Primary Sjögren’s Syndrome MedDRA version: 21.0 Level: PT Classification code 10040767 Term: Sjogren's syndrome System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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 12 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) 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 study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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);Secondary Objective: - 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. ;Primary end point(s): Change in ESSDAI total score ;Timepoint(s) of evaluation of this end point: From baseline to W013 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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;Timepoint(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 | — |
Countries
Australia, Canada, France, Germany, Hungary, Spain, United Kingdom, United States
Contacts
Public ContactClinical Studies Department
Institut de Recherches Internationales Servier
Outcome results
None listed