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Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome — TWINSS Extn  

Sjogren's Syndrome Clinical Trial

Official title:
A TWINSS Extension Trial to Evaluate the Safety and Tolerability of CFZ533 (Iscalimab) at Two Dose Levels Administered Subcutaneously in Patients With Sjögren's Syndrome

Clinical Trial Summary

This study will evaluate the safety and tolerability of iscalimab at two dose levels in patients with Sjögren's Syndrome, who participated in the TWINSS core study, CCFZ533B2201(NCT03905525). Additionally, this Extension study will further explore the pharmacokinetics (PK) and efficacy of iscalimab at two dose level.

Clinical Trial Description

This Extension study is a 48-week treatment study, with a safety follow-up period of 12 weeks. This study will evaluate the safety and tolerability of iscalimab at two dose levels in patients with Sjögren's Syndrome, who must have participated in the TWINSS core study, CCFZ533B2201 (NCT03905525) and must have completed the entire treatment period up to Week 48 and the follow-up period up to Week 60. Study treatment will be administered as bi-weekly subcutaneous injections (Q2W s.c.) via prefilled syringes (PFS). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04541589
Study type Interventional
Source Novartis
Contact
Status Active, not recruiting
Phase Phase 2
Start date January 5, 2021
Completion date July 31, 2024
View Details
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