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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: Completed Phase 2 study of Chronic Obstructive Pulmonary Disease and Emphysema, sponsored by University of Alabama at Birmingham.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Anti-GRP78 IgG is a clinically relevant surrogate biomarker of autoimmunity in pulmonary emphysema patients who have clinically relevant (and quantifiable) autoimmune responses
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Belimumab
Study Locations (1)
Alabama
- UAB Lung Health Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2018-08-09 |
| Est. Completion | 2022-04-01 |
| Phase | Phase 2 |
What the finished NCT03244059 record still lists
NCT03244059 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,754-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Chronic Obstructive Pulmonary Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03244059's enrollment target sits among peer trials
17 79th of 86 higher than 8 of 86 other Chronic Obstructive Pulmonary Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Obstructive Pulmonary Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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