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 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 withing 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 randomisation (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 Outcome Measures

Name	Time	Method

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