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NCT02446912 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

A Phase 3 study of Active Systemic Lupus Erythematosus, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
460
Enrollment target
20
Study locations

NCT02446912: Completed Phase 3 study of Active Systemic Lupus Erythematosus, sponsored by AstraZeneca.

NCT02446912 is a Phase 3 study of Active Systemic Lupus Erythematosus that has completed, run by AstraZeneca. The registered enrollment target is 460 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02446912, a Phase 3 study of Active Systemic Lupus Erythematosus, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
460 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).

Primary Outcome

SRI(4) was defined as meeting all of the following criteria: Reduction from baseline of ≥4 points in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) No new organ systems affected, defined by 1 or more British Isles Lupus Assessment Group (BILAG-2004) A or 2 or more BILAG-2004 B items No worsening from baseline in participants lupus disease activity. Worsening was defined as an increase of ≥0.30 points on a 3-point Physician's Global Assessment (PGA) visual analogue scal

Conditions Studied

Active Systemic Lupus Erythematosus

Interventions

  • DRUG Placebo
  • BIOLOGICAL Anifrolumab

Study Locations (20)

Florida

  • Research Site - Aventura
  • Research Site - Miami
  • Research Site - Orlando
  • Research Site - Orlando
  • Research Site - Ormond Beach
  • Research Site - Plantation
  • Research Site - Tampa
  • Research Site - Vero Beach

California

  • Research Site - El Cajon
  • Research Site - La Jolla
  • Research Site - Los Alamitos
  • Research Site - Thousand Oaks

Georgia

  • Research Site - Decatur
  • Research Site - Lawrenceville
  • Research Site - Marietta

Idaho

  • Research Site - Boise
  • Research Site - Idaho Falls

Alabama

  • Research Site - Birmingham

Colorado

  • Research Site - Aurora

Louisiana

  • Research Site - Baton Rouge

Trial Details

FieldValue
Enrollment Target 460 participants
Start Date 2015-06-09
Est. Completion 2018-07-17
Phase Phase 3
AstraZeneca

1,285 total trials

What the finished NCT02446912 record still lists

NCT02446912 is an interventional study that assigns participants to a tested intervention. The registered 460 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 (40% lower).

The record links to 1 condition, with Active Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02446912 names 20 study sites across 7 states, led by Florida, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT02446912 about?

NCT02446912 is a clinical study titled "Efficacy and Safety of Two Doses 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 two doses of anifrolumab versus placebo in adult subjects with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).

What is the current status of trial NCT02446912?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 460 participants. The study started on 2015-06-09. Estimated completion is 2018-07-17.

What conditions does trial NCT02446912 study?

This clinical trial studies the following conditions: Active Systemic Lupus Erythematosus.

What interventions are being tested in trial NCT02446912?

The interventions under investigation include: Placebo (DRUG), Anifrolumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT02446912?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02446912 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT02446912's enrollment target sits among peer trials

460 823rd of 2000 higher than 1,174 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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Related registry views

Source: ClinicalTrials.gov NCT02446912, the US trial registry maintained by the National Library of Medicine. NCT02446912 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.