NCT02291029

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

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CFZ533 in Patients With Primary Sjögren's Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Primary Sjögren's Syndrome

Interventions

Type	Name	Description
DRUG	CFZ533 active - Cohort 1	multiple doses of CFZ533 s.c. injection
DRUG	CFZ533 placebo- Cohort 1	multiple doses of placebo s.c. injection
DRUG	CFZ533 active - Cohort 2	multiple doses of CFZ533 intravenous infusion
DRUG	CFZ533 placebo - Cohort 2	multiple doses of placebo intravenous infusion
DRUG	CFZ533 active -Cohort 3	multiple doses of CFZ533 s.c. injection
DRUG	CFZ533 active - Cohort 3	Single dose of CFZ533 i.v. infusion and multiple doses of CFZ533 s.c. injection

Timeline

• Start date: 2014-10-22
• Primary completion: 2018-06-29
• Completion: 2018-06-29
• First posted: 2014-11-14
• Last updated: 2021-01-05
• Results posted: 2019-08-14

Locations

9 sites across 5 countries: United States, Germany, Hungary, Switzerland, United Kingdom