An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults

Completed · Phase 2

Conditions studied: Lupus Erythematosus, Systemic

In brief

The purpose of this study is to evaluate the long-term safety of anifrolumab (MEDI-546) in adults with moderate to severe active systemic lupus erythematosus (SLE).

Key facts

Study ID

NCT01753193

Run by

MedImmune LLC

People needed

218

Starts

2013-03-28

Expected to finish

2018-07-18

Last updated by the study team

2019-07-31

Who can join

Age: 18 and older, up to 68. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be willing to use 2 methods of effective contraception
• Must have venous access
• Must be willing to forego participation in other clinical trials for SLE.

You may not qualify if…

• Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
• Major surgery within 8 weeks before signing informed consent form (ICF)
• Elective major surgery planned during the study period
• Concomitant Medications within the last 12 weeks: Azathioprine > 200 mg/day, Mycophenolate mofetil/mycophenolic acid > 2.0 g/day, oral, subcutaneous, or intramuscular methotrexate > 25 mg/week
• A live or attenuated vaccine within 4 weeks of signing the ICF
• Bacillus of Calmette and Guérin (BCG) vaccine within 1 year of ICF

Where it is running

• Research Site — La Palma, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Palm Desert, California, United States
• Research Site — Upland, California, United States
• Research Site — Ocala, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Stockbridge, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Las Cruces, New Mexico, United States
• Research Site — New York, New York, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Raleigh, North Carolina, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Tulsa, Oklahoma, United States
• Research Site — Memphis, Tennessee, United States
• Research Site — Houston, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — Spokane, Washington, United States
• Research Site — Rio de Janeiro, Brazil
• Research Site — São Paulo, Brazil
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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