drugset / Trial / NCT03244059

Belimumab Treatment of Emphysema Patients With Anti-GRP78 Autoantibodies

NCT03244059

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is intended to be an initial "proof-of-concept" study to show feasibility, validate assays and approaches, and explore dosing and safety of belimumab in pulmonary emphysema patients who have clinically relevant (and quantifiable) autoimmune responses. The primary goal is to determine effects of belimumab on levels of autoantibodies against glucose regulated protein 78 (GRP78) among patients with pulmonary emphysema attributable to cigarette smoking. The investigators hypothesize that belimumab treatment will safely reduce circulating levels of autoantibodies that are associated with emphysema, and comorbidities of this lung disease, including atherosclerosis.

Timeline

Start
2018-08-09
Primary completion
2022-04-01
Completion
2022-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Belimumab Monoclonal antibody 10 mg/kg Intravenous

Indications