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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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7 April 2015 |
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Main ID: |
NCT02391259 |
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Date of registration:
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06/01/2015 |
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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 the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus
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Scientific title:
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Randomized, Multicenter, Double-Blind, Placebo-Controlled, Rising Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus |
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Date of first enrolment:
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November 2006 |
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Target sample size:
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57 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02391259 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United Kingdom
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United States
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Contacts
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Name:
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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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Amgen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of SLE with positive ANA
- Stable disease with no change in SLE therapy within the previous 30 days
- BMI from 18 to 38 kg/m2
Exclusion Criteria:
- Have had signs or symptoms of a viral, bacterial or fungal infection within 30 days
of study randomization
- Evidence of renal disease or liver disease
- Any history of granulomatous disease including autoimmune granulomatous vasculitis
and sarcoidosis
- Prior administration of any other biologic that primarily targets the immune system
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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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: AMG 557
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Drug: Placebo
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Primary Outcome(s)
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Safety and tolerability
[Time Frame: From 29 days to 169 days]
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Secondary Outcome(s)
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Pharmacokinetic profile of AMG 557 including Tmax, AUClast and Cmax
[Time Frame: From 29 days to 169 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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