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ACTIVE NOT RECRUITING Phase 3

Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome

NCT05349214 · View on ClinicalTrials.gov ↗

Study Summary

A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-2)

Conditions Studied

Interventions

  • OTHER Placebo
  • BIOLOGICAL VAY736

Study Locations (20)

Florida

  • Bay Area Arthritis And Osteoporosis — Brandon
  • GNP Research — Cooper City
  • Sarasota Arthritis Res Ctr — Sarasota

Illinois

  • Clin Invest Specialists Inc — Orland Park
  • Clinic of Robert Hozman — Skokie
  • Clinical Investigation Specialists, Inc. — Wauconda

California

  • Providence Medical Foundation — Fullerton
  • Advanced Medical Research — La Palma

Georgia

  • Augusta University Georgia — Augusta
  • North Georgia Rheumatology Group — Lawrenceville

North Carolina

  • On Site Clinical Solutions Llc — Charlotte
  • Arthritis and Osteoporosis — Charlotte

Tennessee

  • West Tennessee Research Institute — Jackson
  • Ramesh C Gupta MD Memphis TN — Memphis

Kansas

  • University of Kansas Hospital — Kansas City

Massachusetts

  • Tufts School of Dental Medicine — Boston

Trial Details

FieldValue
Enrollment Target 506 participants
Start Date 2022-08-04
Est. Completion 2027-05-13
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05349214

The ClinicalTrials.gov registry entry for NCT05349214 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 506 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: NCT05349214 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, Illinois, 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 NCT05349214 about?

NCT05349214 is a clinical study titled "Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome". A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-2)

What is the current status of trial NCT05349214?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 506 participants. The study started on 2022-08-04. Estimated completion is 2027-05-13.

What conditions does trial NCT05349214 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 NCT05349214?

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 NCT05349214?

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 NCT05349214 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial