 3) ≥ 6, PGA of 2 or 3, and endoscopic subscore ≥ 2, at Screening or in the prior 90 days
    b) CD
    I) CDAI total score (Appendix 9) ≥ 220, AND
    ii) Evidence of active inflammation, with a total score of ≥ 6 by the Simple Endoscopic Activity Score in Crohn's Disease (SES-CD; Appendix
    10), OR if disease is limited to the ileum and/or right colon, a combined SES-CD score ≥ 4 in these 2 segments, at Screening or in the prior 90 days

    - 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):
    a) corticosteroids
    b) immunomodulators
    c) TNFα antagonists
    d) vedolizumab
    e) Ustekinumab (criterion applicable only to subjects with CD)

    - May be receiving 1 or more of the following drugs (subjects on these therapies must be willing to remain on stable doses for the noted times):
    a) 5-aminosalicylate (5-ASA) compounds provided the dose prescribed has been stable for at least 4 weeks prior to randomization; dose must remain stable for the first 13 weeks after randomization
    b) Azathioprine, 6-MP, or MTX provided the dose prescribed has been stable for 4 weeks prior to randomization; dose of MTX must remain stable for 26 weeks and dose of AZA/6-MP must remain stable for first 13 weeks but can be adjusted if indicated between 13 and 26 weeks.
    c) Corticosteroid therapy (prednisone prescribed at a stable dose ≤ 20 mg/day or budesonide prescribed at a stable dose of ≤ 9 mg/day); dose should not be changed during the first 13 weeks. A steroid taper should only commence after Week 13.

    - The mean of 2 separate semen samples collected at the Screening visit must meet the following minimum criteria (in accordance with Section 6.13 and Figure 6-1): semen volume ≥ 1.5 mL, total sperm per ejaculate ≥ 39 million, sperm concentration ≥ 15 million per mL, sperm total motility ≥ 40%, and normal sperm morphology ≥ 30%.

    LH, FSH, inhibin B, and total testosterone values within 20% of laboratory normal reference ranges at Screening

    - Be up to date on colorectal cancer surveillance as per local guidelines
    prior to screening.
    E.4Principal exclusion criteria
    For a full list please see the study protocol.

    - Previously documented problems with male reproductive health including (but not limited to) known hypothalamic-pituitary disorders (eg, pituitary macroadenomas, pituitary infarction, hyperprolactinemia, panhypopituitarism), primary hypogonadism (eg, cryptorchidism, Klinefelter’s syndrome)

    - Prior diagnosis of male infertility (including reduced fertility), or history of anti-sperm antibodies

    - Clinically significant (per judgment of investigator) varicocele or spermatocele

    - History of radiation to the testicles

    - History of clinically significant trauma to, or surgery on, the testicles, including vasectomy

    - Current treatment with antiandrogen therapy (including but not limited
    to spironolactone or oral ketoconazole), or treatment within 4 weeks of
    Screening

    - Current treatment with testosterone replacement therapy, or treatment within 12 weeks of Screening

    - Presence of disorders of sperm transport (including but not limited to retrograde ejaculation and immotile cilia syndrome)

    - Clinically significant urinary tract infection, prostatitis, epididymitis, including sexually transmitted infection within 4 weeks of Screening

    - Current use of sulfasalazine or use of sulfasalazine within 26 weeks of Screening; sulfasalazine is not permitted at any point during the study

    - Use of any TNFα antagonist or vedolizumab within 8 weeks prior to screening, ustekinumab 12 weeks prior to screening, or any other biologic agent within 8 weeks prior to Screening or within 5 half-lives of the biologic agent prior to screening, whichever is longer

    - Currently have complications of CD as any of the following:
    a) Symptomatic strictures, OR
    b) Severe (impassable) rectal/anal stenosis, OR
    c) Fistulae, OR
    d) Short bowel syndrome, OR
    e) Any other complications which could preclude the use of the CDAI to assess response to therapy, or would possibly confound the evaluation of benefit from treatment with filgotinib
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects with a ≥ 50% decrease from baseline in sperm concentration at Week 13.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of week 13
    E.5.2Secondary end point(s)
    The proportion of subjects with a ≥ 50% decrease from baseline in sperm concentration at Week 26
    Change from baseline in percent motile sperm at Weeks 13 and 26
    Change from baseline in total sperm count at Weeks 13 and 26
    Change from baseline in sperm concentration at Weeks 13 and 26
    Change from baseline in ejaculate volume at Weeks 13 and 26
    Change from baseline in percent normal sperm morphology at Weeks 13 and 26
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of week 26
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Austria
    Canada
    France
    Germany
    India
    Italy
    Netherlands
    New Zealand
    Poland
    Portugal
    Russian Federation
    Sri Lanka
    Switzerland
    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 reached when the last subject completes the LTE Week
    195 visit, or when the last subject completes his last visit, whichever is sooner.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days13
    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: 250
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 124
    F.4.2.2In the whole clinical trial 250
    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 completion of at least 26 weeks of study drug, all subjects who did not experience a decrease of ≥ 50% in sperm concentration from Baseline, and who are disease responders will be offered the option to enter into the LTE portion of the study. Responders will continue on the same study drug that they were responding to.The long-term care of subjects who do not qualify for LTE or choose not to participate will remain the responsibility of their primary treating physician.
    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 Decision2017-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-29
    P. End of Trial
    P.End of Trial StatusOngoing
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