Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients
- Conditions
- Primary Sjögren's Syndrome
- Interventions
- Drug: S95011 concentrate for solution for infusionDrug: Placebo concentrate for solution for infusion
- Registration Number
- NCT04605978
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S95011 concentrate for solution for infusion S95011 concentrate for solution for infusion S95011 is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. S95011 Placebo concentrate for solution for infusion Placebo concentrate for solution for infusion S95011 placebo is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
- Primary Outcome Measures
Name Time Method Change in ESSDAI Total Score From baseline to week 13 Efficacy criterion Eular Sjögren Syndrome Disease Activity index (ESSDAI) is a physician-administered clinical index which has been validated to objectively assess systemic manifestations in Primary Sjögren's Syndrome patients. Scores range from 0 - 123, with a lower score representing less disease activity.
- Secondary Outcome Measures
Name Time Method Patient's Global Assessment (PGA) of the Disease Activity At baseline and week 13 Efficacy criterion Patient's global assessment (PGA) of the disease activity is a 0 to 10 numerical rating scale (NRS), with a lower score representing less disease activity.
ESSDAI Score by Domain and Total Score At baseline, week 4 and week 13 Efficacy criterion Eular Sjögren Syndrome Disease Activity index (ESSDAI) is a physician-administered clinical index which has been validated to objectively assess systemic manifestations in Primary Sjögren's Syndrome patients. There are 12 organ-specific domains and for each domain, features of disease activity are scored according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score. The total score ranges from 0 to 123. A higher score always represents a more severe disease activity. The domain \[weight\] and score range are as follows: Constitutional \[3\] 0-2; Lymphadenopathy and lymphoma \[4\] 0-3; Glandular \[2\] 0-2; Articular \[2\] 0-3; Cutaneous \[3\] 0-3; Pulmonary \[5\] 0-3; Renal \[5\] 0-3; Muscular \[6\] 0-3; PNS \[5\] 0-3; CNS \[5\] 0-3; Hematological \[2\] 0-3; Biological \[1\] 0-2.
Fatigue (MFI) At baseline and week 13 Efficacy criterion Modified Fatigue Impact Scale (MFI) is a 20-item survey to evaluate five dimensions of fatigue. Scores range from 4 to 20 for each sub-score, with a lower score representing less fatigue.
Physician's Global Assessment (PhGA) of the Disease Activity At baseline and week 13 Efficacy criterion Physician's global assessment (PhGA) of the disease activity is a 0 to 10 numerical rating scale (NRS), with a lower score representing less disease activity.
ESSPRI Score by Symptom and Total Score At baseline, week 4 and week 13 Efficacy criterion EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is an index designed to measure patients' symptoms in primary Sjögren's Syndrome. The three domains included in this scale are dryness, fatigue, and pain, each of which are scored on a scale of 0-10. The total score is calculated as the average of the three domain scores and therefore the maximum total score is 10. The higher score represents more severe symptoms.
Quality of Life (SF-36) At baseline and week 13 Efficacy criterion The Short Form (SF-36) Health Survey is a 36-item, patient-reported survey of patient health to asses QoL. Scores for each subscale range from 0 - 100, with a lower number representing a worse quality of life.
Number of Participants With Adverse Events (AEs) Through study completion, up to Week 28 Safety criterion
Trial Locations
- Locations (19)
Hôpital Laribiosière
🇫🇷Paris, France
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Hôpital Pitié-Salpêtrière
🇫🇷Paris, France
Hôpital Saint Antoine
🇫🇷Paris, France
Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust
🇬🇧Newcastle Upon Tyne, United Kingdom
Universitätsklinikum Freiburg Department Innere Medizin Klinik für Rheumatologie und Klinische Immunologie
🇩🇪Freiburg, Germany
Békés Megyei Központi Kórház, Pándy Kálmán Tagkórház, Infektológia-Hepatológia
🇭🇺Gyula, Hungary
Hospital Infanta Luisa Quirón Salud Servicio de Reumatología
🇪🇸Sevilla, Spain
CLINICAL GAIAS SANTIAGO Servicio de Reumatología
🇪🇸Santiago De Compostela, Spain
CHU de Bicêtre
🇫🇷Le Kremlin-Bicêtre, France
Debreceni Egyetem Orvos és Egészségtudományi Centrum Belgyógyászat C épület - Klinikai Immunológiai Tanszék
🇭🇺Debrecen, Hungary
Southampton General Hospital, University Hospital Southampton NHS Trust
🇬🇧Southampton, United Kingdom
Vita Verum Medical Bt. Berényi u. 72-100. 95. számú épület 16. Rendelő
🇭🇺Székesfehérvár, Hungary
Colorado Arthritis Associates
🇺🇸Lakewood, Colorado, United States
The Queen Elizabeth Hospital Rheumatology Unit
🇦🇺Woodville, Australia
Universitätsklinikum Erlangen Medizinische Klinik 3 Rheumatologie und Immunologie
🇩🇪Erlangen, Germany
CLINICA SAGRADA FAMILIA Servicio de Reumatología y Unidad de Ensayos Clínicos
🇪🇸Barcelona, Spain
Hôpital Saint-André
🇫🇷Bordeaux, France