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



Status:Completed
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 68
Updated:8/22/2018
Start Date:March 28, 2013
End Date:July 18, 2018

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A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus Erythematosus

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

This is an open-label extension study to evaluate long-term safety and tolerability of
intravenous (IV) MEDI-546 in adult subjects with moderately-to-severely active systemic lupus
erythematosus (SLE). Subjects must have completed the qualifying Phase 2 study and meet this
study criteria in order to be eligible.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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 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, SC, 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
We found this trial at
23
sites
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Columbus, OH
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Atlanta, GA
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Birmingham, AL
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Charlotte, North Carolina 28207
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Charlotte, NC
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Chicago, IL
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Houston, TX
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Indianapolis, IN
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La Palma, CA
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Las Cruces, NM
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Long Beach, CA
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Los Angeles, CA
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Memphis, TN
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New York, NY
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Ocala, FL
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Orlando, FL
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Palm Desert, CA
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Raleigh, NC
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Rio de Janeiro,
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Spokane, WA
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Stockbridge, GA
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Tampa, FL
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Tulsa, OK
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Upland, CA
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