Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus
This trial has been completed.
|Condition||systemic lupus erythematosus|
|Start date||April 2012|
|End date||August 2014|
|Trial size||20 participants|
|Trial identifier||NCT01559090, D3461C00002|
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Chiba-shi, Japan||Research Site||completed|
|Chuo-ku, Japan||Research Site||completed|
|Ota-ku, Japan||Research Site||completed|
|Sendai-shi, Japan||Research Site||completed|
|Shimotsuke-shi, Japan||Research Site||completed|
|Shinjuku-ku, Japan||Research Site||completed|
|Intervention model||parallel assignment|
Description of the safety profile for MEDI-546 in terms of adverse events, vital signs (body temperature, blood pressure, pulse rate and respiratory rate) and clinical laboratory assessments and electrocardiograms.
time frame: From baseline up to Day 422 at Stage I, From baseline up to Day 1178 at Stage II
Description of the PK profile for MEDI-546 in terms of peak plasma concentration (Cmax), time to peak concentration (tmax), area under concentration curve (AUC) and terminal phase half-life (t1/2)
time frame: Stage I: predose/30 min post dose of Day1 and 337, predose of Day2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 338, 344, 351, 365, 393 and 422. Stage II: predose of Day1, 85, 169, 253, 337, 505, 673, 841, 1009, 1093, 1121 and 1178
Evaluation of the pharmacodynamics of MEDI-546 by assessing the impact on the type I interferon gene signature score.
time frame: Stage I: Day1, 29, 85, 141, 169, 253, 337, 365, 393 and 422. Stage II: Day1, 85, 169, 253, 337, 505, 673, 841, 1009, 1093, 1121 and 1178
Evaluation of Anti-drug antibody by assessing the number and percentage of patients developing detectable anti-MEDI-546 antibodies.
time frame: Stage I: Day1, 85, 141, 169, 253, 337, 365, 393 and 422. Stage II: Day1, 85, 169, 253, 337, 505, 673, 841, 1009, 1093, 1121 and 1178
All participants from 18 years up to 65 years old.
Inclusion Criteria: - Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE. - Weight greater than or equal to 40.0 kg. - Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing treatment or observation for ≥ 24 weeks prior to screening. - Currently receiving stable dose of oral prednisone and/or antimalarials/immunosuppressives. - Active moderate to severe SLE disease based on SLE disease activity score. Exclusion Criteria: - Active severe or unstable neuropsychiatric SLE. - Active severe SLE-driven renal disease or unstable renal disease. - Clinically significant active infection including ongoing and chronic infections. - Known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus infection or splenectomy that predisposes the subject to infection. - Confirmed positive tests for hepatitis B or positive test for hepatitis C.
|Official title||A Phase 2, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Intravenous Dose of MEDI-546, a Human Monoclonal Antibody Directed Against Type I Interferon Receptor (IFNAR), in Japanese Subjects With Active Systemic Lupus Erythematosus (SLE)|
|Description||A phase 2, multicenter, open-label, dose-escalation study to evaluate the safety and tolerability of intravenous dose of MEDI-546, a human monoclonal antibody directed against type I interferon receptor (IFNAR), in Japanese subjects with active systemic lupus erythematosus (SLE)|
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