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Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01093911
First received: March 12, 2010
Last updated: January 3, 2013
Last verified: January 2013
History of Changes

March 12, 2010
January 3, 2013
March 2010
December 2012   (final data collection date for primary outcome measure)
Assessment of safety of CDP7657 as per Adverse Event (AE) reporting [ Time Frame: Day 0 to 119 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01093911 on ClinicalTrials.gov Archive Site
  • Maximum plasma concentration (Cmax) [ Time Frame: Day 0 to 119 ] [ Designated as safety issue: No ]
  • Time corresponding to Cmax (Tmax) [ Time Frame: Day 0 to 119 ] [ Designated as safety issue: No ]
  • Terminal elimination half-life (t 1/2) [ Time Frame: Day 0 to 119 ] [ Designated as safety issue: No ]
  • Plasma levels of anti-CDP7657 antibodies [ Time Frame: Day 0 to 119 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)
A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity and to Explore the Pharmacodynamics of CDP7657 Administered in Healthy Subjects and in SLE Patients.
To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
  • Immune System Diseases
  • Autoimmune Diseases
  • Lupus Erythematosus, Systemic
  • Skin and Connective Tissue Diseases
  • Connective Tissue Disease
  • Biological: CDP7657
    Ascending single doses of CDP7657
  • Other: Placebo
    Placebo: 0.9% sodium chloride aqueous solution
  • Experimental: CDP7657
    CDP7657 in dose escalating cohorts
    Intervention: Biological: CDP7657
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy Volunteers and subjects with SLE

Exclusion Criteria:

  • Severe neuropsychiatric or severe renal SLE
  • History of chronic, recurrent, or recent severe infection
  • Significant hematologic abnormalities
  • History of cancer, heart failure, renal disease, liver disease or other serious illness
Both
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium,   Bulgaria,   Germany
 
NCT01093911
SL0013, 2009-013617-10
No
Not Provided
Not Provided
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP