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

Completed · Phase 2 · Has a placebo group

Conditions studied: Primary Sjogren Syndrome

In brief

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

Key facts

Study ID

NCT02962895

Run by

Novartis Pharmaceuticals

People needed

190

Starts

2017-06-27

Expected to finish

2021-09-23

Last updated by the study team

2025-01-07

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Indiana Univ School of Dentistry — Indianapolis, Indiana, United States
• The John Hopkins Jerome L Greene Sjogren — Baltimore, Maryland, United States
• Tufts School of Dental Medicine — Boston, Massachusetts, United States
• AAIR Research Center — Rochester, New York, United States
• UPMC — Pittsburgh, Pennsylvania, United States
• Advanced Rheumatology and Arthritis Wellness Center — Wexford, Pennsylvania, United States
• Baylor College Of Medicine — Houston, Texas, United States
• First Outpatient Research Unit — San Antonio, Texas, United States
• Novartis Investigative Site — Ciudad Autonoma de Bs As, Buenos Aires, Argentina
• Novartis Investigative Site — CABA, Argentina
• Novartis Investigative Site — Córdoba, Argentina
• Novartis Investigative Site — Córdoba, Argentina
• Novartis Investigative Site — Graz, Austria
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Santiago, Chile
• Novartis Investigative Site — Santiago, Chile
• Novartis Investigative Site — Brest, France
• Novartis Investigative Site — Lille, France
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Freiburg im Breisgau, Germany
• Novartis Investigative Site — München, Germany
• Novartis Investigative Site — Würzburg, Germany
• Novartis Investigative Site — Budapest, Hungary
• Integral Rheumatology and Immunology Specialists IRIS — Plantation, Florida, United States

Full record on ClinicalTrials.gov

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