Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus

Phase 1CompletedNCT01764594

UCB Pharma24 enrolled

Overview

To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

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

Interventions

CDP7657BIOLOGICAL

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

PlaceboOTHER

Placebo comparator

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (21)

102

Brussels, Belgium

101

Leuven, Belgium

203

Plovidv, Bulgaria

Outcomes

Primary Outcomes

Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) during the study

Time frame: 0 - 28 Weeks

Percentage of subjects who withdrew due to an Treatment-emergent Adverse Event (TEAE) during the study

Time frame: 0 - 28 Weeks

Secondary Outcomes

Maximum plasma concentration (Cmax)

Time frame: 0 - 28 Weeks

Predose plasma concentration (Ctrough)

Time frame: 0 - 28 Weeks

Area under the concentration-time curve over the dosing interval (AUCτ)

Time frame: 0 - 28 Weeks

Data from ClinicalTrials.gov

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