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PD of VAY736 in Patients With Primary Sjögren's Syndrome | Clinical Trials | Clareo Health

COMPLETEDPHASE2

PD of VAY736 in Patients With Primary Sjögren's Syndrome

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

NCT02149420•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study was designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of a single intravenous infusion of VAY7346 monoclonal antibody in pSS patients

Detailed Description

Patients were enrolled in 2 sequential cohorts: Cohort 1: 6 patients received 3 mg/kg or Placebo (2:1 ratio) Cohort 2: 21 patients received 10 mg/kg, 3 mg/kg or Placebo (6:1:3 ratio) At week 24 the blind was broken to assess continuation in the trial: * If a patient received VAY736 and their B cell recovery was demonstrated at Week 24, then patients completed the trial. * If a patient received VAY736 and their B cell recovery was NOT demonstrated at Week 24, then patients were followed up until B cell recovery was demonstrated * If a patient received placebo, they were offered the option of receiving open-label VAY736 (10 mg/kg) in a separate treatment arm.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Novartis Investigative Site

Berlin, Germany

Key Dates

Start Date

May 23, 2014

Primary Completion Date

February 7, 2018

Completion Date

February 7, 2018

Last Updated

October 4, 2021

Enrollment

ACTUAL participants

Conditions

Primary Sjögren's Syndrome

Interventions

VAY736

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 4, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PD of VAY736 in Patients With Primary Sjögren's Syndrome

Inclusion Criteria

Exclusion Criteria

Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome

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