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

This study has been completed.

Sponsor:

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

History of Changes

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 Intervention Model: Parallel Assignment Masking: Double Blind (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.

Resource links provided by NLM:

Genetics Home Reference related topics: systemic lupus erythematosus

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

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 ]


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 (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

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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	UCB Pharma
ClinicalTrials.gov Identifier:	NCT01093911 History of Changes
Other Study ID Numbers:	SL0013 2009-013617-10 ( EudraCT Number )
Study First Received:	March 12, 2010
Last Updated:	January 3, 2013

Keywords provided by UCB Pharma:


Lupus SLE

Additional relevant MeSH terms:


Lupus Erythematosus, Systemic Autoimmune Diseases Connective Tissue Diseases Immune System Diseases

ClinicalTrials.gov processed this record on July 19, 2017

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