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

Institut de Recherches Internationales Servier48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Primary Sjögren's Syndrome

Interventions

S95011 concentrate for solution for infusionDRUG

IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.

Placebo concentrate for solution for infusionDRUG

IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosis of primary Sjögren's Syndrome based on 2016 American College of Rheumatology-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-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 4. Stimulated whole salivary flow rate \> 0 mL/minute 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

Locations (19)

Colorado Arthritis Associates

Lakewood, Colorado, United States

Outcomes

Primary Outcomes

Change in ESSDAI Total Score

Time frame: From baseline to week 13

Secondary Outcomes

ESSDAI Score by Domain and Total Score

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.

Time frame: At baseline, week 4 and week 13

ESSPRI Score by Symptom and Total Score

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.

Time frame: At baseline, week 4 and week 13

Quality of Life (SF-36)

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.

Data from ClinicalTrials.gov

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