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

Tracking Information

First Received Date ^ICMJE

March 12, 2010

Last Updated Date

January 3, 2013

Start Date ^ICMJE

March 2010

Primary Completion Date

December 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01093911 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)

Condition ^ICMJE

Immune System Diseases
Autoimmune Diseases
Lupus Erythematosus, Systemic
Skin and Connective Tissue Diseases
Connective Tissue Disease

Intervention ^ICMJE

Biological: CDP7657
Ascending single doses of CDP7657
Other: Placebo
Placebo: 0.9% sodium chloride aqueous solution

Study Arms

Experimental: CDP7657
CDP7657 in dose escalating cohorts

Intervention: Biological: CDP7657
Placebo Comparator: Placebo
Intervention: Other: Placebo

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2012

Primary Completion Date

December 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 60 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Belgium, Bulgaria, Germany

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01093911

Other Study ID Numbers ^ICMJE

SL0013
2009-013617-10 ( EudraCT Number )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

UCB Pharma

Study Sponsor ^ICMJE

UCB Pharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

Information Provided By

UCB Pharma

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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