Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome
NCT ID: NCT02291029
Last Updated: 2021-01-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
69 participants
INTERVENTIONAL
2014-10-22
2018-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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CFZ533 active- Cohort 2
multiple doses of CFZ533 intravenous infusion
CFZ533 active - Cohort 2
multiple doses of CFZ533 intravenous infusion
CFZ533 placebo- Cohort 2
multiple doses of placebo intravenous infusion
CFZ533 placebo - Cohort 2
multiple doses of placebo intravenous infusion
CFZ533 active - Cohort 1
multiple doses of CFZ533 s.c. injection
CFZ533 active - Cohort 1
multiple doses of CFZ533 s.c. injection
CFZ533 placebo - Cohort 1
multiple doses of placebo s.c. injection
CFZ533 placebo- Cohort 1
multiple doses of placebo s.c. injection
CFZ533 Treatment Arm 1 - Cohort 3
multiple doses of CFZ533 s.c. injection
CFZ533 active -Cohort 3
multiple doses of CFZ533 s.c. injection
CFZ533 Treatment Arm 2 - Cohort 3
Single dose of CFZ533 i.v. infusion and 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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* ESSDAI score ≥ 6
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Mineola, New York, United States
Novartis Investigative Site
Duncansville, Pennsylvania, United States
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Debrecen, , Hungary
Novartis Investigative Site
Basel, , Switzerland
Novartis Investigative Site
Edgbaston, Birmingham, United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Newcastle upon Tyne, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on novartisclinicatrials.com
Other Identifiers
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CCFZ533X2203
Identifier Type: -
Identifier Source: org_study_id
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