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NCT02446899 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 373
- Enrollment target
NCT02446899: Completed Phase 3 study, sponsored by AstraZeneca.
NCT02446899 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 373 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02446899, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 373 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of anifrolumab versus placebo in adult participants with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).
Primary Outcome
Composite endpoint BICLA was defined by meeting all of the following criteria: * Reduction of all baseline British Isles Lupus Assessment Group (BILAG)-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B * No worsening from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), where worsening is defined as an increase from baseline of \>0 points in SLEDAI-2K * N
Interventions
- DRUG Placebo
- BIOLOGICAL Anifrolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 373 participants |
| Start Date | 2015-07-09 |
| Est. Completion | 2018-09-27 |
| Phase | Phase 3 |
What the finished NCT02446899 record still lists
NCT02446899 is an interventional study that assigns participants to a tested intervention. The registered 373 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 (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02446899 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02446899 about?
NCT02446899 is a clinical study titled "Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus". The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of anifrolumab versus placebo in adult participants with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).
What is the current status of trial NCT02446899?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 373 participants. The study started on 2015-07-09. Estimated completion is 2018-09-27.
What interventions are being tested in trial NCT02446899?
The interventions under investigation include: Placebo (DRUG), Anifrolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02446899?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02446899's enrollment target sits among peer trials
373 991st of 2000 higher than 1,010 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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