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

Autoimmune Diseases Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01093911
• Other study ID #: SL0013
• Secondary ID: 2009-013617-10
• Status: Completed
• Phase: Phase 1
• First received: March 12, 2010
• Last updated: January 3, 2013
• Start date: March 2010
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-InstitutBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

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

Intervention

Biological:
• CDP7657
Ascending single doses of CDP7657

Other:
• Placebo
Placebo: 0.9% sodium chloride aqueous solution

Locations

Country	Name	City	State
Belgium	6	Leuven
Bulgaria	9	Sofia
Germany	1	Berlin
Germany	2	Erlangen
Germany	3	Frankfurt
Germany	4	Hannover
Germany	8	Kiel
Germany	7	Münster

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of safety of CDP7657 as per Adverse Event (AE) reporting		Day 0 to 119	No
Secondary	Maximum plasma concentration (Cmax)		Day 0 to 119	No
Secondary	Time corresponding to Cmax (Tmax)		Day 0 to 119	No
Secondary	Terminal elimination half-life (t 1/2)		Day 0 to 119	No
Secondary	Plasma levels of anti-CDP7657 antibodies		Day 0 to 119	No