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

Tracking Information
First Submitted Date ICMJE	March 12, 2010
First Posted Date ICMJE	March 26, 2010
Last Update Posted Date	January 4, 2013
Study Start Date ICMJE	March 2010
Actual Primary Completion Date	December 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 24, 2010)	Assessment of safety of CDP7657 as per Adverse Event (AE) reporting [ Time Frame: Day 0 to 119 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01093911 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 24, 2010)	Maximum plasma concentration (Cmax) [ Time Frame: Day 0 to 119 ]; Time corresponding to Cmax (Tmax) [ Time Frame: Day 0 to 119 ]; Terminal elimination half-life (t 1/2) [ Time Frame: Day 0 to 119 ]; Plasma levels of anti-CDP7657 antibodies [ Time Frame: Day 0 to 119 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)
Official Title ICMJE	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.
Brief Summary	To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator)
Condition ICMJE	Immune System Diseases; Autoimmune Diseases; Lupus Erythematosus, Systemic; Skin and Connective Tissue Diseases; Connective Tissue Disease
Intervention ICMJE	Biological: CDP7657 Ascending single doses of CDP7657; Other: Placebo Placebo: 0.9% sodium chloride aqueous solution
Study Arms	Experimental: CDP7657 CDP7657 in dose escalating cohorts Intervention: Biological: CDP7657; Placebo Comparator: Placebo Intervention: Other: Placebo
Publications *	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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: March 24, 2010)	44
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	December 2012
Actual Primary Completion Date	December 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 60 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Belgium, Bulgaria, Germany
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01093911
Other Study ID Numbers ICMJE	SL0013; 2009-013617-10 ( EudraCT Number )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	UCB Pharma
Study Sponsor ICMJE	UCB Pharma
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account	UCB Pharma
Verification Date	January 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP