Efficacy and safety of S95011 in primary Sjögren’s Syndrome patients

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 45

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

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
study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: - To evaluate efficacy of multiple intravenous infusions of 750 mg of S95011 compared to placebo after 13 weeks of treatment <br>- To assess the safety and tolerability of multiple intravenous infusions of S95011. <br>- To assess the pharmacokinetics (PK) of S95011 in serum.<br>- To assess pharmacodynamics [receptor occupancy (RO)] of S95011 in blood.<br>- To determine the incidence of anti-drug antibodies (ADA) formation.<br>;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);Primary end point(s): Change in ESSDAI total score ;Timepoint(s) of evaluation of this end point: From baseline to W013

Secondary Outcome Measures

Name	Time	Method

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