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    Summary
    EudraCT Number:2018-003933-14
    Sponsor's Protocol Code Number:GLPG0634-CL-227
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-04-29
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2018-003933-14
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.
    Randomizované, dvojitě zaslepené, placebem kontrolované klinické hodnocení fáze 2 posuzující účinnost filgotinibu na parametry spermií u dospělých mužů s aktivní
    revmatoidní artritidou, psoriatickou artritidou, ankylozující spondylitidou nebo neradiografickou axiální spondylartritidou.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.
    A.4.1Sponsor's protocol code numberGLPG0634-CL-227
    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 SponsorGalapagos NV
    B.1.3.4CountryBelgium
    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 supportGalapagos NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGalapagos NV
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressGeneraal De Wittelaan L11 A3
    B.5.3.2Town/ cityMechelen
    B.5.3.3Post code2800
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3215342900
    B.5.5Fax number+3215342901
    B.5.6E-mailrd@glpg.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 GLPG0634
    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
    Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
    E.1.1.1Medical condition in easily understood language
    Rheumatic diseases
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076297
    E.1.2Term Non-radiographic axial spondyloarthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    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
    - Male between the ages of 21 and 65 (inclusive) on the day of signing informed consent.
    - Diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nrAxSpA) for at least 12 weeks prior to screening, meeting the corresponding specific classification criteria:
    a) RA, American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) 2010
    b) PsA, Classification criteria for Psoriatic Arthritis (CASPAR) criteria
    c) AS or nrAxSpA, Assessment of Spondyloarthritis International Society (ASAS) criteria for axial spondyloarthritis
    - For RA, PsA, AS, or nrAxSpA, meets the following criteria:
    a) RA:
    i) Inadequate response or intolerant to an ≥12-week course of csDMARD or biological DMARD (bDMARD) therapy for RA
    ii) Have a Clinical Disease Activity Index (CDAI) >10 at screening
    b) PsA
    i) Inadequate response or intolerant ≥12-weeks’ course of csDMARD or bDMARD therapy for PsA
    ii) Have a Disease Activity in Psoriatric Arthritis (DAPSA) score >14 at screening
    c) Axial Spondyloarthritis (applicable to those with diagnosis of AS or nrAxSpA)
    i) Inadequate response or intolerant to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), which may include cyclooxygenase-2 (COX-2 inhibitors) prescribed for a total period of ≥4 weeks OR to an at least 12 weeks’ course of csDMARD or bDMARD therapy for spondyloarthritis
    ii) Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 at screening
    iii) At screening, subjects should have a C-reactive protein (CRP) >0.3 mg/dL OR sacroiliitis according to the modified New York (NY) criteria OR a history of active inflammation on magnetic resonance imaging (MRI) consistent with sacroiliitis within two year of screening
    - If using csDMARD therapy, subjects are permitted to use one of the
    following drugs, alone or in combination and must have been on a stable
    dose of the drug for at least 4 weeks prior to Screening and remain on a
    stable dose during the Double-blind treatment phase of the study (stable
    dose in all cases is defined as no change in prescription):
    a) MTX oral or parenteral up to 25 mg/week (with concomitant use of folic or folinic acid supplementation as per local standard of care)
    b) Leflunomide (LEF) up to 20 mg/day orally
    c) Hydroxychloroquine up to 400 mg/day or chloroquine up to 250 mg/day orally
    d) Apremilast orally up to 30 mg twice daily orally
    Note that sulfasalazine is not permitted at any time, beginning 26 weeks prior to Screening until the end of the study, and cannot be included in the standard of care arthritis regimen, due to its potential impact on semen parameters
    - The mean of 2 separate semen samples collected at Screening must meet the following minimum criteria: 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 reference ranges at Screening

    This list only contains the key inclusion criteria.

    E.4Principal exclusion criteria
    - 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 spirinolactone, oral ketoconazole, or cyproterone acetate), or
    treatment within 4 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
    - Any sexual dysfunction of a nature that would prevent sperm collection
    in accordance with protocol guidance (phosphodiesterase inhibitors,
    however, are permitted during the study)

    This list only contains the key exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    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
    At baseline and at 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
    At baseline, at week 13 and at 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 No
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Open label after week 13
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA66
    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
    Estonia
    Latvia
    Poland
    Bulgaria
    Spain
    Czechia
    Ukraine
    E.8.7Trial has a data monitoring committee No
    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 scheduled study visit occurred. This can be a Week 156 visit, a Follow-up visit, or the last visit of a Monitoring Phase.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 106
    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)
    None
    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 Decision2019-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-05-10
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