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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01093911
Recruitment Status : Completed
First Posted : March 26, 2010
Last Update Posted : January 4, 2013
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Description
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Brief Summary:
To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657

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 Design
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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

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of safety of CDP7657 as per Adverse Event (AE) reporting [ Time Frame: Day 0 to 119 ]

Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: Day 0 to 119 ]
  2. Time corresponding to Cmax (Tmax) [ Time Frame: Day 0 to 119 ]
  3. Terminal elimination half-life (t 1/2) [ Time Frame: Day 0 to 119 ]
  4. Plasma levels of anti-CDP7657 antibodies [ Time Frame: Day 0 to 119 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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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
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by UCB Pharma:
Lupus
SLE
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases