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

Completed · Phase 2 · Has a placebo group

Conditions studied: Primary Sjögren's Syndrome

In brief

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)

Key facts

Study ID

NCT02291029

Run by

Novartis Pharmaceuticals

People needed

69

Starts

2014-10-22

Expected to finish

2018-06-29

Last updated by the study team

2021-01-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of primary Sjögren's syndrome
• ESSDAI score ≥ 6

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Mineola, New York, United States
• Novartis Investigative Site — Duncansville, Pennsylvania, United States
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Debrecen, Hungary
• Novartis Investigative Site — Basel, Switzerland
• Novartis Investigative Site — Edgbaston, Birmingham, United Kingdom
• Novartis Investigative Site — London, United Kingdom
• Novartis Investigative Site — Newcastle upon Tyne, United Kingdom

Full record on ClinicalTrials.gov

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