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NCT01438489 · ClinicalTrials.gov registry record · Phase 2

A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus

A Phase 2 study of Systemic Lupus Erythematosus, sponsored by MedImmune.

Completed
Registry status
Phase 2
Development phase
626
Enrollment target
20
Study locations

NCT01438489 is a Phase 2 study of Systemic Lupus Erythematosus that has completed, run by MedImmune. The registered enrollment target is 626 participants, above the 374-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (67% higher). The trial reports 20 study locations across 8 states.

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The verdict

NCT01438489, a Phase 2 study of Systemic Lupus Erythematosus, has completed, sponsored by MedImmune.

COMPLETED
Registry status
Phase 2
Development phase
626 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard of care treatment for SLE.

Conditions Studied

Systemic Lupus Erythematosus

Interventions

  • OTHER Placebo
  • BIOLOGICAL Anifrolumab 300 mg
  • BIOLOGICAL Anifrolumab 1000 mg

Study Locations (20)

California

  • Research Site - La Jolla
  • Research Site - La Palma
  • Research Site - Long Beach
  • Research Site - Los Angeles
  • Research Site - Palm Desert
  • Research Site - San Leandro
  • Research Site - Upland

Florida

  • Research Site - Miami
  • Research Site - Ocala
  • Research Site - Orlando
  • Research Site - Palm Harbor
  • Research Site - Tampa

Georgia

  • Research Site - Atlanta
  • Research Site - Decatur
  • Research Site - Stockbridge

Alabama

  • Research Site - Birmingham

Idaho

  • Research Site - Idaho Falls

Illinois

  • Research Site - Chicago

Indiana

  • Research Site - Indianapolis

New Mexico

  • Research Site - Las Cruces

Trial Details

FieldValue
Enrollment Target 626 participants
Start Date 2012-01
Est. Completion 2015-04
Phase Phase 2

Sponsor

MedImmune

210 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01438489

The ClinicalTrials.gov registry entry for NCT01438489 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 626 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 374-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (67% higher). The listed sponsor is MedImmune, which has 210 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT01438489 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT01438489 about?

NCT01438489 is a clinical study titled "A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus". The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard of care treatment for SLE.

What is the current status of trial NCT01438489?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 626 participants. The study started on 2012-01. Estimated completion is 2015-04.

What conditions does trial NCT01438489 study?

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

What interventions are being tested in trial NCT01438489?

The interventions under investigation include: Placebo (OTHER), Anifrolumab 300 mg (BIOLOGICAL), Anifrolumab 1000 mg (BIOLOGICAL).

Who is sponsoring clinical trial NCT01438489?

This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01438489 being conducted?

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

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.