Sjögren´s DiseasePhase 3THALASSANCT07621809
Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden
A Phase 3 study testing VAY736 in people with Sjögren´s Disease, run by Novartis Pharmaceuticals at 33 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjögren´s Disease
- What is being tested?
- VAY736
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 570 participants
- Where
- 33 sitesin 8 countries
- Study dates
- 16 Jul 2026to 14 Aug 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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).
Trial locations and contacts
33 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
33 sites in 8 countries
United States20 sites, 20 recruiting
- Recruiting
Novel Research LLC
Bellaire, Texas, 77401
Hassan Khan, +1 281 944 3610, khan@novelresearch.net
Wajeeha Yousaf
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Elizabeth Tzavaras, +1 504 427 7001, Elizabeth.Tzavaras@tufts.edu
Athena Papas
- Recruiting
On Site Clinical Solutions Llc
Charlotte, North Carolina, 28202
Roshini Narayanaswamy, rnara@onsiteclinical.com
Rakesh C Patel
- Recruiting
Clinical Res Of W Florida
Clearwater, Florida, 33765
Bridget Ben-Hayon, +1 727 466 0078, bben@crwf.com
Rodney Daniel
- Recruiting
Arthritis Care of Texas
Corpus Christi, Texas, 78415
Tatum Trevino, +1 361 400 7700, tatum.trevino@sclamanagement.com
Eric Ping Chiang
- Recruiting
Precision Comprehensive Clinical Research Solutions
Euless, Texas, 76040
Akshay Shetty, ashetty@pccrsolutions.com
Renuka Basavaraju
- Recruiting
Abigail Neiman MD PA
Houston, Texas, 77024
Hina Arshad, +1 832 834 5627, hina@novelresearch.net
Abigail Neiman
- Recruiting
West Tennessee Research Institute
Jackson, Tennessee, 38305
Judith Padilla, +1 731 664 0002, jpadilla@arthritisclinic.org
Jacob A Aelion
- Recruiting
Accurate Clinical Research
League City, Texas, 77573
David Batista, +1 281 422 7179, dbatista@accurateclinicalresearch.com
Sabeen Najam
- Recruiting
TEKTON
Leander, Texas, 78641
Michael Helms, +1 512 388 5717, michael.helms@tektonresearch.com
Paul K Pickrell
- Recruiting
Shelby Research LLC
Memphis, Tennessee, 38119
Subhash Eedarapalli, +1 901 681 9670, shelbyres261@outlook.com
Ramesh C Gupta
- Recruiting
RAO Research LLC
Oklahoma City, Oklahoma, 73116
Mary Turner, +1 405 608 8060, mturner@raoklahoma.com
John Goetzinger
- Recruiting
Sun Valley Arthritis Center Ltd
Peoria, Arizona, 85381
Jessica Peters, +1 623 825 5591, jessica.peters@sclamanagement.com
Joy Schechtman
- Recruiting
St Lawrence Health System
Potsdam, New York, 13676
Mckailey Lyndaker, +1 315 261 5611, mckailey.lyndaker@rochesterregional.org
Eyal Kedar
- Recruiting
Clinical Research Inst of MI
Saint Clair Shores, Michigan, 48081
Amelia Laurence, +1 586 777 7577, alaurence@researchmi.com
Andrew Sulich
- Recruiting
Arthritis Northwest PLLC
Spokane, Washington, 99216
Corine Nguyen, +1 509 838 6500, cnguyen@arthritisnw.com
Michael C Coan
- Recruiting
Clinical Research of West Florida Inc
Tampa, Florida, 33606
Sydney K Mullen, +1 813 870 1292, smullen@crwf.com
John Carter
- Recruiting
Arthritis Rheumatology and Bone Disease Associates PA
Voorhees Township, New Jersey, 08043
Shannon Chalginow, +1856 424 5005, schalginow@arbda.com
Nadishani Dissanayaka
- Recruiting
Willow Rheumatology Wellness
Willowbrook, Illinois, 60527
Avni Singh, +1 630 794 8649, asingh@willowrheum.com
Angela R Crowley
- Recruiting
Carolina Arthritis Associates
Wilmington, North Carolina, 28401
Jodi Daniel, +1 910 762 1182, study@carolinaarthritis.com
Mark Harris
Canada3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Rimouski, Quebec, G5L 5T1
- Recruiting
Novartis Investigative Site
Sherbrooke, Quebec, J1E 0N8
- Recruiting
Novartis Investigative Site
Sydney, Nova Scotia, B1P 1P3
India3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Belagavi, 590001
- Recruiting
Novartis Investigative Site
Jaipur, Rajasthan, 302004
- Recruiting
Novartis Investigative Site
Nashik, Maharashtra, 422101
South Korea3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, 13620
- Recruiting
Novartis Investigative Site
Gwangju, 61469
- Recruiting
Novartis Investigative Site
Seoul, 06591
Australia1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Maroochydore, Queensland, 4558
France1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Le Kremlin-Bicêtre, 94275
About this study
Official title: 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)
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.
Read the detailed description
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.
- Conditions
- Sjögren´s Disease
- Being tested
- VAY736, Placebo
- 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
- Medical subject headings
- Fatigue, Autoimmune Diseases, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAY736Drug
Also called ianalumab
VAY736 once monthly solution for injection for subcutaneous use.
