Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)
This study has been completed.
Sponsor:
UCB Pharma
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
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Purpose
To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657
| Condition | Intervention | 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 |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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. |
Resource links provided by NLM:
Further study details as provided by UCB Pharma:
Primary Outcome Measures:
- Assessment of safety of CDP7657 as per Adverse Event (AE) reporting [ Time Frame: Day 0 to 119 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 44 |
| Study Start Date: | March 2010 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093911
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093911
Locations
| 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 | |
Sponsors and Collaborators
UCB Pharma
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
No publications provided
| Responsible Party: | UCB Pharma |
| ClinicalTrials.gov Identifier: | NCT01093911 History of Changes |
| Other Study ID Numbers: | SL0013, 2009-013617-10 |
| Study First Received: | March 12, 2010 |
| Last Updated: | January 3, 2013 |
| Health Authority: | Germany: Paul-Ehrlich-Institut Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by UCB Pharma:
|
Lupus SLE |
Additional relevant MeSH terms:
|
Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic |
ClinicalTrials.gov processed this record on March 03, 2015