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

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ClinicalTrials.gov Identifier: NCT02291029
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will 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)

Condition or disease Intervention/treatment Phase
Primary Sjögren's Syndrome Drug: CFZ533 active - Cohort 1 Drug: CFZ533 placebo- Cohort 1 Drug: CFZ533 active - Cohort 2 Drug: CFZ533 placebo - Cohort 2 Drug: CFZ533 active -Cohort 3 Drug: CFZ533 active - Cohort 3 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : October 22, 2014
Actual Primary Completion Date : June 29, 2018
Actual Study Completion Date : June 29, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CFZ533 active- Cohort 2
multiple doses of CFZ533 intravenous infusion
Drug: CFZ533 active - Cohort 2
multiple doses of CFZ533 intravenous infusion

Placebo Comparator: CFZ533 placebo- Cohort 2
multiple doses of placebo intravenous infusion
Drug: CFZ533 placebo - Cohort 2
multiple doses of placebo intravenous infusion

Experimental: CFZ533 active - Cohort 1
multiple doses of CFZ533 s.c. injection
Drug: CFZ533 active - Cohort 1
multiple doses of CFZ533 s.c. injection

Placebo Comparator: CFZ533 placebo - Cohort 1
multiple doses of placebo s.c. injection
Drug: CFZ533 placebo- Cohort 1
multiple doses of placebo s.c. injection

Experimental: CFZ533 Treatment Arm 1 - Cohort 3
multiple doses of CFZ533 s.c. injection
Drug: CFZ533 active -Cohort 3
multiple doses of CFZ533 s.c. injection

Experimental: CFZ533 Treatment Arm 2 - Cohort 3
Single dose of CFZ533 i.v. infusion and multiple doses of CFZ533 s.c. injection
Drug: CFZ533 active - Cohort 3
Single dose of CFZ533 i.v. infusion and multiple doses of CFZ533 s.c. injection




Primary Outcome Measures :
  1. EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) [ Time Frame: 12 weeks ]
    The changes in an EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) after 12 weeks treatment will be analysed and compared between the active treatment and placebo groups.


Secondary Outcome Measures :
  1. EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI) [ Time Frame: 12 weeks ]
    To assess the changes of ESSPRI between baseline and Week 13

  2. Physician global assessment of the patient's overall disease activity (VAS) [ Time Frame: 12 weeks ]
    To assess the changes of physician global assessment of the patient's overall disease activity (VAS) between baseline and Week 13

  3. Patient's global assessment of their disease activity (VAS) [ Time Frame: 12 weeks ]
    To assess the changes of patient's global assessment of their disease activity (VAS) beween baseline and Week 13

  4. Short Form (36) Health Survey (SF-36) [ Time Frame: 12 weeks ]
    To assess the changes of SF-36 between baseline and Week 13

  5. Multidimensional Fatigue Inventory (MFI) [ Time Frame: 12 weeks ]
    To assess the changes of MFI between baseline and Week 13



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291029


Locations
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United States, Massachusetts
Novartis Investigative Site
Boston, Massachusetts, United States, 02111
United States, New York
Novartis Investigative Site
Mineola, New York, United States, 11501
United States, Pennsylvania
Novartis Investigative Site
Duncansville, Pennsylvania, United States, 16635
Germany
Novartis Investigative Site
Berlin, Germany, 10117
Hungary
Novartis Investigative Site
Debrecen, Hungary, 4032
Switzerland
Novartis Investigative Site
Basel, Switzerland, 4031
United Kingdom
Novartis Investigative Site
Edgbaston, Birmingham, United Kingdom, B15 2WB
Novartis Investigative Site
London, United Kingdom, EC14 7BE
Novartis Investigative Site
London, United Kingdom, WC1E 6HX
Novartis Investigative Site
Newcastle upon Tyne, United Kingdom, NE2 4HH
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02291029     History of Changes
Other Study ID Numbers: CCFZ533X2203
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Sjögren's syndrome, CFZ533, ESSDAI

Additional relevant MeSH terms:
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Syndrome
Sjogren's Syndrome
Dry Eye Syndromes
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases