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



Status:Completed
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:January 2012
End Date:April 2015

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A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects With 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.


Inclusion Criteria:

- 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 subjects 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

Exclusion Criteria:

- 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

- Subjects with significant hematologic abnormalities
We found this trial at
32
sites
448
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Stockbridge, GA
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436
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Atlanta, GA
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492
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Birmingham, AL
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Charlotte, North Carolina 28207
350
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Charlotte, NC
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274
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Chicago, IL
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6
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Columbus, OH
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430
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Decatur, GA
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844
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Edmond, OK
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991
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Houston, TX
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991
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Houston, TX
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1508
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Idaho Falls, ID
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166
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Indianapolis, IN
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1926
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La Jolla, CA
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1967
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La Palma, CA
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1421
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Las Cruces, NM
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1975
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Long Beach, CA
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1972
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Los Angeles, CA
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508
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Memphis, TN
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993
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Miami, FL
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481
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New York, NY
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747
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Ocala, FL
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792
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Orlando, FL
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1882
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Palm Desert, CA
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821
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Palm Harbor, FL
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371
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Raleigh, NC
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5045
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Rio de Janeiro,
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2094
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San Leandro, CA
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Seattle, WA
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1778
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Spokane, WA
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831
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Tampa, FL
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752
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Tulsa, OK
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1939
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Upland, CA
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