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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: |
NCT01031836 |
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Date of registration:
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11/12/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.
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Scientific title:
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A Phase II, Multicenter, Open-Label, Dose-Escalation Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Japanese Patients Who Have Systemic Lupus Erythematosus (SLE) |
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Date of first enrolment:
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November 25, 2009 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01031836 |
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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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Tsutomu Takeuchi |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Internal Medicine School of Medicine Keio University |
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Name:
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Yoshiya Tanaka |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University Hospital, University of Occupational and Environmental Health, Japan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients must have previously met =4 of the 11 revised ACR 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 prednisone >20 mg/day (or an equivalent dose of another oral
corticosteroid) within 14 days before Visit 2 (Day 1)
- 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
Age minimum:
20 Years
Age maximum:
130 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-545 600
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Drug: MEDI-545
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Primary Outcome(s)
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Number of Participants With Each Category of Adverse Events in Stage I
[Time Frame: Stage I (up to 1 year)]
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Number of Participants in Each Category of Adverse Events (AE) in Stage II
[Time Frame: Stage II (1 year to 3.5 years after first dose)]
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Secondary Outcome(s)
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Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I
[Time Frame: After first dose in Stage I (0 upto 28 days)]
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Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I
[Time Frame: After first dose in Stage I]
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Change From Baseline in 21-gene Signature Fold Change in Stage I
[Time Frame: Stage I]
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Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I
[Time Frame: Stage I]
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AUC0-14 of MEDI-545 After First Dose in Stage I
[Time Frame: After first dose in Stage I]
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Secondary ID(s)
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D2800C00001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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