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NCT05350072 · ClinicalTrials.gov registry record · Phase 3
Two-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
- 276
- Enrollment target
- 20
- Study locations
NCT05350072: Active Phase 3 study of Sjogren Syndrome, sponsored by Novartis Pharmaceuticals.
NCT05350072 is a Phase 3 study of Sjogren Syndrome that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 276 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05350072, 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
- 276 participants
- Enrollment target
- 20
- Study locations
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)
Primary Outcome
Efficacy (Plan A: US and US reference countries and 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)
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 |
What the registry record for NCT05350072 still lists
NCT05350072 is an interventional study that assigns participants to a tested intervention. The registered 276 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 (64% 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.
NCT05350072 names 20 study sites across 15 states, led by Texas, Other, California.
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.
What interventions are being tested in trial NCT05350072?
The interventions under investigation include: Placebo (OTHER), VAY736 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05350072?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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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Where NCT05350072's enrollment target sits among peer trials
276 1203rd of 2000 higher than 795 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
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