Autoimmune Diseases, Connective Tissue Disease, Immune System Diseases, Lupus Erythematosus, Systemic, Skin and Connective Tissue Diseases
Conditions
Keywords
Lupus, SLE
Brief summary
To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.
Interventions
BIOLOGICALCDP7657
CDP7657 100 mg/ ml solution 30 mg/ kg initial dose 15 mg/ kg every other week 10 weeks
OTHERPlacebo
Placebo comparator
Sponsors
Biogen
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with Systemic Lupus Erythematosus (SLE)
Exclusion criteria
* Severe neuropsychiatric or severe renal Systemic Lupus Erythematosus (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) during the study | 0 - 28 Weeks |
| Percentage of subjects who withdrew due to an Treatment-emergent Adverse Event (TEAE) during the study | 0 - 28 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration (Cmax) | 0 - 28 Weeks |
| Predose plasma concentration (Ctrough) | 0 - 28 Weeks |
| Area under the concentration-time curve over the dosing interval (AUCτ) | 0 - 28 Weeks |
Countries
Belgium, Bulgaria, Germany, Poland, Romania, Russia, Spain
Outcome results
None listed