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

Completed · Phase 2 · Has a placebo group

Conditions studied: Primary Sjögren's Syndrome

In brief

The purpose of this study is to assess the effect of multiple intravenous infusions of S95011 compared to placebo in reducing disease activity in patients with primary Sjögren's syndrome.

Key facts

Study ID

NCT04605978

Run by

Institut de Recherches Internationales Servier

People needed

48

Starts

2021-08-03

Expected to finish

2023-05-09

Last updated by the study team

2024-04-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of primary Sjögren's Syndrome based on 2016 American College of Rheumatology-EULAR criteria
• 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,
• Positive anti-Sjögren's Syndrome A (Ro) antibodies or anti-nuclear antibodies (ANA) ≥ 1:320 or rheumatoid factor (RF) >20 IU/ml during screening period, measured in a central laboratory
• Stimulated whole salivary flow rate > 0 mL/minute

You may not qualify if…

• 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
• 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).
• Secondary Sjögren's Syndrome

Where it is running

• Colorado Arthritis Associates — Lakewood, Colorado, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• The Queen Elizabeth Hospital Rheumatology Unit — Woodville, Australia
• Hôpital Saint-André — Bordeaux, France
• CHU de Bicêtre — Le Kremlin-Bicêtre, France
• Hôpital Laribiosière — Paris, France
• Hôpital Pitié-Salpêtrière — Paris, France
• Hôpital Saint Antoine — Paris, France
• Universitätsklinikum Erlangen Medizinische Klinik 3 Rheumatologie und Immunologie — Erlangen, Germany
• Universitätsklinikum Freiburg Department Innere Medizin Klinik für Rheumatologie und Klinische Immunologie — Freiburg im Breisgau, Germany
• Debreceni Egyetem Orvos és Egészségtudományi Centrum Belgyógyászat C épület - Klinikai Immunológiai Tanszék — Debrecen, Hungary
• Békés Megyei Központi Kórház, Pándy Kálmán Tagkórház, Infektológia-Hepatológia — Gyula, Hungary
• Vita Verum Medical Bt. Berényi u. 72-100. 95. számú épület 16. Rendelő — Székesfehérvár, Hungary
• CLINICA SAGRADA FAMILIA Servicio de Reumatología y Unidad de Ensayos Clínicos — Barcelona, Spain
• CLINICAL GAIAS SANTIAGO Servicio de Reumatología — Santiago de Compostela, Spain
• Hospital Infanta Luisa Quirón Salud Servicio de Reumatología — Seville, Spain
• Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust — Birmingham, United Kingdom
• Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne, United Kingdom
• Southampton General Hospital, University Hospital Southampton NHS Trust — Southampton, United Kingdom

Full record on ClinicalTrials.gov

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