CompletedPhase 2

Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)

United States190 participantsStarted 2017-06-27

Plain-language summary

The purpose of this study was to determine the dose-response relationship of VAY736 for key efficacy and safety parameters

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

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Inclusion Criteria: * Fulfilled revised American European Consensus Group criteria for pSS * Seropositive at screening for anti-Ro/SSA antibodies * Screening ESSDAI value \>=6 scored from 7 domains: articular, cutaneous, glandular, lymphoadenopathy, constitutional, biologic and hematologic. Exclusion Criteria: * Secondary Sjogren's syndrome * Use of other investigational drugs * Active viral, bacterial or other infections * Positive hepatitis B, hepatitis C, HIV or tuberculosis test results at screening

What they're measuring

Least Squares Mean Change From Baseline in ESSDAI Score at Week 24

Timeframe: Baseline, Week 24

Trial details

NCT IDNCT02962895

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-06-30

Results submitted2022-07-13

View on ClinicalTrials.gov More Primary Sjogren Syndrome trials