Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus

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: Biological: CDP7657; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01764594

2012-000631-11 (EudraCT Number)

SL0014

Details and patient eligibility

About

To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

24 participants in 2 patient groups, including a placebo group

CDP7657

Experimental group

Description:

CDP7657 100 mg/ ml solution 30 mg/ kg initial dose 15 mg/ kg every other week 10 weeks

Treatment:

Biological: CDP7657

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo