Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)
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ClinicalTrials.gov Identifier: NCT01093911 |
Recruitment Status :
Completed
First Posted : March 26, 2010
Last Update Posted : January 4, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Immune System Diseases Autoimmune Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases Connective Tissue Disease | Biological: CDP7657 Other: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 44 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Official Title: | 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. |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: CDP7657
CDP7657 in dose escalating cohorts
|
Biological: CDP7657
Ascending single doses of CDP7657 |
Placebo Comparator: Placebo |
Other: Placebo
Placebo: 0.9% sodium chloride aqueous solution |
- Assessment of safety of CDP7657 as per Adverse Event (AE) reporting [ Time Frame: Day 0 to 119 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093911
Belgium | |
6 | |
Leuven, Belgium | |
Bulgaria | |
9 | |
Sofia, Bulgaria | |
Germany | |
1 | |
Berlin, Germany | |
2 | |
Erlangen, Germany | |
3 | |
Frankfurt, Germany | |
4 | |
Hannover, Germany | |
8 | |
Kiel, Germany | |
7 | |
Münster, Germany |
Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
Responsible Party: | UCB Pharma |
ClinicalTrials.gov Identifier: | NCT01093911 |
Other Study ID Numbers: |
SL0013 2009-013617-10 ( EudraCT Number ) |
First Posted: | March 26, 2010 Key Record Dates |
Last Update Posted: | January 4, 2013 |
Last Verified: | January 2013 |
Lupus SLE |
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |