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NCT02962895 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)
A Phase 2 study of Primary Sjogren Syndrome, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 190
- Enrollment target
- 20
- Study locations
NCT02962895: Completed Phase 2 study of Primary Sjogren Syndrome, sponsored by Novartis Pharmaceuticals.
NCT02962895 is a Phase 2 study of Primary Sjogren Syndrome that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 190 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02962895, a Phase 2 study of Primary Sjogren Syndrome, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 190 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to determine the dose-response relationship of VAY736 for key efficacy and safety parameters
Primary Outcome
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score ranging 0-123. Higher scores on the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) scale are associated with poorer health states. A negative chang
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL VAY736
Study Locations (20)
Other
- Novartis Investigative Site - CABA
- Novartis Investigative Site - Córdoba
- Novartis Investigative Site - Córdoba
- Novartis Investigative Site - Graz
- Novartis Investigative Site - Brussels
- Novartis Investigative Site - Leuven
- Novartis Investigative Site - Santiago
- Novartis Investigative Site - Santiago
- Novartis Investigative Site - Brest
- Novartis Investigative Site - Lille
Pennsylvania
- UPMC - Pittsburgh
- Advanced Rheumatology and Arthritis Wellness Center - Wexford
Texas
- Baylor College Of Medicine - Houston
- First Outpatient Research Unit - San Antonio
Florida
- Integral Rheumatology and Immunology Specialists IRIS - Plantation
Indiana
- Indiana Univ School of Dentistry - Indianapolis
Maryland
- The John Hopkins Jerome L Greene Sjogren - Baltimore
Massachusetts
- Tufts School of Dental Medicine - Boston
New York
- AAIR Research Center - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2017-06-27 |
| Est. Completion | 2021-09-23 |
| Phase | Phase 2 |
What the finished NCT02962895 record still lists
NCT02962895 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% higher).
The record links to 1 condition, with Primary Sjogren Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02962895 names 20 study sites across 9 states, led by Other, Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT02962895 about?
NCT02962895 is a clinical study titled "Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)". The purpose of this study was to determine the dose-response relationship of VAY736 for key efficacy and safety parameters
What is the current status of trial NCT02962895?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 190 participants. The study started on 2017-06-27. Estimated completion is 2021-09-23.
What conditions does trial NCT02962895 study?
This clinical trial studies the following conditions: Primary Sjogren Syndrome.
What interventions are being tested in trial NCT02962895?
The interventions under investigation include: Placebo (OTHER), VAY736 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02962895?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02962895 being conducted?
This trial has 20 study locations across Florida, Indiana, Maryland, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02962895's enrollment target sits among peer trials
190 353rd of 2000 higher than 1,646 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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