NCT01541670TerminatedPhase 1
A Study to Assess the Safety and Tolerability of Anti-MIF Antibody in Subjects With Lupus Nephritis
Baxalta now part of Shire23 sites in 5 countries4 target enrollmentStarted: November 28, 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Enrollment
- 4
- Locations
- 23
- Primary Endpoint
- Number of subjects experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality
Study Overview
Brief Summary
The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody in subjects with lupus nephritis.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Open-label Dose-Escalation Arm
Experimental
Conducted in an ascending dose manner, subjects will be assigned to single- or multiple-dose administration of the investigational product
Intervention: Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody (Drug)
Outcomes
Primary Outcomes
Number of subjects experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality
Time Frame: Week 21
Secondary Outcomes
- Plasma pharmacokinetic parameters(Week 21)
Investigators
Study Sites (23)
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