A Phase 3 interventional study of VAY736 and Placebo in Sjögren´s Disease, sponsored by Novartis Pharmaceuticals. Recruiting at 72 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
China, India, France, Taiwan, Austria, Brazil, Colombia, Czechia, Germany, Hungary, Netherlands, Portugal, Slovakia, Spain, Switzerland, United Kingdom
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.
2,229 studies on the registry are indexed under Fatigue; 426 are open to participants now.
This study's planned enrollment of 570 is above the median of 54 across 1,757 interventional studies indexed under Fatigue.
Browse Fatigue studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
VAY736 once monthly solution for injection for subcutaneous use.
Drug: VAY736
Placebo once monthly solution for injection for subcutaneous use.
Drug: Placebo
VAY736 once monthly solution for injection for subcutaneous use.
Also known as: ianalumab
Placebo once monthly solution for injection for subcutaneous use.
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).
Time frame: Baseline to Week 52
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 52
Proportion of participants achieving ESSPRI response
Proportion of participants achieving a clinically meaningful improvement in the ESSPRI score at Week 52.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 52
Plan to share: 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
No publications or documents are linked to this record.
China, India, France, Taiwan, Austria, Brazil, Colombia, Czechia, Germany, Hungary, Netherlands, Portugal, Slovakia, Spain, Switzerland, United Kingdom
Austria, Brazil, Colombia, Czechia, Germany, Hungary, Netherlands, Portugal, Slovakia, Spain, Switzerland, United Kingdom
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Ianalumab