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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified June 2026 by Novartis Pharmaceuticals
Sponsor
Novartis Pharmaceuticals
Information Provided by (Responsible Party)
Novartis Pharmaceuticals
Clinicaltrials.gov Identifier
NCT07621809
Other Study ID Numbers:
CVAY736A22301
First Submitted
May 25, 2026
First Posted
June 1, 2026
Last Update Posted
July 8, 2026
Last Verified
June 2026

ClinicalTrials.gov processed this data on July 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
Sjögren´s Disease
Drug: VAY736Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment570 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA 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)
Study Start DateJuly 14, 2026
Actual Primary Completion Date3yrs 3w from now
Actual Study Completion Date7yrs 2w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
VAY736 - 300 mg
VAY736 once monthly solution for injection for subcutaneous use.
Drug: VAY736
VAY736 once monthly solution for injection for subcutaneous use.
Placebo
Placebo once monthly solution for injection for subcutaneous use.
Drug: Placebo
Placebo once monthly solution for injection for subcutaneous use.

Outcome Measures

Primary Outcome Measures
  1. 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).
Secondary Outcome Measures
  1. 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).
  2. 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).
  3. 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.
  4. 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.
  5. Proportion of participants achieving SSSD response
    Proportion of participants achieving a clinically meaningful improvement in the SSSD summary score at Week 52.
  6. Proportion of participants achieving ESSPRI response
    Proportion of participants achieving a clinically meaningful improvement in the ESSPRI score at Week 52.
  7. 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).
  8. 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.
  9. 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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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).

Contacts and Locations

Sponsors and CollaboratorsNovartis Pharmaceuticals
Locations
On Site Clinical Solutions Llc | Charlotte North Carolina, United States, 28202Accurate Clinical Research | League City Texas, United States, 77573