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

ClinicalTrials.gov ID: NCT07621809

Public ClinicalTrials.gov record NCT07621809. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 22, 2026, 8:12 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07621809
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Novartis Pharmaceuticals; Industry
Enrollment: 570 participants

Conditions and interventions

Conditions

Sjögren´s Disease

Interventions

VAY736 Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 16, 2026 (Actual)
Primary completion: Aug 15, 2029 (Estimated)
Completion: Aug 14, 2033 (Estimated)
Last update posted: Oct 13, 2026

2026 – 2033

United States locations

U.S. sites: 20
U.S. states: 12
U.S. cities: 20

Facility	City	State	ZIP	Site status
Sun Valley Arthritis Center Ltd	Peoria	Arizona	85381	Recruiting
Clinical Res Of W Florida	Clearwater	Florida	33765	Recruiting
Clinical Research of West Florida Inc	Tampa	Florida	33606	Recruiting
Willow Rheumatology Wellness	Willowbrook	Illinois	60527	Recruiting
Tufts Medical Center	Boston	Massachusetts	02111	Recruiting
Clinical Research Inst of MI	Saint Clair Shores	Michigan	48081	Recruiting
Arthritis Rheumatology and Bone Disease Associates PA	Voorhees Township	New Jersey	08043	Recruiting
St Lawrence Health System	Potsdam	New York	13676	Recruiting
On Site Clinical Solutions Llc	Charlotte	North Carolina	28202	Recruiting
Carolina Arthritis Associates	Wilmington	North Carolina	28401	Recruiting
RAO Research LLC	Oklahoma City	Oklahoma	73116	Recruiting
West Tennessee Research Institute	Jackson	Tennessee	38305	Recruiting
Shelby Research LLC	Memphis	Tennessee	38119	Recruiting
Novel Research LLC	Bellaire	Texas	77401	Recruiting
Arthritis Care of Texas	Corpus Christi	Texas	78415	Recruiting
Precision Comprehensive Clinical Research Solutions	Euless	Texas	76040	Recruiting
Abigail Neiman MD PA	Houston	Texas	77024	Recruiting
Accurate Clinical Research	League City	Texas	77573	Recruiting
TEKTON	Leander	Texas	78641	Recruiting
Arthritis Northwest PLLC	Spokane	Washington	99216	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07621809, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 13, 2026 · Synced Oct 22, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07621809 live on ClinicalTrials.gov.

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