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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01559090 |
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Date of registration:
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19/03/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.
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Scientific title:
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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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Date of first enrolment:
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April 20, 2012 |
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Target sample size:
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17 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01559090 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Japan
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Contacts
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Name:
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Roberta Weiss, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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MedImmune LLC |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: MEDI-546
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Primary Outcome(s)
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Overall Summary of Adverse Events
[Time Frame: Stage I (up to 48 weeks)]
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Secondary Outcome(s)
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Anti-drug Antibody (ADA)
[Time Frame: Stage I (up to Week 48)]
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Pharmacokinetic Parameters of MEDI-546 After Single Dose: AUClast
[Time Frame: Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29]
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Pharmacokinetic Parameters of MEDI-546 After Single Dose: Cmax
[Time Frame: Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29]
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Secondary ID(s)
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D3461C00002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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