Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)
NCT ID: NCT01093911
Last Updated: 2013-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
44 participants
INTERVENTIONAL
2010-03-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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CDP7657
CDP7657 in dose escalating cohorts
CDP7657
Ascending single doses of CDP7657
Placebo
Placebo
Placebo: 0.9% sodium chloride aqueous solution
Interventions
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CDP7657
Ascending single doses of CDP7657
Placebo
Placebo: 0.9% sodium chloride aqueous solution
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of chronic, recurrent, or recent severe infection
* Significant hematologic abnormalities
* History of cancer, heart failure, renal disease, liver disease or other serious illness
18 Years
60 Years
ALL
Yes
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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6
Leuven, , Belgium
9
Sofia, , Bulgaria
1
Berlin, , Germany
2
Erlangen, , Germany
3
Frankfurt, , Germany
4
Hanover, , Germany
8
Kiel, , Germany
7
Münster, , Germany
Countries
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References
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Tocoian A, Buchan P, Kirby H, Soranson J, Zamacona M, Walley R, Mitchell N, Esfandiari E, Wagner F, Oliver R. First-in-human trial of the safety, pharmacokinetics and immunogenicity of a PEGylated anti-CD40L antibody fragment (CDP7657) in healthy individuals and patients with systemic lupus erythematosus. Lupus. 2015 Sep;24(10):1045-56. doi: 10.1177/0961203315574558. Epub 2015 Mar 16.
Other Identifiers
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2009-013617-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SL0013
Identifier Type: -
Identifier Source: org_study_id
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