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Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome
NCT05350072 · View on ClinicalTrials.gov ↗
Study Summary
A randomized, double-blind, placebo controlled, 2-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-1)
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL VAY736
Study Locations (20)
Texas
- Precision Comprehensive Research — Colleyville
- Metroplex Clinical Research — Dallas
- Baylor College Of Medicine — Houston
- Houston Rheumatology & Arthrit — Katy
Other
- Novartis Investigative Site — Graz
- Novartis Investigative Site — Stockerau
- Novartis Investigative Site — Leuven
California
- Medvin Clinical Research — Van Nuys
Florida
- West Broward Rheumatology Associates Inc — Tamarac
Indiana
- Indiana Univ School of Dentistry — Indianapolis
Louisiana
- Ochsner Health System — Baton Rouge
Maryland
- The John Hopkins Jerome L Greene Sjogren — Baltimore
New York
- Winthrop University Hospital — Mineola
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2022-07-28 |
| Est. Completion | 2027-05-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05350072
The ClinicalTrials.gov registry entry for NCT05350072 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 276 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Sjogren Syndrome appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05350072 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Texas, Other, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05350072 about?
NCT05350072 is a clinical study titled "Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome". A randomized, double-blind, placebo controlled, 2-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-1)
What is the current status of trial NCT05350072?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 276 participants. The study started on 2022-07-28. Estimated completion is 2027-05-06.
What conditions does trial NCT05350072 study?
This clinical trial studies the following conditions: Sjogren Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05350072?
The interventions under investigation include: Placebo (OTHER), VAY736 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05350072?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05350072 being conducted?
This trial has 20 study locations across California, Florida, Indiana, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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