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NCT05985915 · ClinicalTrials.gov registry record · Phase 3
A Randomized, Double-blind 2-arm, Followed by an Open-label 1-arm, NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.
A Phase 3 study of Sjogren's Syndrome, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 612
- Enrollment target
- 20
- Study locations
NCT05985915: Active Phase 3 study of Sjogren's Syndrome, sponsored by Novartis Pharmaceuticals.
NCT05985915 is a Phase 3 study of Sjogren's Syndrome that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 612 participants, above the 258-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (137% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05985915, a Phase 3 study of Sjogren's Syndrome, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 612 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjögren's syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301 \[NCT05350072\] or CVAY736A2302 \[NCT05349214\]).
Primary Outcome
Assessment of safety and tolerability of ianalumab (VAY736) in patients with active Sjogrens syndrome
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Ianalumab (VAY736)
Study Locations (20)
Florida
- Bay Area Arthritis And Osteoporosis - Brandon
- GNP Research - Cooper City
- Sarasota Arthritis Res Ctr - Sarasota
- West Broward Rheumatology Associates Inc - Tamarac
California
- Providence Medical Foundation - Fullerton
- Advanced Medical Research - La Palma
- Medvin Clinical Research - Van Nuys
North Carolina
- On Site Clinical Solutions Llc - Charlotte
- Arthritis and Osteoporosis - Charlotte
- Carolina Arthritis Associates - Wilmington
Georgia
- Augusta University Georgia - Augusta
- North GA Rheumatology Group PC - Suwanee
New York
- Winthrop University Hospital - Mineola
- St Lawrence Health System - Potsdam
Illinois
- Clin Invest Specialists Inc - Orland Park
Kansas
- University of Kansas Hospital - Kansas City
Louisiana
- Ochsner Health System - Baton Rouge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 612 participants |
| Start Date | 2023-10-27 |
| Est. Completion | 2033-04-22 |
| Phase | Phase 3 |
What the registry record for NCT05985915 still lists
NCT05985915 is an interventional study that assigns participants to a tested intervention. The registered 612 participants enrollment target is mid-sized for trials with a published cap, above the 258-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (137% higher).
The record links to 1 condition, with Sjogren's Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05985915 names 20 study sites across 11 states, led by Florida, California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05985915 about?
NCT05985915 is a clinical study titled "A Randomized, Double-blind 2-arm, Followed by an Open-label 1-arm, NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.". The purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjögren's syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301 \[NCT05350072\] or CVAY736A2302 \[NCT05349214\]).
What is the current status of trial NCT05985915?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 612 participants. The study started on 2023-10-27. Estimated completion is 2033-04-22.
What conditions does trial NCT05985915 study?
This clinical trial studies the following conditions: Sjogren's Syndrome.
What interventions are being tested in trial NCT05985915?
The interventions under investigation include: Placebo (OTHER), Ianalumab (VAY736) (DRUG).
Who is sponsoring clinical trial NCT05985915?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05985915 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.
Learn More About Clinical Trials
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Where NCT05985915's enrollment target sits among peer trials
612 5th of 20 higher than 16 of 20 other Sjogren's Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sjogren's Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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