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Study Title: A Study to Evaluate Safety and Tolerability of Subcutaneous Doses of MEDI-545 in Subjects With Lupus
Category: Lupus
Currently accepting participants?
Not at this time.
Principal Investigator: Stanford Peng
Study Coordinator: Cora Fix
Phone: 206.223.6835
Email: cora.fix@vmmc.org
What is the A Study to Evaluate Safety and Tolerability of Subcutaneous Doses of MEDI-545 in Subjects With Lupus study?
Study participants will be randomized into one of the following treatment groups after the screening visit:
• SC MEDI-545 100 mg (1 dose); SC placebo on other weeks (12 doses total)
• SC MEDI-545 100 mg every 4 weeks (4 doses total); SC placebo on other weeks (9 doses total)
• SC MEDI-545 100 mg every 2 weeks (7 doses total), SC placebo on other weeks (6 doses total)
• SC MEDI-545 100 mg (13 doses total)
• SC Placebo (13 doses total)
The treatment period is followed by a follow-up period during which safety assessments are continued but study drug is discontinued.
Who can participate?
• >18 years old
• Have a diagnosis of Lupus
• Have received treatment for SLE with antimalarials, oral prednisone or another systemic corticosteroid, mycophenolate mofetil, methotrxate, leflunomide, azathioprine, or dapsone
Study Summary:
The study will take place over about 7 months from screening to the end of the study and will involve 22 study visits. During the screening visit the study doctor will determine if you are eligible to participate in the study. If the study doctor says you can be in the study and you want to be in the study, you will be assigned to a treatment group randomly. At each of the study visits you will receive an injection under the skin of either study drug or placebo as determined by your study group. You will also have blood draws for safety labs and physical exams with the study doctor. After the treatment period (12 weeks) you will enter a follow up period (12 weeks) where you will receive physical exams and safety laboratory testing will be done but no drug will be administered.
Detailed Study Description:
(No information)
Study Design: Interventional, Blinded
Phase of Study: Phase II
Study Type: Interventional
Condition or Study Focus: Lupus
Intervention Type: Drug
Intervention Name: MEDI-545
Gender: Male and Female
Age group: Interventional
Sponsor: MedImmune