Recruiting

Phase 3

IanalumabTwo Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07621809

Conditions

Sjögren´s Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VAY736

Placebo

Study Details

Brief summary:

The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.

Conditions

Sjögren´s Disease

Study ID

NCT07621809

Start date

Jul 16, 2026

Status verified date

Sep, 2026

Completion date

Aug 13, 2033

Anticipated

Primary completion date

Aug 14, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Male or female participants ≥ 18 years of age or as per country-specific legal adult age, whichever is higher
Classification of Sjögren's disease according to ACR/EULAR 2016 criteria.
Seropositive for anti-Ro/SSA antibodies at screening
SSSD oral dryness score ≥ 5 and overall SSSD summary score ≥5 collected over 14 consecutive days during the Screening 2 period
Screening ESSDAI biologic and/or hematologic domain > 0 Note: laboratory abnormalities for scoring must be confirmed as associated with Sjögren's disease and not be due to other underlying conditions.
Stimulated whole salivary flow (sSF) rate > 0.3 mL/min at screening
Participants taking hydroxychloroquine (≤ 400 mg/day) are allowed to continue their medication, and must have been on a stable dose for at least 4 weeks prior to screening, which should be maintained throughout the 52 weeks of the blinded treatment period.
Predniso(lo)ne ≤ 5 mg/day or equivalent are allowed for up to 16 weeks post-randomization.

Exclusion Criteria:

Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness, specifically:
Systemic sclerosis (SSc)
Any other associated connective tissue disease (e.g., lupus nephritis (LN), large vessel vasculitis (LVV), Sharp syndrome (mixed connective tissue disease)) that is active and requires immunosuppressive treatment outside the scope of this trial and would impede on Sjögren's disease organ domain assessments.
Concurrent diagnosis or history of fibromyalgia or overlapping inflammatory diseases
Prior treatment with B-cell-depleting therapy (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) within:
36 weeks prior to randomization, or
As long as B-cell count is less than the lower limit of normal (LLN) or baseline value prior to receipt of previous B-cell-depleting therapy (whichever is lower) at Screening.
Prior treatment with ianalumab
Prior treatment with any of the following within the given period prior to Screening:
Within 5 half-lives prior to Screening: iscalimab (anti-CD 40 mAb), belimumab (anti-BAFF mAb), abatacept (CTLA4-Fc Ig), anti-tumor necrosis factor alpha (TNFα) biologic agents, immunoglobulins (i.v./s.c.), plasmapheresis, any other investigational biologic medicines under investigation for Sjögren's disease
Within 4 weeks OR drug-specific 5 half-lives elimination period (if longer than 4 weeks) prior to screening: i.v. or oral cyclophosphamide, mycophenolate mofetil (MMF), methotrexate, azathioprine, i.v. or oral cyclosporine A or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors).
History of hypersensitivity to any of the study drugs or their excipients, or to drugs of similar chemical classes (e.g., mAb of IgG1 class) or to any of the constituents of the study drug formulation (sucrose, L-histidine hydrochloride/L-histidine, polysorbate 20).

Study Design

Enrollment

570 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VAY736 - 300 mg

VAY736 once monthly solution for injection for subcutaneous use.

placebo comparator: Placebo

Placebo once monthly solution for injection for subcutaneous use.

Interventions

VAY736

VAY736 once monthly solution for injection for subcutaneous use.

Placebo

Placebo once monthly solution for injection for subcutaneous use.

Primary outcome measure

Change from baseline in SSSD oral dryness score [ Time Frame: Baseline to Week 52 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Sun Valley Arthritis Center Ltd

Recruiting

Peoria, Arizona, United States, 85381

Contacts

Jessica Peters

+1 623 825 5591 jessica.peters@sclamanagement.com

Principal Investigator:

Joy Schechtman

Clinical Res Of W Florida

Recruiting

Clearwater, Florida, United States, 33765

Contacts

Bridget Ben-Hayon

+1 727 466 0078 bben@crwf.com

Principal Investigator:

