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

Primary Purpose

Primary Sjogren Syndrome

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

VAY736

Placebo

About this trial

This is an interventional treatment trial for Primary Sjogren Syndrome focused on measuring Sjogren, VAY736, ianalumab, pSS

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

VAY736 dose 1

VAY736 dose 2

VAY736 dose 3

Placebo

Arm Description

VAY736 low

VAY736 medium

VAY736 high

Placebo control

Outcomes

Primary Outcome Measures

Change in multi-dimensional disease activity

Dose response measured by change multi-dimensional disease activity as assessed by the physician

Secondary Outcome Measures

Change in patient-reported disease activity measures

Dose response measured by change in patient-reported disease activity measures

Change in quality of life measure by PRO

Change in quality of life measure by patient reported outcome (PRO)

Change in salivary gland function measure by flow rate

salivary gland function measure by flow rate

Incidence of Adverse events and Serious Adverse Events

Number of participants with adverse events

Full Information

NCT ID

NCT02962895

First Posted

November 3, 2016

Last Updated

January 20, 2022

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02962895

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

June 27, 2017 (Actual)

Primary Completion Date

June 30, 2020 (Actual)

Study Completion Date

September 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Sjogren Syndrome

Keywords

Sjogren, VAY736, ianalumab, pSS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

192 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VAY736 dose 1

Arm Type

Experimental

Arm Description

VAY736 low

Arm Title

VAY736 dose 2

Arm Type

Experimental

Arm Description

VAY736 medium

Arm Title

VAY736 dose 3

Arm Type

Experimental

Arm Description

VAY736 high

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo control

Intervention Type

Biological

Intervention Name(s)

VAY736

Intervention Description

VAY736

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo control

Primary Outcome Measure Information:

Title

Change in multi-dimensional disease activity

Description

Dose response measured by change multi-dimensional disease activity as assessed by the physician

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Change in patient-reported disease activity measures

Description

Dose response measured by change in patient-reported disease activity measures

Time Frame

24 weeks

Title

Change in quality of life measure by PRO

Description

Change in quality of life measure by patient reported outcome (PRO)

Time Frame

24 weeks

Title

Change in salivary gland function measure by flow rate

Description

salivary gland function measure by flow rate

Time Frame

24 weeks

Title

Incidence of Adverse events and Serious Adverse Events

Description

Number of participants with adverse events

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Novartis Investigative Site

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

Novartis Investigative Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Novartis Investigative Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Novartis Investigative Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14618

Country

United States

Facility Name

Novartis Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Novartis Investigative Site

City

Wexford

State/Province

Pennsylvania

ZIP/Postal Code

15090

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Novartis Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Bs As

State/Province

Buenos Aires

ZIP/Postal Code

C1055AAF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

ZIP/Postal Code

1117

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5016KEH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Santiago

ZIP/Postal Code

7500710

Country

Chile

Facility Name

Novartis Investigative Site

City

Santiago

ZIP/Postal Code

8207257

Country

Chile

Facility Name

Novartis Investigative Site

City

Brest

ZIP/Postal Code

29200

Country

France

Facility Name

Novartis Investigative Site

City

Lille

ZIP/Postal Code

59000

Country

France

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81377

Country

Germany

Facility Name

Novartis Investigative Site

City

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

H-1097

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Novartis Investigative Site

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Novartis Investigative Site

City

Rozzano

State/Province

ZIP/Postal Code

20089

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00161

Country

Italy

Facility Name

Novartis Investigative Site

City

Udine

State/Province

ZIP/Postal Code

33100

Country

Italy

Facility Name

Novartis Investigative Site

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

457 8510

Country

Japan

Facility Name

Novartis Investigative Site

City

Sasebo-city

State/Province

Nagasaki

ZIP/Postal Code

857-1165

Country

Japan

Facility Name

Novartis Investigative Site

City

Itabashi-ku

State/Province

Tokyo

ZIP/Postal Code

173-8610

Country

Japan

Facility Name

Novartis Investigative Site

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

160 8582

Country

Japan

Facility Name

Novartis Investigative Site

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Lublin

ZIP/Postal Code

20-954

Country

Poland

Facility Name

Novartis Investigative Site

City

Almada

ZIP/Postal Code

2801 951

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1050-034

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4099 001

Country

Portugal

Facility Name

Novartis Investigative Site

City

Brasov

ZIP/Postal Code

500283

Country

Romania

Facility Name

Novartis Investigative Site

City

Cluj Napoca

ZIP/Postal Code

400006

Country

Romania

Facility Name

Novartis Investigative Site

City

Ekaterinburg

ZIP/Postal Code

620028

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Orenburg

ZIP/Postal Code

460000

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

190068

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

195257

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Vigo

State/Province

Pontevedra

ZIP/Postal Code

36200

Country

Spain

Facility Name

Novartis Investigative Site

City

La Laguna

State/Province

Santa Cruz De Tenerife

ZIP/Postal Code

38320

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Novartis Investigative Site

City

Kaohsiung

ZIP/Postal Code

81346

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

11490

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Westcliff-on-Sea

State/Province

Essex

ZIP/Postal Code

SS0 0RY

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Liverpool

ZIP/Postal Code

L9 7AL

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing 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

Citations:

PubMed Identifier

34861168

Citation

Bowman SJ, Fox R, Dorner T, Mariette X, Papas A, Grader-Beck T, Fisher BA, Barcelos F, De Vita S, Schulze-Koops H, Moots RJ, Junge G, Woznicki JN, Sopala MA, Luo WL, Hueber W. Safety and efficacy of subcutaneous ianalumab (VAY736) in patients with primary Sjogren's syndrome: a randomised, double-blind, placebo-controlled, phase 2b dose-finding trial. Lancet. 2022 Jan 8;399(10320):161-171. doi: 10.1016/S0140-6736(21)02251-0. Epub 2021 Nov 30.

Results Reference

derived

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

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

Primary Sjogren Syndrome

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial