Last Update: Sep 09, 2026 A Randomized, Double-blind, Placebo-controlled, 2-arm Multicenter Phase III Study to Assess the Efficacy and Safety of Ianalumab in Participants With Sjogren's Disease With High Symptom Burden (THALASSA) ClinicalTrials.gov Identifier: [NCT07621809](https://clinicaltrials.gov/ct2/show/NCT07621809) Novartis Reference Number:CVAY736A22301 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description 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. This is a double-blind, randomized, placebo-controlled multicenter 2-arm Phase III study, evaluating 300 mg ianalumab s.c. against placebo s.c. in adult participants with Sjögren's disease with high symptom burden. Condition Sjögren´s Disease Phase Phase3 Overall Status Recruiting Number of Participants570 Start Date Jul 16, 2026 Completion Date Aug 13, 2033 Gender All Age(s) 18 Years - (Adult, Older Adult) ## Interventions Drug ### Placebo Placebo once monthly solution for injection for subcutaneous use. Drug ### VAY736 VAY736 once monthly solution for injection for subcutaneous use. ## Eligibility Criteria 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). Australia #### Novartis Investigative Site Recruiting Maroochydore,Queensland,4558,Australia Canada #### Novartis Investigative Site Recruiting Rimouski,Quebec,G5l 5t1,Canada South Korea #### Novartis Investigative Site Recruiting Gwangju,61469,South Korea United States #### Precision Comprehensive Clinical Research Solutions Recruiting Euless,Texas,76040,United States ###### Akshay Shetty Email: ###### Renuka Basavaraju #### Arthritis Care of Texas Recruiting Corpus Christi,Texas,78415,United States ###### Tatum Trevino Phone: [+1 361 400 7700]() Email: ###### Eric Ping Chiang #### Abigail Neiman MD PA Recruiting Houston,Texas,77024,United States ###### Abigail Neiman ###### Hina Arshad Phone: [+1 832 834 5627]() Email: #### TEKTON Recruiting Leander,Texas,78641,United States ###### Paul K Pickrell ###### Stephanie Garcia Phone: [+1 512 388 5717]() Email: #### Willow Rheumatology Wellness Recruiting Willowbrook,Illinois,60527,United States ###### Angela R Crowley ###### Avni Singh Phone: [+1 630 794 8649]() Email: #### West Tennessee Research Institute Recruiting Jackson,Tennessee,38305,United States ###### Jacob A Aelion ###### Judith Padilla Phone: [+1 731 664 0002]() Email: #### Shelby Research LLC Recruiting Memphis,Tennessee,38119,United States ###### Ramesh C Gupta ###### Subhash Eedarapalli Phone: [+1 901 681 9670]() Email: #### Arthritis Northwest PLLC Recruiting Spokane,Washington,99216,United States ###### Corine Nguyen Phone: [+1 509 838 6500]() Email: ###### Michael C Coan #### Clinical Research of West Florida Inc Recruiting Tampa,Florida,33606,United States ###### Sydney K Mullen Phone: [+1 813 870 1292]() Email: ###### John Carter #### On Site Clinical Solutions Llc Recruiting Charlotte,North Carolina,28202,United States ###### Roshini Narayanaswamy Email: ###### Rakesh C Patel #### Accurate Clinical Research Recruiting League City,Texas,77573,United States ###### David Batista Phone: [+1 281 422 7179]() Email: ###### Sabeen Najam #### Sun Valley Arthritis Center Ltd Recruiting Peoria,Arizona,85381,United States ###### Jessica Peters Phone: [+1 623 825 5591]() Email: ###### Joy Schechtman #### Clinical Res Of W Florida Recruiting Clearwater,Florida,33765,United States ###### Bridget Ben-Hayon Phone: [+1 727 466 0078]() Email: ###### Rodney Daniel #### Clinical Research Inst of MI Recruiting Saint Clair Shores,Michigan,48081,United States ###### Amelia Laurence Phone: [+1 586 777 7577]() Email: ###### Andrew Sulich #### RAO Research LLC Recruiting Oklahoma City,Oklahoma,73116,United States ###### John Goetzinger ###### Mary Turner Phone: [+1 405 608 8060]() Email: #### Novel Research LLC Recruiting Bellaire,Texas,77401,United States ###### Hassan Khan Phone: [+1 281 944 3610]() Email: ###### Wajeeha Yousaf ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: [](mailto:) #### Novartis Pharmaceuticals Phone: [ 1-888-669-6682](tel:1-888-669-6682) Email: