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NCT02843659 · ClinicalTrials.gov registry record · Phase 2
Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Terminated
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT02843659: Clinical Trial Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT02843659 is a Phase 2 study that was terminated before completion, run by Bristol-Myers Squibb. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02843659, a Phase 2 study, was terminated before completion, sponsored by Bristol-Myers Squibb.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the efficacy of treatment with either lulizumab or BMS-986142 versus placebo in subjects with moderate to severe primary Sjögren's syndrome as measured by the change from baseline in ESSDAI at Week 12 between active treatment arms (lulizumab or BMS-986142, respectively) and the placebo arm.
Primary Outcome
The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, w
Interventions
- DRUG Placebo
- DRUG BMS-986142
- DRUG BMS-931699
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2016-10-18 |
| Est. Completion | 2017-07-24 |
| Phase | Phase 2 |
Why NCT02843659 stopped before completion
NCT02843659 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02843659 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02843659 about?
NCT02843659 is a clinical study titled "Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome". The primary objective of this study is to evaluate the efficacy of treatment with either lulizumab or BMS-986142 versus placebo in subjects with moderate to severe primary Sjögren's syndrome as measured by the change from baseline in ESSDAI at Week 12 between active treatment arms (lulizumab or BMS-...
What is the current status of trial NCT02843659?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2016-10-18. Estimated completion is 2017-07-24.
What interventions are being tested in trial NCT02843659?
The interventions under investigation include: Placebo (DRUG), BMS-986142 (DRUG), BMS-931699 (DRUG).
Who is sponsoring clinical trial NCT02843659?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02843659's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 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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