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    Summary
    EudraCT Number:2020-003298-22
    Sponsor's Protocol Code Number:GLPG3970-CL-207
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-30
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2020-003298-22
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GLPG3970 for 12 weeks in adult subjects with active primary Sjögren’s Syndrome
    Randomizált, kettős vak, placebo-kontrollált, multicentrikus vizsgálat a 12 héten át szájon át alkalmazott GLPG3970 készítmény hatásosságának, biztonságosságának, tolerálhatóságának, farmakokinetikájának és farmakodinámiájának értékelésére, aktív primer Sjögren-szindrómában szenvedő felnőtt betegek esetében.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating the effects of GLPG3970 given as an oral treatment for 12 weeks in adults with active primary Sjögren’s Syndrome
    A.4.1Sponsor's protocol code numberGLPG3970-CL-207
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04700280
    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 pointGalapagos Medical Information
    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.5.6E-mailmedicalinfo@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 nameGLPG3970
    D.3.2Product code G1567970
    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 INNNot applicable
    D.3.9.2Current sponsor codeG1567970
    D.3.9.3Other descriptive nameGLPG3970
    D.3.9.4EV Substance CodeSUB198844
    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
    Primary Sjogren's Syndrome
    E.1.1.1Medical condition in easily understood language
    Sjogren's Syndrome
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10040767
    E.1.2Term Sjogren's syndrome
    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 efficacy of GLPG3970 compared to placebo on the signs and symptoms of primary Sjögren's Syndrome.
    − To evaluate the safety and tolerability of GLPG3970 compared to placebo.
    E.2.2Secondary objectives of the trial
    - To further characterize the efficacy of GLPG3970 compared to placebo on the patient reported signs and symptoms of primary Sjögren's Syndrome.
    − To characterize the pharmacokinetics (PK) of GLPG3970.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    − Male or female subject between 18-74 years of age (extremes included), on the date of signing the informed consent form (ICF).
    − Documented diagnosis of pSS for <10 years prior to screening AND defined by the classification criteria >=4 described by the American College of Rheumatology - European League Against Rheumatism (ACR-EULAR).
    − Subject has an ESSDAI score >=5 assessed on 7 domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, hematological, and biological.
    − Subject has an ESSPRI score >=5.
    − Subject has stimulated whole salivary flow rate of >=0.1 mL/min.
    − Subject has positive serum titers of anti-SS-A/Ro and/or anti-SS-B/La antibodies.
    − Subjects already on treatment should be on stable standard of care (SoC) for at least 4 weeks prior to first IP dosing.
    The following SoC medications are permitted:
    • Corticosteroids <=7.5 mg/day (prednisone or equivalent); AND/OR
    • Non-steroidal anti-inflammatory drugs (NSAIDs); AND/OR
    • One single antimalarial at a stable dose (hydroxychloroquine <=400 mg/day; quinacrine 100 mg/kg/day, or chloroquine <=250 mg/day); AND/OR
    • One single immunosuppressant at a stable dose (methotrexate [MTX] <=10 mg/week or azathioprine [AZA] <=2 mg/kg/day); AND/OR
    • One single cholinergic stimulant at a stable dose (e.g. pilocarpine, cevimeline).
    − Female subject of childbearing potential must have a negative highly sensitive (serum beta human chorionic gonadotropin or urine dipstick) pregnancy test.
    − Female subject of childbearing potential or male subject must agree to use highly effective contraception/preventive exposure measures.

    This list only contains the key inclusion criteria.
    E.4Principal exclusion criteria
    − Secondary Sjögren's syndrome according to the ACR-EULAR (2016) classification.
    − History or presence of unstable condition not related to Sjögren’s Syndrome that, in the opinion of the investigator, could constitute an unacceptable risk when taking the IP or interfere with the interpretation of data.
    − Subject has any active systemic infection within 2 weeks prior to first IP dosing, or poorly controlled chronic cardiac, pulmonary, or renal disease.
    − Subject has a known or suspected history of or a current immunosuppressive condition, or a history of opportunistic infections (e.g. human immunodeficiency virus [HIV] infection, histoplasmosis, listeriosis, coccidiodmycosis, pneumocystosis, aspergillosis).
    − Subject has a chronic hepatitis B virus (HBV) infection, as defined by persistent HBV surface antigen (HBsAg) positivity. Subject has hepatitis C virus (HCV) infection, as defined by positive HCV antibody at screening and detectable HCV viremia. Subjects with positive HCV antibody must undergo reflex HCV ribonucleic acid (RNA) testing,
    and subjects with HCV RNA positivity will be excluded. Subjects with positive HCV antibody and negative HCV RNA are eligible.
    − Subject testing positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as detected at screening based on real time polymerase chain reaction (RT-PCR) or at baseline based on immunoglobulin M (IgM) immunoassay, or subjects who have been in contact with SARS-CoV-2 infected individuals in the 2 weeks prior to first dosing of IP. Subjects presenting any signs or symptoms of SARS-CoV-2 infection, prior to first IP dosing following careful physical examination (e.g. cough, fever, headaches, fatigue, dyspnea, myalgia, anosmia, dysgeusia, anorexia, sore throat,
    etc). In addition, any other locally applicable standard diagnostic criteria may also apply to rule out SARS-CoV-2 infection.
    − Subject has taken any disallowed therapies:
    • Mycophenolate mofetil (MMF) within a week prior to screening.
    • Cyclosporine/Tacrolimus within a week prior to screening.
    • Cyclophosphamide within 6 months prior to screening.
    • Ocular medicines (e.g. topical cyclosporine, topical NSAIDs/ corticosteroids) for at least 4 weeks prior to screening, except for a sporadic use.
    • Biologics such as, but not limited to, rituximab, abatacept, and any other unapproved biologic within 6 months prior to screening.
    • Plasmapheresis within 12 weeks prior to screening.
    • Plasma exchange within 12 weeks prior to screening.
    • Intravenous immunoglobulin (IVIG) therapy within 24 weeks prior to screening.
    • Other prohibited medications within 2 weeks or 5 half-lives
    whichever is longer prior to first IP dosing, as listed in the clinical study protocol
    − Concurrent use of anticholinergic agents or any other medication
    known to cause dry mouth/dry eyes that, in the opinion of the investigator, are a contributing factor to the subject’s dryness and/or
    use of anticholinergic agents not contributing to this dryness, if not
    stable at least 4 weeks prior to screening.
    − Subject has a history of tuberculosis (TB) diagnosis or evidence of active or latent infection with Mycobacterium tuberculosis.
    − Subject has a history of lymphoma or any malignancy within the past 5 years prior to screening with the exception of excised and curatively treated non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of cervix which is considered cured with minimal risk of recurrence.
    - Subject has severe organ manifestation or life-threatening condition, or has planned a surgery during the study.

    This list only contains the key exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    - Change from baseline in European League Against Rheumatism (EULAR) Sjögren’s Syndrome Disease Activity Index (ESSDAI) score at Week 12.
    − Number, incidence, and severity of treatment-emergent adverse events (TEAEs).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Various timepoints during the trial as per clinical study design.
    E.5.2Secondary end point(s)
    - Change from baseline in EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) score at Week 4, 8, and 12.
    − Change from baseline in EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) score over time at Week 4, 8, and 12.
    − Observed GLPG3970 plasma trough concentration (Ctrough).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various timepoints during the trial as per clinical study design.
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Ukraine
    France
    Germany
    Hungary
    Netherlands
    Poland
    Spain
    United Kingdom
    Greece
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 26
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 23
    F.4.2.2In the whole clinical trial 30
    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 Decision2021-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-01-27
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