Overview

This trial is active, not recruiting.

Condition primary sjögren's syndrome
Treatments vay736, placebo
Phase phase 2
Sponsor Novartis Pharmaceuticals
Start date May 2014
End date June 2017
Trial size 27 participants
Trial identifier NCT02149420, 2013-000250-22, CVAY736X2201

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacodynamics study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
vay736
(Experimental)
vay736
(Placebo Comparator)
placebo

Primary Outcomes

Measure
Change in EULAR Sjögren's syndrome disease activity index (ESSDAI)
time frame: Baseline, week 12

Secondary Outcomes

Measure
Change in EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)
time frame: Baseline, week 12
Change in Short Form (36) Health Survey (SF-36)
time frame: Baseline, week 12
Change in Multidimensional Fatigue Inventory (MFI)
time frame: Baseline, week 12
Change in the physician's global assessment by means of Visual Analog Scale (VAS)
time frame: Baseline, week 12
Change in the patient's global assessment by means of Visual Analog Scale (VAS)
time frame: Baseline, week 12
VAY736 serum concentration
time frame: 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Novartis.