CompletedPhase 2

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

United States, Australia, France48 participantsStarted 2021-08-03

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. Prior administration within the timeframe described in the protocol of any of the following:
✕. Meeting any of the following conditions:
✕. Secondary Sjögren's Syndrome

What they're measuring

Change in ESSDAI Total Score

Timeframe: From baseline to week 13

Trial details

NCT IDNCT04605978

SponsorInstitut de Recherches Internationales Servier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-16

Results submitted2024-01-15

View on ClinicalTrials.gov More Primary Sjögren's Syndrome trials