Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)
Recruiting in Palo Alto (17 mi)
+61 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Novartis Pharmaceuticals
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of this study was to determine the dose-response relationship of VAY736 for key efficacy and safety parameters
Eligibility Criteria
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.
Treatment Details
Interventions
- Placebo (Other)
- VAY736 (Monoclonal Antibodies)
Participant Groups
4Treatment groups
Experimental Treatment
Placebo Group
Group I: VAY736 dose 3 - 300 mgExperimental Treatment1 Intervention
VAY736 high
Group II: VAY736 dose 2 - 50mgExperimental Treatment1 Intervention
VAY736 medium
Group III: VAY736 dose 1 - 5mgExperimental Treatment1 Intervention
VAY736 low
Group IV: PlaceboPlacebo Group1 Intervention
Placebo control
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Novartis Investigative SiteWexford, PA
Novartis Investigative SiteRochester, NY
Novartis Investigative SitePittsburgh, PA
Novartis Investigative SiteHouston, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Novartis PharmaceuticalsLead Sponsor