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NCT03244059 · ClinicalTrials.gov registry record · Phase 2

Belimumab Treatment of Emphysema Patients With Anti-GRP78 Autoantibodies

A Phase 2 study of Chronic Obstructive Pulmonary Disease and Emphysema, sponsored by University of Alabama at Birmingham.

Completed
Registry status
Phase 2
Development phase
17
Enrollment target
1
Study location

NCT03244059 is a Phase 2 study of Chronic Obstructive Pulmonary Disease and Emphysema that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 17 participants, below the 1,754-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03244059, a Phase 2 study of Chronic Obstructive Pulmonary Disease and Emphysema, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
Phase 2
Development phase
17 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DRUG Placebo
  • BIOLOGICAL Belimumab

Study Locations (1)

Alabama

  • UAB Lung Health Center - Birmingham

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2018-08-09
Est. Completion 2022-04-01
Phase Phase 2

Sponsor

University of Alabama at Birmingham

1,160 total trials

What the Registry Record Tells You About NCT03244059

The ClinicalTrials.gov registry entry for NCT03244059 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,754-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (99% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03244059 reports 1 study location spanning 1 distinct geographic area - top geographies include Alabama.

Frequently Asked Questions

What is clinical trial NCT03244059 about?

NCT03244059 is a clinical study titled "Belimumab Treatment of Emphysema Patients With Anti-GRP78 Autoantibodies". 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...

What is the current status of trial NCT03244059?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2018-08-09. Estimated completion is 2022-04-01.

What conditions does trial NCT03244059 study?

This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease, Emphysema.

What interventions are being tested in trial NCT03244059?

The interventions under investigation include: Placebo (DRUG), Belimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT03244059?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03244059 being conducted?

This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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