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PD of VAY736 in Patients With Primary Sjögren's Syndrome (CVAY736X2201)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02149420
First Posted: May 29, 2014
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study is designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of a single intravenous infusion of VAY7346 monoclonal antibody in pSS patients

Condition Intervention Phase
Primary Sjögren's Syndrome Drug: VAY736 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single Dose, Double-blind, Placebo-controlled, Parallel Study to Assess the Pharmacodynamics, Pharmacokinetics and Safety and Tolerability of VAY736 in Patients With Primary Sjögren's Syndrome

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Change in EULAR Sjögren's syndrome disease activity index (ESSDAI) [ Time Frame: Baseline, week 12 ]
    The effect of VAY736 on clinical disease activity will be measured by the change in ESSDAI (EULAR Sjögren's syndrome disease activity index) between baseline and week 12. The ESSDAI is a questionnaire containing 12 organ-specific domains.


Secondary Outcome Measures:
  • Change in EULAR Sjögren's Syndrome Patient Response Index (ESSPRI) [ Time Frame: Baseline, week 12 ]
    The ESSPRI is a patient self-reported outcome measure (questionnaires) to assess patient's disease status (e.g. pain, emotional/social/physical functioning, mental health, fatigue).

  • Change in Short Form (36) Health Survey (SF-36) [ Time Frame: Baseline, week 12 ]
    The SF-36 is a patient self-reported outcome measure (questionnaires) to assess patient's disease status and burden, e.g. pain, emotional/social/physical functioning, mental health.

  • Change in Multidimensional Fatigue Inventory (MFI) [ Time Frame: Baseline, week 12 ]
    The MFI is a patient self-reported outcome measure (questionnaires) to assess fatigue.

  • Change in the physician's global assessment by means of Visual Analog Scale (VAS) [ Time Frame: Baseline, week 12 ]
    The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm).

  • Change in the patient's global assessment by means of Visual Analog Scale (VAS) [ Time Frame: Baseline, week 12 ]
    The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm).

  • VAY736 serum concentration [ Time Frame: 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks. ]
    The concentration of VAY736 will be measured in the serum. Descriptive statistics will include maximum serum concentration, time to reach maximum concentration, area under the concentration curve, half-life, plasma clearance.


Enrollment: 27
Study Start Date: May 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VAY736 dose 1 Drug: VAY736
Experimental: VAY736 Dose 2 Drug: VAY736
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Information from the National Library of Medicine

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

INCLUSION CRITERIA:

  • Fulfilled revised European US consensus criteria for pSS
  • ESSDAI value ≥ 6
  • Elevated serum titers at screening of ANA (≥ 1:160)
  • Seropositive at screening for anti-SSA and/or anti-SSB antibodies
  • Stimulated whole salivary flow rate at screening of > 0 mL/min

EXCLUSION CRITERIA:

- Prior or previous use of (specific dosages and intervals prior to study start may apply): B-cell depleting therapy (e.g., rituximab), Prednisone, anti-BAFF mAb, CTLA4-Fc Ig (abatacept), anti-TNF-α mAb, cyclophosphamide, azathioprine and medications known to cause dry mouth.

Hydroxychloroquine or methotrexate in a consistent dose for ≥ 3 months prior to randomization is allowed

  • Active or recent history of clinically significant infection
  • Vaccination within 2 month prior to study
  • History of primary or secondary immunodeficiency
  • Other protocol-defined inclusion/exclusion criteria may apply.
  Contacts and Locations
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): NCT02149420


Locations
Germany
Novartis Investigative Site
Berlin, Germany, 10117
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02149420     History of Changes
Other Study ID Numbers: CVAY736X2201
2013-000250-22 ( EudraCT Number )
First Submitted: September 9, 2013
First Posted: May 29, 2014
Last Update Posted: March 15, 2017
Last Verified: March 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
primary Sjögren's syndrome, pharmacodynamics

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