NCT03905525

Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome

A 48-week, 6-arm, Randomized, Double-blind, Placebo-controlled Multicenter Trial to Assess the Safety and Efficacy of Multiple CFZ533 Doses Administered Subcutaneously in Two Distinct Populations of Patients With Sjogren's Syndrome (TWINSS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 273 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome.

Detailed description

This is a double-blind, randomized, placebo-controlled, multicenter study of CFZ533 in 2 distinct populations (cohorts) of patients with Sjögren's Syndrome: 1) moderate-to-severe disease (systemic and symptomatic involvement) and; 2) low systemic involvement but high symptom burden. The study includes up to 6 weeks screening period, 48 weeks of treatment (divided into treatment periods of 24 weeks each) and 12 weeks follow up. Study treatment will be administered as bi-weekly subcutaneous injections.

Conditions

• Sjögren Syndrome

Interventions

Type	Name	Description
DRUG	CFZ533	Biological
OTHER	Placebo	liquid placebo for injections

Timeline

• Start date: 2019-10-01
• Primary completion: 2022-09-28
• Completion: 2023-06-06
• First posted: 2019-04-05
• Last updated: 2023-09-15

Locations

71 sites across 23 countries: United States, Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, Portugal, Romania, Russia, South Korea, Sweden, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study