Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome

• Status: Completed
• Trial end date: 2018-06-29
• Target enrollment: 0
• Participant gender: All

Summary

This study did evaluate the safety,tolerability and preliminary therapeutic efficacy of multiple doses of intravenous infusion of CFZ533 monoclonal antibody in patients with primary Sjögren's syndrome(pSS)

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Diagnosis of primary Sjögren's syndrome

• ESSDAI score ≥ 6

Exclusion Criteria:

• Secondary Sjögren's syndrome

• Receiving cyclosphosphamide, corticosteroid bolus with dose over 1 mg/kg, rituximab, belimunab, other immunosuppressives.

• At significant risk for thromboembolic event

• Clinically significant systemic infection

• Significant elevated risk for infection