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    EudraCT Number:2020-001526-59
    Sponsor's Protocol Code Number:CL2-95011-001
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-08-03
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2020-001526-59
    A.3Full title of the trial
    A phase IIa efficacy and safety trial with intravenous S95011 in primary Sjögren’s Syndrome patients. An international, multicentre, randomised, double-blind, placebo-controlled study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of S95011 in primary Sjögren’s Syndrome patients
    A.4.1Sponsor's protocol code numberCL2-95011-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04605978
    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 SponsorInstitut de Recherches Internationales Servier
    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 supportADIR
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recherches Internationales Servier
    B.5.2Functional name of contact pointClinical Studies Department
    B.5.3 Address:
    B.5.3.1Street Address50 rue Carnot
    B.5.3.2Town/ citySURESNES CEDEX
    B.5.3.3Post code92284
    B.5.4Telephone number+33155 72 43 66
    B.5.5Fax number+33155725412@fax.servier.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 nameS95011
    D.3.2Product code S95011
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNS95011
    D.3.9.1CAS number 2375835-91-7
    D.3.9.2Current sponsor codeS95011
    D.3.9.3Other descriptive nameOSE-127
    D.3.9.4EV Substance CodeSUB213471
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Sjögren’s Syndrome
    E.1.1.1Medical condition in easily understood language
    Primary Sjögren’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 assess the effect of multiple intravenous infusions of 750 mg of S95011 compared to placebo after 13 weeks of treatment in reducing disease activity using European League Against Rheumatism (EULAR) Sjögren Syndrome Disease Activity Index (ESSDAI)
    E.2.2Secondary objectives of the trial
    - To evaluate efficacy of multiple intravenous infusions of 750 mg of S95011 compared to placebo after 13 weeks of treatment
    - To assess the safety and tolerability of multiple intravenous infusions of S95011.
    - To assess the pharmacokinetics (PK) of S95011 in serum.
    - To assess pharmacodynamics [receptor occupancy (RO)] of S95011 in blood.
    - To determine the incidence of anti-drug antibodies (ADA) formation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Diagnosis of primary Sjögren’s Syndrome based on 2016 ACR-EULAR criteria
    2.ESSDAI total score ≥ 6 during screening, with at least 6 points scored within the 7 following domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, hematologic and biologic,
    3.Positive anti-SSA (Ro) antibodies or anti-nuclear antibodies (ANA) ≥1:320 or rheumatoid factor (RF) >20 IU/ml during screening period, measured in a central laboratory
    4.Stimulated whole salivary flow rate > 0 mL/minute
    E.4Principal exclusion criteria
    1.Prior administration of any of the following:
    - Belimumab in the past 6 months prior to randomisation (W000)
    - Rituximab or other B cell depleting agents e.g. VAY736 in the past 24 months prior to randomisation (W000).
    - Abatacept in the past 3 months prior to randomisation (W000),
    - Tumor necrosis factor inhibitors (adalimumab, certolizumab, etanercept, golimumab, infliximab, and biosimilars) in the past 3 months prior to randomisation (W000)
    - Tocilizumab in the past 3 months prior to randomisation (W000)
    - Cyclophosphamide (or any other alkylating agent) in the past 6 months prior to randomisation (W000);
    - Cyclosporine (except for eye drops), tacrolimus, sirolimus, mycophenolate mofetil (MMF), azathioprine, or leflunomide in the past 3 months prior to randomisation (W000)
    - Janus kinase (JAK) inhibitors in the past 1 week prior to randomisation (W000)

    2. Meeting any of the following conditions:
    - Corticosteroids: > 10 mg/day oral prednisone (or equivalent) within 4 weeks prior to randomisation (W000); Any change or initiation of new dose of oral prednisone (or equivalent) within 4 weeks prior to randomisation (W000); Intramuscular, IV, or intra-articular corticosteroids within 4 weeks prior to randomisation (W000); Any change or initiation of new dose of topical corticosteroids within 2 weeks prior to randomisation (W000)
    - Antimalarials: any change or initiation of new dose of antimalarials (e.g. chloroquine, hydroxychloroquine, quinacrine) within 16 weeks prior to randomisation (W000)
    - Methotrexate: > 25 mg/week of methotrexate within 12 weeks prior to randomisation (W000); any initiation or change of dose of methotrexate within 12 weeks prior to randomisation (W000); any change in route of administration within 4 weeks prior to randomisation (W000);
    - Non-steroidal anti-inflammatory drugs (NSAIDs): Any change or initiation of new dose of regularly scheduled NSAIDs within 2 weeks prior to randomisation (W000)
    - Cevimeline or oral pilocarpine and cyclosporine eye drops (Restasis) and lifitegrast: any increase or initiation of new doses within 2 weeks prior to randomisation (W000)
    - Ocular topics (excluding artificial tears, gels, lubricants,
    antibiotherapy): any dose modification or initiation of new doses within 90 days prior to randomisation (W000).
    - Required regular use of medications known to cause dry mouth/eyes
    as a regular and major side effect, and which have not been on a stable dose for at least 30 days prior to randomization (W000), or any
    anticipated change in the treatment regimen during the course of the
    E.5 End points
    E.5.1Primary end point(s)
    Change in ESSDAI total score
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to W013
    E.5.2Secondary end point(s)
    - ESSDAI score by domain and total score
    - ESSPRI score by symptom and total score
    - Proportion of patients with ≥ 3 points, ≥ 5 points, ≥ 7 points of improvement from baseline in ESSDAI
    - Proportion of patients with ≥ 1 point, ≥ 2 points, ≥ 3 points of improvement from baseline in ESSPRI
    - Proportion of patients with ≥ 3 points of improvement in ESSDAI and with ≥ 1 point of improvement in ESSPRI
    - Quality of life (SF-36), fatigue (MFI), physician and patient’s global assessment of the disease activity
    - Tear gland function: Schirmer’s test and OSS
    - Salivary gland function: unstimulated and stimulated salivary flow rate

    Other secondary endpoint: Incidence of adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    - ESSDAI score by domain and total score: at W0, W4 and W13
    - ESSPRI score by symptom and total score: at W0, W4 and W13
    - Quality of life (SF-36), fatigue (MFI), physician and patient's global
    assessment of the disease activity: at W0 and W13
    - Others: at each visit of the patient

    - Incidence of adverse events: throughout the study
    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 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. 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 concerned2
    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
    United States
    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
    The date of the last follow-up of the last patient (including a phone contact), or the date of the last contact attempt if the last patient is declared lost to follow-up
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 45
    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 discontinuation of the IMP, the patients’ medical care is left at the physician’s discretion.
    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 Decision2020-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-05-02
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