Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03905525
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 2
Start date October 1, 2019
Completion date June 6, 2023

See also
  Status Clinical Trial Phase
Completed NCT02752269 - Early Detection of Pulmonary- and Pulmonary Vascular Disease in Sjögren Syndrome
Completed NCT05079581 - Pelvic Floor Exercises in Patients With Sjögren's N/A
Completed NCT04819269 - Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome Phase 3
Completed NCT02011776 - A Randomized, Parallel-Group Comparison Study of Topical Corticosteroids in Dry Eye Patients With Sjögren Syndrome N/A
Recruiting NCT06411132 - Study to Evaluate Corneal Neurosensory Abnormalities in Patients With Sjögren's Dry Eye
Completed NCT03762824 - Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease Phase 4
Terminated NCT04035668 - A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome Phase 2
Completed NCT02049112 - A New Oral salIvary equivAlent Compared to Two moisturizinG Mouth sprAys in Patients With xeRostomiA: NIAGARA Study Phase 4
Recruiting NCT04848870 - Dental and Periodontal Status of Patients With Sjögren's Syndrome.
Completed NCT03941184 - Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity
Completed NCT03608761 - Comparison Between Rebamipide 2% Versus Autologous Serum Phase 4
Active, not recruiting NCT04793646 - N-acetylcysteine for Primary Sjögren's Syndrome N/A