At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 273 enrolled
Drug / intervention
CFZ533 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating CFZ533 and Placebo for Sjögren Syndrome. Completed, enrolled 273 participants across 71 sites in 23 countries.
Detailed Summary
This study was to evaluate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome (SjS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSjögren Syndrome
CountriesArgentina, Australia, Austria, Brazil, Canada, Chile, Colombia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, Portugal, Romania, Russia, South Korea, Sweden, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 2019
Enrollment StartOct 2019
Primary CompletionSep 2022
Study CompletionJun 2023
TodayJul 2026
First PostedApr 5, 2019
Enrollment StartOct 1, 2019
Primary CompletionSep 28, 2022
Study CompletionJun 6, 2023
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.2 years ago
Interventions
CFZ533drug
Biological
Placeboother
liquid placebo for injections