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

Primary Sjogren Syndrome Clinical Trial

Official title:

Study of Safety and Efficacy of Multiple VAY736 Doses in Patients With Moderate to Severe Primary Sjogren's Syndrome (pSS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02962895
• Other study ID #: CVAY736A2201
• Status: Completed
• Phase: Phase 2
• Start date: June 27, 2017
• Est. completion date: September 23, 2021

Study information

• Verified date: January 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will determine the dose-response relationship of VAY736 for key efficacy and safety parameters

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: September 23, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Primary Sjogren Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

Biological:
• VAY736
VAY736

Other:
• Placebo
Placebo control

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Caba
Argentina	Novartis Investigative Site	Ciudad Autonoma de Bs As	Buenos Aires
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Austria	Novartis Investigative Site	Graz
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Leuven
Chile	Novartis Investigative Site	Santiago
Chile	Novartis Investigative Site	Santiago
France	Novartis Investigative Site	Brest
France	Novartis Investigative Site	Lille
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Wuerzburg
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Szeged
Israel	Novartis Investigative Site	Ramat Gan
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Rozzano	MI
Italy	Novartis Investigative Site	Udine	UD
Japan	Novartis Investigative Site	Itabashi-ku	Tokyo
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Sasebo-city	Nagasaki
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Netherlands	Novartis Investigative Site	Rotterdam
Poland	Novartis Investigative Site	Lublin
Portugal	Novartis Investigative Site	Almada
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Porto
Romania	Novartis Investigative Site	Brasov
Romania	Novartis Investigative Site	Cluj Napoca
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Orenburg
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	St Petersburg
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	La Laguna	Santa Cruz De Tenerife
Spain	Novartis Investigative Site	Vigo	Pontevedra
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taipei
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Liverpool
United Kingdom	Novartis Investigative Site	Westcliff-on-Sea	Essex
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Plantation	Florida
United States	Novartis Investigative Site	Rochester	New York
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	Wexford	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Chile,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Netherlands,  Poland,  Portugal,  Romania,  Russian Federation,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in multi-dimensional disease activity	Dose response measured by change multi-dimensional disease activity as assessed by the physician	24 weeks
Secondary	Change in patient-reported disease activity measures	Dose response measured by change in patient-reported disease activity measures	24 weeks
Secondary	Change in quality of life measure by PRO	Change in quality of life measure by patient reported outcome (PRO)	24 weeks
Secondary	Change in salivary gland function measure by flow rate	salivary gland function measure by flow rate	24 weeks
Secondary	Incidence of Adverse events and Serious Adverse Events	Number of participants with adverse events	24 weeks