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

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224883

Enrollment

260

Registered

2019-09-24

Start date

2019-09-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjogren Syndrome

Interventions

investigational material(s) Generic name etc : INN of investigational material : iscalimab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Classification of Sjogren's Syndrome according to ACR/EULAR 2016 criteria (Shiboski et al 2017)

Exclusion criteria

Exclusion criteria: Sjogren's Syndrome overlap syndromes where another autoimmune rheumatic disease constitutes the principle illness

Design outcomes

Primary

Measure	Time frame
Efficacy Cohort 1 - Change in EULAR Sjogren Syndrome Disease Activity Index (ESSDAI) score Cohort 2 - Change in EULAR Sjogren Syndrome Patient Reported Index (ESSPRI) score	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Contacts

Public ContactHideki Maruyama

Novartis Pharma. K.K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026