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

NCT01438489 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 626

Last updated 2016-10-07

Study results available
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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

Interventions

BIOLOGICAL

Anifrolumab 300 mg

Participants will receive 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.

BIOLOGICAL

Anifrolumab 1000 mg

Participants will receive 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.

OTHER

Placebo

Participants will receive placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Warren Greth, MD · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States
  • Brazil
  • Bulgaria
  • Colombia
  • Czechia
  • Hungary
  • India
  • Mexico
  • Peru
  • Poland
  • Romania
  • South Korea
  • Taiwan
  • Ukraine

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01438489 on ClinicalTrials.gov