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COMPLETED Phase 2

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

NCT01438489 · View on ClinicalTrials.gov ↗

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.

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

55 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 626 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MedImmune, which has 55 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01438489 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01438489?

The interventions under investigation include: Placebo (OTHER), Anifrolumab 300 mg (BIOLOGICAL), Anifrolumab 1000 mg (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01438489?

This trial is sponsored by MedImmune, which has 55 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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