NCT01764594

Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus

A Multicenter, Investigator- and Subject-Blind, Randomized, Placebo-Controlled, Parallel-Group, Repeat-Dose Study to Evaluate the Effect of CDP7657 in Subjects With Active Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	CDP7657	CDP7657 100 mg/ ml solution 30 mg/ kg initial dose 15 mg/ kg every other week 10 weeks
OTHER	Placebo	Placebo comparator

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-01-09
• Last updated: 2015-07-16

Locations

21 sites across 7 countries: Belgium, Bulgaria, Germany, Poland, Romania, Russia, Spain