Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)
| Status: | Recruiting |
|---|---|
| Conditions: | Rheumatology |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 1/11/2019 |
| Start Date: | June 27, 2017 |
| End Date: | June 30, 2020 |
| Contact: | Novartis Pharmaceuticals |
| Email: | novartis.email@novartis.com |
| Phone: | 1-888-669-6682 |
Study of Safety and Efficacy of Multiple VAY736 Doses in Patients With Moderate to Severe Primary Sjogren's Syndrome (pSS)
This study will determine the dose-response relationship of VAY736 for key efficacy and
safety parameters
safety parameters
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
We found this trial at
14
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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