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Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02962895
Recruitment Status : Recruiting
First Posted : November 15, 2016
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
This study will determine the dose-response relationship of VAY736 for key efficacy and safety parameters

Condition or disease Intervention/treatment Phase
Primary Sjogren's Syndrome Biological: VAY736 Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Study of Safety and Efficacy of Multiple VAY736 Doses in Patients With Moderate to Severe Primary Sjogren's Syndrome (pSS)
Actual Study Start Date : June 27, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: VAY736 dose 1
VAY736 low
 Biological: VAY736
VAY736
Experimental: VAY736 dose 2
VAY736 medium
 Biological: VAY736
VAY736
Experimental: VAY736 dose 3
VAY736 high
 Biological: VAY736
VAY736
Placebo Comparator: Placebo
Placebo control
 Other: Placebo
Placebo control


Outcome Measures
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Primary Outcome Measures :
  1. Dose response [ Time Frame: 24 weeks ]
    Dose response measured by change multi-dimensional disease activity as assessed by the physician


Secondary Outcome Measures :
  1. Dose response [ Time Frame: 24 weeks ]
    Dose response measured by change in patient-reported disease activity measures

  2. Quality of Life [ Time Frame: 24 weeks ]
    Change in quality of life measure by PRO

  3. Salivary gland function [ Time Frame: 24 weeks ]
    Change in salivary gland function measure by flow rate

  4. Safety [ Time Frame: 24 weeks ]
    Incidence of Adverse events and Serious Adverse Events


Eligibility Criteria
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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:

  • Fulfilled revised American European Consensus Group criteria for pSS
  • Seropositive at screening for anti-Ro/SSA antibodies
  • Screening ESSDAI value >=6 scored from 7 domains: articular, cutaneous, glandular, lymphoadenopathy, constitutional, biologic and hematologic.

Exclusion Criteria:

  • Secondary Sjogren's syndrome
  • Use of other investigational drugs
  • Active viral, bacterial or other infections
  • Positive hepatitis B, hepatitis C, HIV or tuberculosis test results at screening
Contacts and Locations
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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): NCT02962895


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

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Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02962895     History of Changes
Other Study ID Numbers: CVAY736A2201
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Sjogren, VAY736, ianalumab
Additional relevant MeSH terms:
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Sjogren's Syndrome
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