Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients

Exclusion Criteria

• •1. Prior administration within the timeframe described in the protocol of any of the following:
• •* Belimumab,
• •* Rituximab or other B cell depleting agents,
• •* Abatacept,
• •* Tumor necrosis factor inhibitors,
• •* Tocilizumab,
• •* Cyclophosphamide,
• •* Cyclosporine (except for eye drops), tacrolimus, sirolimus, mycophenolate mofetil (MMF), azathioprine, or leflunomide
• •* Janus kinase (JAK) inhibitors
• •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; 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 pilocarpine and cyclosporine eye drops (Restasis) and lifitegrast: any increase or initiation of new doses within 2 weeks prior to randomisation (W000).
• •3. Secondary Sjögren's Syndrome