Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome
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
1 other identifier
interventional
69
5 countries
9
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2014
Typical duration for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 22, 2014
CompletedFirst Submitted
Initial submission to the registry
November 4, 2014
CompletedFirst Posted
Study publicly available on registry
November 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2018
CompletedResults Posted
Study results publicly available
August 14, 2019
CompletedJanuary 5, 2021
July 1, 2019
3.7 years
November 4, 2014
June 28, 2019
December 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (6)
CFZ533 active- Cohort 2
EXPERIMENTALmultiple doses of CFZ533 intravenous infusion
CFZ533 placebo- Cohort 2
PLACEBO COMPARATORmultiple doses of placebo intravenous infusion
CFZ533 active - Cohort 1
EXPERIMENTALmultiple doses of CFZ533 s.c. injection
CFZ533 placebo - Cohort 1
PLACEBO COMPARATORmultiple doses of placebo s.c. injection
CFZ533 Treatment Arm 1 - Cohort 3
EXPERIMENTALmultiple doses of CFZ533 s.c. injection
CFZ533 Treatment Arm 2 - Cohort 3
EXPERIMENTALSingle dose of CFZ533 i.v. infusion and multiple doses of CFZ533 s.c. injection
Interventions
Single dose of CFZ533 i.v. infusion and multiple doses of CFZ533 s.c. injection
Eligibility Criteria
You may qualify if:
- Diagnosis of primary Sjögren's syndrome
- ESSDAI score ≥ 6
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Novartis Investigative Site
Boston, Massachusetts, 02111, United States
Novartis Investigative Site
Mineola, New York, 11501, United States
Novartis Investigative Site
Duncansville, Pennsylvania, 16635, United States
Novartis Investigative Site
Berlin, 10117, Germany
Novartis Investigative Site
Debrecen, 4032, Hungary
Novartis Investigative Site
Basel, 4031, Switzerland
Novartis Investigative Site
Edgbaston, Birmingham, B15 2WB, United Kingdom
Novartis Investigative Site
London, EC14 7BE, United Kingdom
Novartis Investigative Site
Newcastle upon Tyne, NE2 4HH, United Kingdom
Related Publications (1)
Fisher BA, Szanto A, Ng WF, Bombardieri M, Posch MG, Papas AS, Farag AM, Daikeler T, Bannert B, Kyburz D, Kivitz AJ, Carsons SE, Isenberg DA, Barone F, Bowman SJ, Espie P, Floch D, Dupuy C, Ren X, Faerber PM, Wright AM, Hockey HU, Rotte M, Milojevic J, Avrameas A, Valentin MA, Rush JS, Gergely P. Assessment of the anti-CD40 antibody iscalimab in patients with primary Sjogren's syndrome: a multicentre, randomised, double-blind, placebo-controlled, proof-of-concept study. Lancet Rheumatol. 2020 Mar;2(3):e142-e152. doi: 10.1016/S2665-9913(19)30135-3. Epub 2020 Jan 23.
PMID: 38263652DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2014
First Posted
November 14, 2014
Study Start
October 22, 2014
Primary Completion
June 29, 2018
Study Completion
June 29, 2018
Last Updated
January 5, 2021
Results First Posted
August 14, 2019
Record last verified: 2019-07