PD of VAY736 in Patients With Primary Sjögren's Syndrome

• Status: Completed
• Trial end date: 2018-02-07
• Target enrollment: 0
• Participant gender: All

Summary

This study was designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of a single intravenous infusion of VAY7346 monoclonal antibody in pSS patients

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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