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

UCB

Status and phase: Completed; Phase 1

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

Treatments: Other: Placebo; Biological: CDP7657

Study type: Interventional

Funder types: Industry

Identifiers

NCT01093911

2009-013617-10 (EudraCT Number)

SL0013

Details and patient eligibility

About

To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657

Enrollment: 44 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

44 participants in 2 patient groups, including a placebo group

CDP7657

Experimental group

Description:

CDP7657 in dose escalating cohorts

Treatment:

Biological: CDP7657

Placebo

Placebo Comparator group

Treatment:

Other: Placebo