At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Proof-of-concept Randomized, Double-blind, Phase IIa Study to Show Feasibility, Validate Assays and Approaches, and Explore Dosing and Safety of Belimumab in Pulmonary Emphysema Patients
In Brief
A Phase 2 clinical trial evaluating Belimumab and Placebo for Chronic Obstructive Pulmonary Disease and Emphysema. Completed, enrolled 17 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Belimumab is an anti-BLyS (B-lymphocyte stimulating factor) agent administered by infusion.
An identically appearing placebo infusion.