A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CFZ533 in Patients With Primary Sjögren's Syndrome
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)
Study Overview
Brief Summary
This study did evaluate the safety,tolerability and preliminary therapeutic efficacy of multiple doses of intravenous infusion of CFZ533 monoclonal antibody in patients with primary Sjögren's syndrome(pSS)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of primary Sjögren's syndrome
- •ESSDAI score ≥ 6
Exclusion Criteria
- •Secondary Sjögren's syndrome
- •Receiving cyclosphosphamide, corticosteroid bolus with dose over 1 mg/kg, rituximab, belimunab, other immunosuppressives.
- •At significant risk for thromboembolic event
- •Clinically significant systemic infection
- •Significant elevated risk for infection
Arms & Interventions
CFZ533 active- Cohort 2
multiple doses of CFZ533 intravenous infusion
Intervention: CFZ533 active - Cohort 2 (Drug)
CFZ533 placebo- Cohort 2
multiple doses of placebo intravenous infusion
Intervention: CFZ533 placebo - Cohort 2 (Drug)
CFZ533 active - Cohort 1
multiple doses of CFZ533 s.c. injection
Intervention: CFZ533 active - Cohort 1 (Drug)
CFZ533 placebo - Cohort 1
multiple doses of placebo s.c. injection
Intervention: CFZ533 placebo- Cohort 1 (Drug)
CFZ533 Treatment Arm 1 - Cohort 3
multiple doses of CFZ533 s.c. injection
Intervention: CFZ533 active -Cohort 3 (Drug)
CFZ533 Treatment Arm 2 - Cohort 3
Single dose of CFZ533 i.v. infusion and multiple doses of CFZ533 s.c. injection
Intervention: CFZ533 active - Cohort 3 (Drug)
Outcomes
Primary Outcomes
Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)
Time Frame: Baseline and Week 12
The effect of CFZ533 on clinical disease activity was measured by the change in ESSDAI (EULAR Sjögren's syndrome disease activity index) between baseline and week 12. The instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score (range 0-123). A reduction from baseline indicates improvement in patients.
Secondary Outcomes
- Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI)(Baseline and Week 12)
- Change From Baseline in Physician Global Assessment of the Patient's Overall Disease Activity (VAS)(Baseline and Week 12)
- Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS)(Baseline and Week 12)
- Change From Baseline in Short Form (36) Health Survey (SF-36) Physical Component Score(Baseline and Week 12)
- Change From Baseline in Short Form (36) Health Survey (SF-36) Mental Component Score(Baseline and Week 12)
- Change From Baseline in Multidimensional Fatigue Inventory (MFI)(Baseline and Week 12)