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

NCT02962895 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CVAY736A2201
• Study Type: interventional
• Target: 190
• Locations: 19 countries
• Sites: 56

Brief Summary

The purpose of this study was to determine the dose-response relationship of VAY736 for key efficacy and safety parameters

Conditions

Primary Sjogren Syndrome

Keywords

Sjogren; VAY736; ianalumab; pSS

Outcome Measures

Primary Outcomes (1)

• Least Squares Mean Change From Baseline in ESSDAI Score at Week 24

  The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score ranging 0-123. Higher scores on the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) scale are associated with poorer health states. A negative change from baseline indicates improvement in disease status.

  Baseline, Week 24

Secondary Outcomes (14)

• Least Squares Mean Change From Baseline in ESSDAI Score at Weeks 4, 8, 12, and 16

  Baseline, Week 4, Week 8, Week 12, Week 16

• Least Squares Mean Change From Baseline in ESSPRI Score at Week 24

  Baseline, Week 24

• Least Squares Mean Change From Baseline in ESSPRI Score at Weeks 4, 8, 12 and 16

  Baseline, Week 4, Week 8, Week 12, Week 16

• Least Squares Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) Score Over 24 Weeks

  Baseline, Week 24

• Least Squares Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) Score at Weeks 4, 8, 12 and 16

  Baseline, Weeks 4, 8, 12 and 16

Study Arms (4)

VAY736 dose 1 - 5mg

EXPERIMENTAL

VAY736 low

Biological: VAY736

VAY736 dose 2 - 50mg

EXPERIMENTAL

VAY736 medium

Biological: VAY736

VAY736 dose 3 - 300 mg

EXPERIMENTAL

VAY736 high

Biological: VAY736

Placebo

PLACEBO COMPARATOR

Placebo control

Other: Placebo

Interventions

VAY736 BIOLOGICAL

VAY736

Also known as: Ianalumab

VAY736 dose 1 - 5mg; VAY736 dose 2 - 50mg; VAY736 dose 3 - 300 mg

Placebo OTHER

Placebo control

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (56)

Integral Rheumatology and Immunology Specialists IRIS

Plantation, Florida, 33324, United States

Location

Indiana Univ School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

The John Hopkins Jerome L Greene Sjogren

Baltimore, Maryland, 21224, United States

Location

Tufts School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

AAIR Research Center

Rochester, New York, 14618, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Advanced Rheumatology and Arthritis Wellness Center

Wexford, Pennsylvania, 15090, United States

Location

Baylor College Of Medicine

Houston, Texas, 77030, United States

Location

First Outpatient Research Unit

San Antonio, Texas, 78229, United States

Location

Novartis Investigative Site

Ciudad Autonoma de Bs As, Buenos Aires, C1055AAF, Argentina

Location

Novartis Investigative Site

CABA, 1117, Argentina

Location

Novartis Investigative Site

Córdoba, 5000, Argentina

Location

Novartis Investigative Site

Córdoba, X5016KEH, Argentina

Location

Novartis Investigative Site

Graz, 8036, Austria

Location

Novartis Investigative Site

Brussels, 1070, Belgium

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Santiago, 7500710, Chile

Location

Novartis Investigative Site

Santiago, 8207257, Chile

Location

Novartis Investigative Site

Brest, 29200, France

Location

Novartis Investigative Site

Lille, 59037, France

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany

Location

Novartis Investigative Site

München, 81377, Germany

Location

Novartis Investigative Site

Würzburg, 97080, Germany

Location

Novartis Investigative Site

Budapest, H-1097, Hungary

Location

Novartis Investigative Site

Szeged, 6720, Hungary

Location

Novartis Investigative Site

Ramat Gan, 52621, Israel

Location

Novartis Investigative Site

Rozzano, MI, 20089, Italy

Location

Novartis Investigative Site

Roma, RM, 00161, Italy

Location

Novartis Investigative Site

Udine, UD, 33100, Italy

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 457 8510, Japan

Location

Novartis Investigative Site

Sasebo, Nagasaki, 857-1165, Japan

Location

Novartis Investigative Site

Itabashi-ku, Tokyo, 173-8610, Japan

Location

Novartis Investigative Site

Shinjuku-ku, Tokyo, 160 8582, Japan

Location

Novartis Investigative Site

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Novartis Investigative Site

Lublin, 20-954, Poland

Location

Novartis Investigative Site

Almada, 2801 951, Portugal

Location

Novartis Investigative Site

Lisbon, 1050-034, Portugal

Location

Novartis Investigative Site

Lisbon, 1649 035, Portugal

Location

Novartis Investigative Site

Porto, 4099-001, Portugal

Location

Novartis Investigative Site

Brasov, 500283, Romania

Location

Novartis Investigative Site

Cluj-Napoca, 400006, Romania

Location

Novartis Investigative Site

Moscow, 115522, Russia

Location

Novartis Investigative Site

Orenburg, 460000, Russia

Location

Novartis Investigative Site

Saint Petersburg, 195257, Russia

Location

Novartis Investigative Site

Yekaterinburg, 620028, Russia

Location

Novartis Investigative Site

Vigo, Pontevedra, 36200, Spain

Location

Novartis Investigative Site

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Location

Novartis Investigative Site

Barcelona, 08041, Spain

Location

Novartis Investigative Site

Kaohsiung City, 81346, Taiwan

Location

Novartis Investigative Site

Taichung, 40447, Taiwan

Location

Novartis Investigative Site

Taichung, 407219, Taiwan

Location

Novartis Investigative Site

Taipei, 11490, Taiwan

Location

Novartis Investigative Site

Birmingham, B15 2TH, United Kingdom

Location

Novartis Investigative Site

Liverpool, L9 7AL, United Kingdom

Location

Novartis Investigative Site

Southend, SSO 0RY, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34861168 DERIVED

MeSH Terms

Interventions

ianalumab

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

+1 (862) 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was a randomized, double-blind, placebo-controlled, multicenter, parallel-group trial which planned to enroll approximately 180 patients with moderate to severe primary Sjögren's syndrome. The study was divided into 4 study periods: Period 1: 4-week Screening to assess patient eligibility. Period 2: 24-week Blinded treatment period. Period 3: An extended blinded treatment period of 28 weeks. After Week 24 assessments, patients in the ianalumab 300 mg arm were re-randomized in a 1:1 ratio to either continue on ianalumab 300 mg s.c. q4w or switch to matching placebo up to Week 52. Period 4: Post-treatment safety follow-up period. Patients who prematurely discontinued the study treatment at any time point or completed the treatment as planned entered the safety follow-up period.

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 15, 2016
• Study Start: June 27, 2017
• Primary Completion: June 30, 2020
• Study Completion: September 23, 2021
• Last Updated: January 7, 2025
• Results First Posted: October 29, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

IT (3); DE (4); FR (2); NL (1); ES (3); RO (2); CL (2); TW (4); AU (1); US (9); BE (2); IL (1); JP (4); AR (4); PL (1); PT (4); HU (2); RU (4); GB (3)