A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
Public ClinicalTrials.gov record NCT01438489. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects With Systemic Lupus Erythematosus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01438489
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 626 participants
Conditions and interventions
Conditions
Interventions
- Anifrolumab 300 mg Biological
- Anifrolumab 1000 mg Biological
- Placebo Other
Biological · Other
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2012 (Type not available)
- Primary completion
- Apr 2015 (Actual)
- Completion
- Apr 2015 (Actual)
- Last update posted
- Oct 7, 2016
2012 – 2015
United States locations
- U.S. sites
- 30
- U.S. states
- 15
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Birmingham | Alabama | — | — |
| Research Site | La Jolla | California | — | — |
| Research Site | La Palma | California | — | — |
| Research Site | Long Beach | California | — | — |
| Research Site | Los Angeles | California | — | — |
| Research Site | Palm Desert | California | — | — |
| Research Site | San Leandro | California | — | — |
| Research Site | Upland | California | — | — |
| Research Site | Miami | Florida | — | — |
| Research Site | Ocala | Florida | — | — |
| Research Site | Orlando | Florida | — | — |
| Research Site | Palm Harbor | Florida | — | — |
| Research Site | Tampa | Florida | — | — |
| Research Site | Atlanta | Georgia | — | — |
| Research Site | Decatur | Georgia | — | — |
| Research Site | Stockbridge | Georgia | — | — |
| Research Site | Idaho Falls | Idaho | — | — |
| Research Site | Chicago | Illinois | — | — |
| Research Site | Indianapolis | Indiana | — | — |
| Research Site | Las Cruces | New Mexico | — | — |
| Research Site | New York | New York | — | — |
| Research Site | Charlotte | North Carolina | — | — |
| Research Site | Raleigh | North Carolina | — | — |
| Research Site | Columbus | Ohio | — | — |
| Research Site | Edmond | Oklahoma | — | — |
| Research Site | Tulsa | Oklahoma | — | — |
| Research Site | Memphis | Tennessee | — | — |
| Research Site | Houston | Texas | — | — |
| Research Site | Seattle | Washington | — | — |
| Research Site | Spokane | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 49 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01438489, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 7, 2016 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01438489 live on ClinicalTrials.gov.