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

Completed · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT01438489

Run by

MedImmune LLC

People needed

626

Starts

2012-01-01

Expected to finish

2015-04-01

Last updated by the study team

2016-10-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Fulfills at least 4 of the 11 American College of Rheumatology (ACR) criteria for systemic lupus erythematosus (SLE) including a positive antinuclear antibody (ANA) greater than or equal to 1:80 or elevated anti-double-stranded DNA or anti-Smith antibody at screening
• Pediatric or adult SLE with chronic disease activity for greater than or equal to 24 weeks
• Weight greater than or equal to 40 kg
• Currently receiving stable dose of oral prednisone (or equivalent) less than or equal to 40 mg/day and/or antimalarials/immunosuppressives
• Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI) and British Isles Lupus Assessment Group Index (BILAG) and Physicians Global Assessment
• No evidence of cervical malignancy on Pap smear within 2 years of randomization
• Female participants must be willing to avoid pregnancy
• Negative tuberculosis (TB) test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization.

You may not qualify if…

• Active severe SLE-driven renal disease or unstable renal disease prior to screening
• Active severe or unstable neuropsychiatric SLE
• Clinically significant active infection including ongoing and chronic infections
• History of human immunodeficiency virus (HIV)
• Confirmed Positive tests for hepatitis B or positive test for hepatitis C
• History of severe herpes infection such as herpes encephalitis, ophthalmic herpes, disseminated herpes
• Live or attenuated vaccine within 4 weeks prior to screening
• Participants with significant hematologic abnormalities.

Where it is running

• Research Site — La Jolla, California, United States
• 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 — San Leandro, California, United States
• Research Site — Upland, California, United States
• Research Site — Miami, Florida, United States
• Research Site — Ocala, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Palm Harbor, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Decatur, Georgia, United States
• Research Site — Stockbridge, Georgia, United States
• Research Site — Idaho Falls, Idaho, 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 — Edmond, Oklahoma, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.