PD of VAY736 in Patients With Primary Sjögren's Syndrome
| Status: | Recruiting |
|---|---|
| Conditions: | Rheumatology |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 12/5/2015 |
| Start Date: | May 2014 |
| End Date: | June 2017 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | 1-888-669-6682 |
A Single Dose, Double-blind, Placebo-controlled, Parallel Study to Assess the Pharmacodynamics, Pharmacokinetics and Safety and Tolerability of VAY736 in Patients With Primary Sjögren's Syndrome
This study is designed to evaluate the safety, tolerability, pharmacokinetics and
therapeutic efficacy of a single intravenous infusion of VAY7346 monoclonal antibody in pSS
patients
therapeutic efficacy of a single intravenous infusion of VAY7346 monoclonal antibody in pSS
patients
INCLUSION CRITERIA:
- Fulfilled revised European US consensus criteria for pSS
- ESSDAI value ≥ 6
- Elevated serum titers at screening of ANA (≥ 1:160)
- Seropositive at screening for anti-SSA and/or anti-SSB antibodies
- Stimulated whole salivary flow rate at screening of > 0 mL/min
EXCLUSION CRITERIA:
- Prior or previous use of (specific dosages and intervals prior to study start may
apply): B-cell depleting therapy (e.g., rituximab), Prednisone, anti-BAFF mAb, CTLA4-Fc Ig
(abatacept), anti-TNF-α mAb, cyclophosphamide, azathioprine and medications known to cause
dry mouth.
Hydroxychloroquine or methotrexate in a consistent dose for ≥ 3 months prior to
randomization is allowed
- Active or recent history of clinically significant infection
- Vaccination within 2 month prior to study
- History of primary or secondary immunodeficiency
- Other protocol-defined inclusion/exclusion criteria may apply.
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