Rodney Daniel

Clinical Research of West Florida Inc

Recruiting

Tampa, Florida, United States, 33606

Contacts

Sydney K Mullen

+1 813 870 1292 smullen@crwf.com

Principal Investigator:

John Carter

Willow Rheumatology Wellness

Recruiting

Willowbrook, Illinois, United States, 60527

Contacts

Avni Singh

+1 630 794 8649 asingh@willowrheum.com

Principal Investigator:

Angela R Crowley

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Elizabeth Tzavaras

+1 504 427 7001 Elizabeth.Tzavaras@tufts.edu

Principal Investigator:

Athena Papas

Clinical Research Inst of MI

Recruiting

Saint Clair Shores, Michigan, United States, 48081

Contacts

Amelia Laurence

+1 586 777 7577 alaurence@researchmi.com

Principal Investigator:

Andrew Sulich

St Lawrence Health System

Recruiting

Potsdam, New York, United States, 13676

Contacts

Brittany Geiler

+1 315 261 5611 brittany.geiler@rochesterregional.org

Principal Investigator:

Eyal Kedar

On Site Clinical Solutions Llc

Recruiting

Charlotte, North Carolina, United States, 28202

Contacts

Roshini Narayanaswamy

rnara@onsiteclinical.com

Principal Investigator:

Rakesh C Patel

RAO Research LLC

Recruiting

Oklahoma City, Oklahoma, United States, 73116

Contacts

Mary Turner

+1 405 608 8060 mturner@raoklahoma.com

Principal Investigator:

John Goetzinger

West Tennessee Research Institute

Recruiting

Jackson, Tennessee, United States, 38305

Contacts

Judith Padilla

+1 731 664 0002 jpadilla@arthritisclinic.org

Principal Investigator:

Jacob A Aelion

Shelby Research LLC

Recruiting

Memphis, Tennessee, United States, 38119

Contacts

Subhash Eedarapalli

+1 901 681 9670 shelbyres261@outlook.com

Principal Investigator:

Ramesh C Gupta

Novel Research LLC

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Hassan Khan

+1 281 944 3610 khan@novelresearch.net

Principal Investigator:

Wajeeha Yousaf

Arthritis Care of Texas

Recruiting

Corpus Christi, Texas, United States, 78415

Contacts

Tatum Trevino

+1 361 400 7700 tatum.trevino@sclamanagement.com

Principal Investigator:

Eric Ping Chiang

Precision Comprehensive Clinical Research Solutions

Recruiting

Euless, Texas, United States, 76040

Contacts

Akshay Shetty

ashetty@pccrsolutions.com

Principal Investigator:

Renuka Basavaraju

Abigail Neiman MD PA

Recruiting

Houston, Texas, United States, 77024

Contacts

Hina Arshad

+1 832 834 5627 hina@novelresearch.net

Principal Investigator:

Abigail Neiman

Accurate Clinical Research

Recruiting

League City, Texas, United States, 77573

Contacts

David Batista

+1 281 422 7179 dbatista@accurateclinicalresearch.com

Principal Investigator:

Sabeen Najam

TEKTON

Recruiting

Leander, Texas, United States, 78641

Contacts

Stephanie Garcia

+1 512 388 5717 sgarcia@tektonresearch.com

Principal Investigator:

Paul K Pickrell

Arthritis Northwest PLLC

Recruiting

Spokane, Washington, United States, 99216

Contacts

Corine Nguyen

+1 509 838 6500 cnguyen@arthritisnw.com

Principal Investigator:

Michael C Coan

Novartis Investigative Site

Recruiting

Rimouski, Quebec, Canada, G5L 5T1

Novartis Investigative Site

Recruiting

Sherbrooke, Quebec, Canada, J1E 0N8

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Sep 28, 2026

Last verified

Sep, 2026

Keywords

Sjögren´s disease
ianalumab
VAY736
high symptom burden
B cell depleting therapy
BAFF receptor
BAFF-R
ESSDAI
ESSPRI
SSSD
monoclonal antibody
dryness
fatigue
autoimmune disease
sicca syndrome
THALASSA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.