Trial · NCT03244059

Belimumab Treatment of Emphysema Patients With Anti-GRP78 Autoantibodies

NCT03244059, Phase 2, Completed, University of Alabama at Birmingham; results first posted 2023-07-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Belimumab Treatment of Emphysema Patients With Anti-GRP78 Autoantibodies. Trials, record NCT03244059. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03244059

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Belimumab Treatment of Emphysema Patients With Anti-GRP78 Autoantibodies
NCT number: NCT03244059
Status: Completed
Phases: Phase 2
Enrollment: 17 participants, actual
Lead sponsor: University of Alabama at Birmingham
Conditions: Chronic Obstructive Pulmonary Disease, Emphysema
Interventions: Belimumab, Placebo
First posted: 2017-08-09
Last updated: 2023-07-18
Results first posted: 2023-07-18

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change of Circulating Anti-GRP78 IgG Levels	Plasma concentrations of the anti-GRP78 autoantibodies will be measured pre-treatment and at end of treatment at 210 days (or when subject withdraws)	Anti-GRP78 IgG is a clinically relevant surrogate biomarker of autoimmunity in pulmonary emphysema patients who have clinically relevant (and quantifiable) autoimmune responses
Secondary	Percent Change of Pneumococcal Polysaccharide-binding Antibodies	Prior to treatment and at end of treatment on day 210 (or the conclusion of treatment if subject withdraws)	Treatment effects on concentrations of pneumococcal polysaccharide-binding antibodies by ELISA
Secondary	Percent Change of Circulating B-cells	Prior to treatment, and at treatment end on day 210 or when subject participation is terminated	Treatment effect on relative percentages of circulating B-cells (CD20+) by flow cytometry
Secondary	Adverse Events	Study start to completion (7 months)	Adverse events will be evaluated according to criteria outlined in the National Cancer Institure (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change of Circulating Anti-GRP78 IgG Levels	Plasma concentrations of the anti-GRP78 autoantibodies will be measured pre-treatment and at end of treatment at 210 days (or when subject withdraws)	Measured as Optical Density (OD) at 405 nM of ELISA. OD values are proportional to autoantibody concentration.	% change	MEAN
SECONDARY	Percent Change of Pneumococcal Polysaccharide-binding Antibodies	Prior to treatment and at end of treatment on day 210 (or the conclusion of treatment if subject withdraws)		Percent change	MEAN
SECONDARY	Percent Change of Circulating B-cells	Prior to treatment, and at treatment end on day 210 or when subject participation is terminated	analyzed as % of CD20+ cells among peripheral blood mononuclear cells	Percent change	MEAN
SECONDARY	Adverse Events	Study start to completion (7 months)		Adverse events	NUMBER

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percent Change of Circulating Anti-GRP78 IgG Levels	Belimumab	-17.0	Standard Error 5.4	% change
Percent Change of Circulating Anti-GRP78 IgG Levels	Placebo	-2.6	Standard Error 5.1	% change
Percent Change of Pneumococcal Polysaccharide-binding Antibodies	Belimumab	-14.1	Standard Error 9.1	Percent change
Percent Change of Pneumococcal Polysaccharide-binding Antibodies	Placebo	-5.0	Standard Error 6.5	Percent change
Percent Change of Circulating B-cells	Belimumab	-12.2	Standard Error 4.9	Percent change
Percent Change of Circulating B-cells	Placebo	-5.0	Standard Error 6.5	Percent change
Adverse Events	Belimumab	10		Adverse events
Adverse Events	Placebo	4		Adverse events

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Specific Aim 1	STARTED	Belimumab	11
Specific Aim 1	STARTED	Placebo	6
Specific Aim 1	COMPLETED	Belimumab	10
Specific Aim 1	COMPLETED	Placebo	6
Specific Aim 1	NOT COMPLETED	Belimumab	1
Specific Aim 1	NOT COMPLETED	Placebo	0
Specific Aim 2	STARTED	Belimumab	11
Specific Aim 2	STARTED	Placebo	6
Specific Aim 2	COMPLETED	Belimumab	10
Specific Aim 2	COMPLETED	Placebo	6

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events26

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Minor self limited	Nervous system disorders	Belimumab	3	10	4
other	Minor self limited	Nervous system disorders	Placebo	0	6	0
other	Minor self limited	Nervous system disorders	Belimumab	1	10	1
other	Minor self limited	Nervous system disorders	Placebo	0	6	0
other	minor adverse event	Metabolism and nutrition disorders	Belimumab	1	10	1
other	minor adverse event	Metabolism and nutrition disorders	Placebo	0	6	0
other	minor adverse event	Gastrointestinal disorders	Belimumab	1	10	1
other	minor adverse event	Gastrointestinal disorders	Placebo	0	6	0
other	minor adverse event	Gastrointestinal disorders	Belimumab	2	10	2
other	minor adverse event	Gastrointestinal disorders	Placebo	0	6	0

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Belimumab	0	10
Total, all-cause mortality	Placebo	0	6
Total, other adverse events	Belimumab	4	10
Total, other adverse events	Placebo	4	6
Total, serious adverse events	Belimumab	4	10
Total, serious adverse events	Placebo	0	6

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Belimumab vs Placebo: deaths from any cause	Trial comparisons
Belimumab vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03244059

GET https://conductscience.org/api/trials/v1/NCT03244059/events?page=2

API reference For AI assistants