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NCT02265744 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 730
- Enrollment target
NCT02265744: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT02265744 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 730 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (449% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02265744, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 730 participants
- Enrollment target
Study Summary
Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythematosus in male and female adults. Patients who qualify will be randomized to either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the initial 24 weeks of treatment and who are responding to therapy will have the option to continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and safety will be assessed over the course of the study through laboratory values, various rating scales accepted in systemic lupus erythematosus studies and patient self reporting.
Primary Outcome
The British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) is a measure of systemic lupus erythematosus (SLE) response. BICLA is defined as: British Isle Lupus Assessment Group improvement, defined as BILAG As at Baseline improved to B/C/D, and BILAG Bs at baseline improved to C/D, and no BILAG worsening in other BILAG organ systems such that there are no new BILAG As or greater than 1 new BILAG B; and no worsening in the SLEDAI-2K total score compared to Baseline
Interventions
- DRUG BMS-931699
- DRUG Placebo matching BMS-931699
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 730 participants |
| Start Date | 2014-11-13 |
| Est. Completion | 2017-11-30 |
| Phase | Phase 2 |
What the finished NCT02265744 record still lists
NCT02265744 is an interventional study that assigns participants to a tested intervention. The registered 730 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 (449% higher).
The record links to 0 conditions, and to 2 interventions - of which BMS-931699 is the first listed.
NCT02265744 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02265744 about?
NCT02265744 is a clinical study titled "Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus". Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythematosus in male and female adults. Patients who qualify will be randomized to either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the initial 24 weeks of treatme...
What is the current status of trial NCT02265744?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 730 participants. The study started on 2014-11-13. Estimated completion is 2017-11-30.
What interventions are being tested in trial NCT02265744?
The interventions under investigation include: BMS-931699 (DRUG), Placebo matching BMS-931699 (DRUG).
Who is sponsoring clinical trial NCT02265744?
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 NCT02265744's enrollment target sits among peer trials
730 45th of 2000 higher than 1,956 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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