Phase 3: testing VAY736 for Sjögren´s Disease
This study wants to demonstrate the how well it works 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.
Official registry: https://clinicaltrials.gov/study/NCT07621809 · Novartis Pharmaceuticals · enrollment listed as 570
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are VAY736, or Placebo. The registry lists allocation as randomized. This study wants to demonstrate the how well it works 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.
They plan to enroll about 570 people at 70 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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)
Interventions: VAY736, Placebo
Primary outcome (registry wording): Change from baseline in SSSD oral dryness score
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
Who the registry excludes
- Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness, specifically:
- Systemic sclerosis (SSc)
- 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
Public study contact (from the registry)
Novartis Pharmaceuticals
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
70 listed- Sun Valley Arthritis Center Ltd — Peoria, Arizona (recruiting)
- Unity Health Rheumatology — Searcy, Arkansas (recruiting)
- Medvin Clinical Research — Van Nuys, California (recruiting)
- Clinical Res Of W Florida — Clearwater, Florida (recruiting)
- GNP Research — Cooper City, Florida (recruiting)
- Clinical Research of West Florida Inc — Tampa, Florida (recruiting)
- Willow Rheumatology Wellness — Willowbrook, Illinois (recruiting)
- Tufts Medical Center — Boston, Massachusetts (recruiting)
- Clinical Research Inst of MI — Saint Clair Shores, Michigan (recruiting)
- Arthritis Rheumatology and Bone Disease Associates PA — Voorhees Township, New Jersey (recruiting)
- St Lawrence Health System — Potsdam, New York (recruiting)
- On Site Clinical Solutions Llc — Charlotte, North Carolina (recruiting)
+ 47 sites outside the US on the same record
FAQ about this NCT record
Is NCT07621809 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07621809?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07621809?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary