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

Phase 1

Completed

• Conditions: Immune System Diseases; Autoimmune Diseases; Lupus Erythematosus, Systemic; Skin and Connective Tissue Diseases; Connective Tissue Disease
• Interventions: Biological: CDP7657; Other: Placebo

• Registration Number: NCT01093911
• Lead Sponsor: UCB Pharma

Brief Summary

To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-12
• Study First Submitted QC: 2010-03-24
• Study First Posted: 2010-03-26
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-03
• Last Update Posted: 2013-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CDP7657	CDP7657	CDP7657 in dose escalating cohorts
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Assessment of safety of CDP7657 as per Adverse Event (AE) reporting	Day 0 to 119

Secondary Outcome Measures

Name	Time	Method
Plasma levels of anti-CDP7657 antibodies	Day 0 to 119
Time corresponding to Cmax (Tmax)	Day 0 to 119
Terminal elimination half-life (t 1/2)	Day 0 to 119
Maximum plasma concentration (Cmax)	Day 0 to 119

Trial Locations

Locations (8)

4; 🇩🇪 Hannover, Germany

1; 🇩🇪 Berlin, Germany

6; 🇧🇪 Leuven, Belgium

9; 🇧🇬 Sofia, Bulgaria

2; 🇩🇪 Erlangen, Germany

3; 🇩🇪 Frankfurt, Germany

8; 🇩🇪 Kiel, Germany

7; 🇩🇪 Münster, Germany