Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome

Primary Sjögren's Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02291029
• Other study ID #: CCFZ533X2203
• Status: Completed
• Phase: Phase 2
• Start date: October 22, 2014
• Est. completion date: June 29, 2018

Study information

• Verified date: July 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 29, 2018
• Est. primary completion date: June 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Primary Sjögren's Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

Drug:
• CFZ533 active - Cohort 1
multiple doses of CFZ533 s.c. injection
• CFZ533 placebo- Cohort 1
multiple doses of placebo s.c. injection
• CFZ533 active - Cohort 2
multiple doses of CFZ533 intravenous infusion
• CFZ533 placebo - Cohort 2
multiple doses of placebo intravenous infusion
• CFZ533 active -Cohort 3
multiple doses of CFZ533 s.c. injection
• CFZ533 active - Cohort 3
Single dose of CFZ533 i.v. infusion and multiple doses of CFZ533 s.c. injection

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Berlin
Hungary	Novartis Investigative Site	Debrecen
Switzerland	Novartis Investigative Site	Basel
United Kingdom	Novartis Investigative Site	Edgbaston	Birmingham
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Newcastle upon Tyne
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Duncansville	Pennsylvania
United States	Novartis Investigative Site	Mineola	New York

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany,  Hungary,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)	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.	Baseline and Week 12
Secondary	Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI)	The ESSPRI is a patient self-reported outcome measure to assess dryness, limb pain, fatigue and mental fatigue, where each of the domains normally reported as 0 (not at all) to 10 (extremely severe). The final ESSPRI score is the average of three: dryness, pain and fatigue. A reduction from baseline indicates the improvement of symptoms.	Baseline and Week 12
Secondary	Change From Baseline in Physician Global Assessment of the Patient's Overall Disease Activity (VAS)	The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm).	Baseline and Week 12
Secondary	Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS)	The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm).	Baseline and Week 12
Secondary	Change From Baseline in Short Form (36) Health Survey (SF-36) Physical Component Score	The SF-36 is a 36-item, patient self-reported outcome measure (questionnaires) of patient health. The outcome of the questionnaires in eight scales results in two summary scores, physical component and mental component, both ranging from 0 - 100. An increase from baseline in either component summary score indicates reduced disease burden.	Baseline and Week 12
Secondary	Change From Baseline in Short Form (36) Health Survey (SF-36) Mental Component Score	The SF-36 is a 36-item, patient self-reported outcome measure (questionnaires) of patient health. The outcome of the questionnaires in eight scales results in two summary scores, physical component and mental component, both ranging from 0 - 100. An increase from baseline in either component summary score indicates reduced disease burden.	Baseline and Week 12
Secondary	Change From Baseline in Multidimensional Fatigue Inventory (MFI)	The MFI is a patient self-reported outcome measure (questionnaires) to assess fatigue covering the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Each dimension has a possible range from 4-20. The reported total score has a range from 20-100. A reduction from baseline in MFI indicates improvement.	Baseline and Week 12

External Links

•   A Plain Language Trial Summary is available on novartisclinicatrials.com