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

Study Purpose

This study will determine the dose-response relationship of VAY736 for key efficacy and safety parameters

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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.

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02962895
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Novartis Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Austria, Belgium, Chile, France, Germany, Hungary, Israel, Italy, Japan, Netherlands, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Primary Sjogren's Syndrome

Arms & Interventions

Arms

Experimental: VAY736 dose 1

VAY736 low

Experimental: VAY736 dose 2

VAY736 medium

Experimental: VAY736 dose 3

VAY736 high

Placebo Comparator: Placebo

Placebo control

Interventions

Biological: - VAY736

VAY736

Other: - Placebo

Placebo control

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Novartis Investigative Site, Boca Raton, Florida

Status

Recruiting

Address

Novartis Investigative Site

Boca Raton, Florida, 33486

Site Contact

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