This study will evaluate safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
273
Change in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score from baseline at 24 weeks as compared to placebo
Cohort 1 - Efficacy
Time frame: 24 weeks
Change in EULAR Sjögren Syndrome Patient Reported Index (ESSPRI) score from baseline at 24 weeks as compared to placebo.
Cohort 2 - Efficacy
Time frame: 24 weeks
Change from baseline in ESSPRI at Week 24
Cohort 1 - Efficacy (Patient Reported Outcomes)
Time frame: 24 weeks
Change from baseline in score of Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire at Week 24
Cohort 1\&2 - Efficacy (Patient Reported Outcomes)
Time frame: 24 weeks
Change from baseline in Physician Global Assessment (PhGA) at Week 24
Cohort 1\&2 - Efficacy (Clinical Outcome Measures)
Time frame: 24 weeks
Change from baseline in ESSDAI at Week 24
Cohort 2 - Efficacy (Clinical Outcome Measures)
Time frame: 24 weeks
Proportion of subjects with at least 12 points improvement measured by score of Impact of Dry Eye on Everyday Life (IDEEL) questionnaire symptom bother module at Week 24.
Cohort 2 - Efficacy (Patient Reported Outcomes)
Time frame: 24 weeks
Incidence of adverse events (AEs), serious adverse events (SAEs) from baseline to Week 24 and from week 24 to the end of study
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Novartis Investigative Site
Duluth, Georgia, United States
Novartis Investigative Site
Indianapolis, Indiana, United States
Novartis Investigative Site
Baton Rouge, Louisiana, United States
Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Mineola, New York, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, United States
Novartis Investigative Site
Madison, Wisconsin, United States
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires, Argentina
Novartis Investigative Site
CABA, Argentina
...and 61 more locations
Cohort 1\&2 - Safety
Time frame: 60 weeks
Serum Free Light Chain (FLC) levels at analysis visit up to end of study
Cohort 1\&2 - Biomarkers (1)
Time frame: 60 weeks
Immunoglobulin IgG and IgM levels at analysis visits up to end of study
Cohort 1\&2 - Biomarkers (2)
Time frame: 60 weeks
Percent change from baseline in plasma CXCL-13 levels at analysis visits up to end of study
Cohort 1\&2 - Biomarkers (3) Chemokine (C-X-C motif) ligand 13 (CXCL13), also known as B lymphocyte chemoattractant (BLC) or B cell-attracting chemokine 1 (BCA-1), is a protein ligand that in humans is encoded by the CXCL13 gene.
Time frame: 60 weeks