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 Sjögren*s Syndrome (TWINSS)

Phase 2

Completed

• Conditions: Sjogren syndrome; 10003816

• Registration Number: NL-OMON52778
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 9

Inclusion Criteria

•Signed informed consent;
•Male or female patient >= 18 years of age;
•Classification of Sjögren's Syndrome according to ACR/EULAR 2016 criteria
(Shiboski et al 2017);
•Seropositive for anti-Ro/SSA antibodies;
•Stimulated whole salivary flow rate of >= 0.1 mL/min;

Inclusion criteria specific for Cohort 1;
•ESSDAI >= 5 within the 8 predefined organ domains;
•ESSPRI score of >=5;

Inclusion criteria specific for Cohort 2;
•ESSDAI < 5 within 8 domains scored for inclusion criterion #7 Cohort 1;
•ESSPRI fatigue subscore >= 5 or ESSPRI dryness subscore >= 5;

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

•Sjögren's Syndrome overlap syndromes where another autoimmune rheumatic
disease constitutes the principle illness;
•Use of other investigational drugs;
•Use of B cell depleting therapies within 6 months prior to randomization,
abatacept or any other immunosuppressants unless specifically allowed in the
protocol;
•Use of steroids at dose > 10 mg/day;
•Uncontrolled ocular rosacea (affecting the eye adnexa), posterior blepharitis
or Meibomian gland disease (this criterion applies only to patients considered
for Cohort 2);
•Active viral, bacterial or other infections requiring systemic treatment;
•Receipt of live/attenuated vaccine within a 2-month period prior to
randomization, during treatment and for at least 14 weeks thereafter;
•Chronic infection with hepatitis B (HBV) or hepatitis C (HCV);
- Evidence of active CMV infection in the form of a positive serology for
CMV IgM (in the absence or presence of positive CMV IgG) and/or
quantifiable CMV DNA by PCR at screening.
•Evidence of active tuberculosis (TB) infection.

Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objectives of the study are defined separately for each cohort.<br /><br>Cohort 1:<br /><br>To demonstrate a dose-response of CFZ533 (iscalimab) based on change in ESSDAI<br /><br>from baseline at Week 24.<br /><br>Cohort 2:<br /><br>To estimate the effect of CFZ533 (iscalimab) 600 mg s.c. on the change in<br /><br>ESSPRI at Week 24.</p><br>