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NCT05349214 · ClinicalTrials.gov registry record · Phase 3
Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome
A Phase 3 study of Sjogren Syndrome, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 506
- Enrollment target
- 20
- Study locations
NCT05349214: Active Phase 3 study of Sjogren Syndrome, sponsored by Novartis Pharmaceuticals.
NCT05349214 is a Phase 3 study of Sjogren Syndrome that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 506 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05349214, a Phase 3 study of Sjogren Syndrome, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 506 participants
- Enrollment target
- 20
- Study locations
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)
Primary Outcome
* Plan A - United States of America and US reference countries * Plan B - EU, China, other non-US Regions and EU reference countries Dose response measured by change multi-dimensional disease activity as assessed by the physician. Score range is 0-123. Higher scores on the EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) scale are associated with poorer health states A negative change from baseline indicates improvement in disease status.
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
| Field | Value |
|---|---|
| Enrollment Target | 506 participants |
| Start Date | 2022-08-04 |
| Est. Completion | 2027-05-13 |
| Phase | Phase 3 |
What the registry record for NCT05349214 still lists
NCT05349214 is an interventional study that assigns participants to a tested intervention. The registered 506 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower).
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.
NCT05349214 names 20 study sites across 12 states, led by Florida, Illinois, California.
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.
What interventions are being tested in trial NCT05349214?
The interventions under investigation include: Placebo (OTHER), VAY736 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05349214?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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.
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506 741st of 2000 higher than 1,259 of 2,000 other Phase 3 trials
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