Safety Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Lupus Nephritis

Baxalta

Status and phase: Terminated; Phase 1

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody

Study type: Interventional

Funder types: Industry

Identifiers

NCT01541670

391001

Details and patient eligibility

About

The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody in subjects with lupus nephritis.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed and dated written informed consent obtained from the subject
• Males and females of age 18 years and older at the time of screening
• Established diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology classification criteria
• Documented renal biopsy evidence of proliferative glomerulonephritis prior to screening
• Urine protein-to-creatinine ratio > 0.5 (mg/mg)

Exclusion criteria

• Any significant health problem other than lupus or lupus nephritis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Open-label Dose-Escalation Arm

Experimental group

Description:

Conducted in an ascending dose manner, subjects will be assigned to single- or multiple-dose administration of the investigational product

Treatment:

Drug: Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody