A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.
NCT ID: NCT01031836
Last Updated: 2018-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2009-11-25
2016-07-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MEDI-545 1.0 mg/kg
Cohort 1
MEDI-545
Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses.
MEDI-545 3.0 mg/kg
Cohort 2
MEDI-545
Stage I: MEDI-545 3.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 3.0 mg/kg IV once every 2 weeks for a total of 79 doses
MEDI-545 10.0 mg/kg
Cohort 3
MEDI-545
Stage I: MEDI-545 10.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 10.0 mg/kg IV once every 2 weeks for a total of 79 doses.
MEDI-545 100 mg
Cohort 4
MEDI-545
Stage I: MEDI-545 100 mg SC, on Day 1 and weekly or once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 100 mg SC once every 2 weeks for a total of 79 doses.
MEDI-545 600 mg
Cohort 5
MEDI-545 600
Stage I: MEDI-545 600 mg IV once every 4 weeks from Day 1 for a total of 8 doses.
Stage II: MEDI-545 600 mg IV once every 4 weeks for a total of 40 doses.
MEDI-545 1,200 mg
Cohort 6
MEDI-545
Stage I: MEDI-545 1,200 mg IV once every 4 weeks from Day 1 for a total of 8 doses.
Stage II: MEDI-545 1,200 mg IV once every 4 weeks for a total of 40 doses
Interventions
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MEDI-545
Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses.
MEDI-545
Stage I: MEDI-545 3.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 3.0 mg/kg IV once every 2 weeks for a total of 79 doses
MEDI-545
Stage I: MEDI-545 10.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 10.0 mg/kg IV once every 2 weeks for a total of 79 doses.
MEDI-545
Stage I: MEDI-545 100 mg SC, on Day 1 and weekly or once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 100 mg SC once every 2 weeks for a total of 79 doses.
MEDI-545
Stage I: MEDI-545 1,200 mg IV once every 4 weeks from Day 1 for a total of 8 doses.
Stage II: MEDI-545 1,200 mg IV once every 4 weeks for a total of 40 doses
MEDI-545 600
Stage I: MEDI-545 600 mg IV once every 4 weeks from Day 1 for a total of 8 doses.
Stage II: MEDI-545 600 mg IV once every 4 weeks for a total of 40 doses.
Eligibility Criteria
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Inclusion Criteria
* Have positive antinuclear antibody test (ANA) at ≥1:80 serum dilute in the past or at screening
* Have at least 1 system with a score of A or 2 systems with a score of B on the BILAG index at screening, or have a SELENA-SLEDAI score ≥6
Exclusion Criteria
* Have received the following medications within 28 days before Visit 2 (Day 1):
* Systemic cyclophosphamide at any dose
* Cyclosporine at any dose
* Tacrolimus at any dose
* Thalidomide at any dose
* Mycophenolate mofetil \>2 g/day
* Methotrexate \>15 mg/week
* Azathioprine \>2 mg/kg/day
* Women who have a positive pregnancy test (serum hCG) at Visit 1
20 Years
130 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Tsutomu Takeuchi
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine School of Medicine Keio University
Yoshiya Tanaka
Role: PRINCIPAL_INVESTIGATOR
The University Hospital, University of Occupational and Environmental Health, Japan
Locations
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Research Site
Chiba, , Japan
Research Site
Fukuoka, , Japan
Research Site
Kanazawa, , Japan
Research Site
Kawagoe-shi, , Japan
Research Site
Kitakyushu-shi, , Japan
Research Site
Sapporo, , Japan
Research Site
Shinjuku-ku, , Japan
Countries
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Other Identifiers
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D2800C00001
Identifier Type: -
Identifier Source: org_study_id
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