PlaceboDrug
Placebo once monthly solution for injection for subcutaneous use.
| Study group | Role | What they receive |
|---|---|---|
| VAY736 - 300 mg | Experimental | VAY736 once monthly solution for injection for subcutaneous use. Receives: Drug: VAY736 |
| Placebo | Placebo comparator | Placebo once monthly solution for injection for subcutaneous use. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in SSSD oral dryness score
The Sjögren's Syndrome Symptom Diary (SSSD) oral dryness score is a patient-reported measure assessing severity of mouth dryness. The mouth dryness symptom is scored daily on a numerical scale (higher scores = worse symptoms).
Measured: Baseline to Week 52
Secondary outcomes (9)
Change from baseline in SSSD summary score
The SSSD summary score is calculated over a defined time window. Each symptom is scored daily on a numerical scale (higher scores = worse symptoms).
Measured: Baseline to Week 52
Change from baseline in ESSPRI score
The EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score is a validated patient-reported outcome assessing three symptom domains: dryness, pain and fatigue. Scores range from 0 (no symptoms) to 10 (worst imaginable symptoms).
Measured: Baseline to Week 52
Change from baseline in stimulated whole salivary flow (sSF)
The stimulated whole salivary flow rate, is an objective functional assessment of salivary gland activity, measuring saliva production under stimulation. Higher values indicate better salivary gland function.
Measured: Baseline to Week 52
Change from baseline in Patient's Global Assessment (PaGA) NRS score
The Patient's Global Assessment of disease activity captures the patient's overall perception of disease activity. It is assessed using a Numerical Rating Scale (NRS) from 0 to 10. Higher scores indicate worse perceived disease activity.
Measured: Baseline to Week 52
Proportion of participants achieving SSSD response
Proportion of participants achieving a clinically meaningful improvement in the SSSD summary score at Week 52.
Measured: Week 52
Proportion of participants achieving ESSPRI response
Proportion of participants achieving a clinically meaningful improvement in the ESSPRI score at Week 52.
Measured: Week 52
Change from baseline in SSSD eye dryness score
The SSSD eye dryness item score is a patient-reported measure assessing severity of eye dryness. The eye dryness symptom is scored daily on a numerical scale (higher scores = worse symptoms).
Measured: Baseline to Week 52
Change from baseline in FACIT-Fatigue score
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score is a 13-item questionnaire assessing fatigue and its impact on daily activities over the previous 7 days. Higher scores indicate less fatigue / better functioning.
Measured: Baseline to Week 52
Change from baseline in Sjögren's-Related Quality of Life (SRQoL) score
The Sjögren's-Related Quality of Life (SRQoL) score is a disease-specific quality-of-life instrument evaluating the impact of Sjögren's disease on physical, emotional, social and daily functioning. Lower scores indicate better quality of life.
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start16 Jul 2026
- Primary completion15 Aug 2029 (estimated)
- Study completion14 Aug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjögren´s DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621809
- Sponsor's protocol ID
- CVAY736A22301
- Other IDs
- 2025-522271-29-00, 2025
- Acronym
- THALASSA
- Status last verified
- Oct 2026
- First submitted
- 26 May 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 ID
- NCT07621809
- Acronym / sponsor ID
- THALASSA / CVAY736A22301
- Conditions
- Sjögren´s Disease
- Keywords
- Sjögren´s disease, ianalumab, VAY736, high symptom burden, B cell depleting therapy, BAFF receptor, BAFF-R, ESSDAI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- 15 Aug 2029 (estimated)
- Study completion
- 14 Aug 2033 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAY736 - 300 mg | Experimental | Drug: VAY736VAY736 once monthly solution for injection for subcutaneous use. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once monthly solution for injection for subcutaneous use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAY736Also: ianalumabVAY736 once monthly solution for injection for subcutaneous use. | Drug | VAY736 - 300 mg |
| PlaceboPlacebo once monthly solution for injection for subcutaneous use. | Drug | Placebo |
Primary outcome
Change from baseline in SSSD oral dryness score
Time frame: Baseline to Week 52
The Sjögren's Syndrome Symptom Diary (SSSD) oral dryness score is a patient-reported measure assessing severity of mouth dryness. The mouth dryness symptom is scored daily on a numerical scale (higher scores = worse symptoms).
9 secondary outcomes
Change from baseline in SSSD summary score
Time frame: Baseline to Week 52
Change from baseline in ESSPRI score
Time frame: Baseline to Week 52
Change from baseline in stimulated whole salivary flow (sSF)
Time frame: Baseline to Week 52
Change from baseline in Patient's Global Assessment (PaGA) NRS score
Time frame: Baseline to Week 52
Proportion of participants achieving SSSD response
Time frame: Week 52
Proportion of participants achieving ESSPRI response
Time frame: Week 52
Change from baseline in SSSD eye dryness score
Time frame: Baseline to Week 52
Change from baseline in FACIT-Fatigue score
Time frame: Baseline to Week 52
Change from baseline in Sjögren's-Related Quality of Life (SRQoL) score
Time frame: Baseline to Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
33 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VAY736 in people with Sjögren´s Disease, run by Novartis Pharmaceuticals at 33 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Canada, India, South Korea, Australia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in SSSD oral dryness score (time frame: Baseline to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.