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.
2 other identifiers
interventional
44
3 countries
8
Brief Summary
To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2010
Typical duration for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 12, 2010
CompletedFirst Posted
Study publicly available on registry
March 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJanuary 4, 2013
January 1, 2013
2.8 years
March 12, 2010
January 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of safety of CDP7657 as per Adverse Event (AE) reporting
Day 0 to 119
Secondary Outcomes (4)
Maximum plasma concentration (Cmax)
Day 0 to 119
Time corresponding to Cmax (Tmax)
Day 0 to 119
Terminal elimination half-life (t 1/2)
Day 0 to 119
Plasma levels of anti-CDP7657 antibodies
Day 0 to 119
Study Arms (2)
CDP7657
EXPERIMENTALCDP7657 in dose escalating cohorts
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy Volunteers and subjects with SLE
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (8)
6
Leuven, Belgium
9
Sofia, Bulgaria
1
Berlin, Germany
2
Erlangen, Germany
3
Frankfurt, Germany
4
Hanover, Germany
8
Kiel, Germany
7
Münster, Germany
Related Publications (1)
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.
PMID: 25784719DERIVED
MeSH Terms
Conditions
Interventions
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2010
First Posted
March 26, 2010
Study Start
March 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
January 4, 2013
Record last verified: 2013-01