A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus
NCT ID: NCT01127321
Last Updated: 2014-08-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
44 participants
INTERVENTIONAL
2010-05-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
Placebo
A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
MEDI-570 0.03 MG
A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
MEDI-570 0.03 MG
A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
MEDI-570 0.1 MG
A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
MEDI-570 0.1 MG
A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
MEDI-570 0.3 MG
A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
MEDI-570 0.3 MG
A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
MEDI-570 1 MG
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
MEDI-570 1 MG
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
Interventions
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Placebo
A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
MEDI-570 0.03 MG
A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
MEDI-570 0.1 MG
A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
MEDI-570 0.3 MG
A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
MEDI-570 1 MG
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
Eligibility Criteria
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Inclusion Criteria
* Score greater than or equal to (\>=) 6 points on the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) at Screening
* Ability to complete the study period, including follow-up period through Day 169
* Willingness to forego other forms of experimental treatment during the study.
Exclusion Criteria
* Evidence of active or latent tuberculosis (TB)
* History of primary immunodeficiency
* Evidence of infection at any time with hepatitis B or C virus or human immunodeficiency virus (HIV)-1 or HIV-2, or active infection with hepatitis A, as determined by results of testing at Screening
* History of sepsis or serious, recurrent, chronic infection, current signs and symptoms of clinically significant chronic infection, or recent (within 6 months before Baseline visit) serious infection
* Any history or evidence of opportunistic infection within 6 months of Screening including severe cytomegalovirus (CMV) or herpetic infections (such as disseminated herpes, herpes encephalitis, ophthalmic herpes)
* Receipt of cyclophosphamide (intravenous or oral) within 6 months of Screening
* Have any absolute contraindications to skin punch biopsies, for example, a history of coagulation disorders.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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David Close, PhD
Role: STUDY_DIRECTOR
MedImmune Ltd
Locations
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Research Site
Long Beach, California, United States
Research Site
San Leandro, California, United States
Research Site
Fort Lauderdale, Florida, United States
Research Site
Ocala, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Lansing, Michigan, United States
Research Site
New York, New York, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Columbus, Ohio, United States
Research Site
London, Ontario, Canada
Research Site
Chihuahua City, , Mexico
Research Site
Guadalajara, , Mexico
Research Site
México, , Mexico
Research Site
Lima, , Peru
Research Site
Trujillo, , Peru
Research Site
Cape Town, , South Africa
Research Site
Johannesburg, , South Africa
Countries
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Other Identifiers
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MI-CP209
Identifier Type: -
Identifier Source: org_study_id
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