NCT04671446: IDEA

Identification of Autoantigens in EGPA and Severe Eosinophilic Asthma

Completed Results posted Last updated 30 January 2025

What this trial tests

trial testing Autoantibody ELISA in Churg-Strauss Syndrome in 120 participants. Completed in 5 May 2024.

Timeline

10 December 2020

Primary endpoint
12 October 2022

5 May 2024

Quick facts

Lead sponsor	Queen Mary University of London
Status	Completed
Study type	OBSERVATIONAL
Enrollment	120
Start date	10 December 2020
Primary completion	12 October 2022
Estimated completion	5 May 2024
Sites	2 locations across United Kingdom

Drugs / interventions tested

• Autoantibody ELISA
• Granulocyte Immunofluorescence

Conditions studied

• Churg-Strauss Syndrome — all drugs for Churg-Strauss Syndrome →
• Eosinophilic Asthma — all drugs for Eosinophilic Asthma →
• Eosinophilic Esophagitis — all drugs for Eosinophilic Esophagitis →
• Eosinophilic Pneumonia — all drugs for Eosinophilic Pneumonia →

Sponsor

Queen Mary University of London

Who can join

18 and older, any sex, with Churg-Strauss Syndrome or Eosinophilic Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number and Percentage of Patients With a Positive Autoantibody ELISA Primary · Baseline, at study entry

Serum tested for novel autoantibodies against candidate auto-antigens by ELISA. Outcome: Positive OD by ELISA (serum samples) to autoantigen panel (MPO, Collagen V, TREM1, IL1R2).

Group	Value	95% CI
Severe Eosinophilic Asthma	19
Healthy Controls	4
EGPA	3
Other Respiratory Conditions	4

Number and Percentage of Patients With Positive Granulocyte Immunofluorescence Secondary · Baseline, at study entry

FITC anti-IgG immunofluorescence with slides of unstimulated/PMA-stimulated neutrophils (serum samples)

Group	Value	95% CI
Severe Eosinophilic Asthma	9
Healthy Controls	1
EGPA	3

Percentage of Total Unique BCR Sequences Being of IgA1 Subclass Secondary · Baseline, at study entry

Peripheral blood B Cell Receptor (BCR) bulkRNA repertoire sequencing

Group	Value	95% CI
Severe Eosinophilic Asthma	0.89	± 0.58
Healthy Controls	0.82	± 0.48
EGPA	1.68	± 1.07

Percentage of Total Unique BCR Sequences Being of IgA2 Subclass Secondary · Baseline, at study entry

Peripheral blood B Cell Receptor (BCR) bulkRNA repertoire sequencing

Group	Value	95% CI
Severe Eosinophilic Asthma	1.33	± 1.18
Healthy Controls	0.85	± 0.48
EGPA	1.59	± 1.23

Percentage of Total Unique BCR Sequences Being of IgG1 Subclass Secondary · Baseline, at study entry

Peripheral blood B Cell Receptor (BCR) bulkRNA repertoire sequencing

Group	Value	95% CI
Severe Eosinophilic Asthma	2.52	± 2.18
Healthy Controls	2.05	± 1.36
EGPA	2.90	± 1.34

Percentage of Total Unique BCR Sequences Being of IgG2 Subclass Secondary · Baseline, at study entry

Peripheral blood B Cell Receptor (BCR) bulkRNA repertoire sequencing

Group	Value	95% CI
Severe Eosinophilic Asthma	7.86	± 9.46
Healthy Controls	3.15	± 1.50
EGPA	8.37	± 9.20

Percentage of Total Unique BCR Sequences Being of IgG3 Subclass Secondary · Baseline, at study entry

Peripheral blood B Cell Receptor (BCR) bulkRNA repertoire sequencing

Group	Value	95% CI
Severe Eosinophilic Asthma	0.60	± 0.55
Healthy Controls	0.69	± 0.79
EGPA	0.68	± 0.58

Percentage of Total Unique BCR Sequences Being of IgG4 Subclass Secondary · Baseline, at study entry

Peripheral blood B Cell Receptor (BCR) bulkRNA repertoire sequencing

Group	Value	95% CI
Severe Eosinophilic Asthma	0.059	± 0.10
Healthy Controls	0.011	± 0.0086
EGPA	0.051	± 0.048

Percentage of Total Unique BCR Sequences Being of IgE Subclass Secondary · Baseline, at study entry

Peripheral blood B Cell Receptor (BCR) bulkRNA repertoire sequencing

Group	Value	95% CI
Severe Eosinophilic Asthma	0.017	± 0.012
Healthy Controls	0.0060	± 0.0029
EGPA	0.039	± 0.040

Sponsor's own description

In this project the investigators will look for auto-antibodies to relevant proteins both in native form and importantly in post-translationally modified forms. Potential modified auto-antigens are eosinophil proteins (analogous to the cytoplasmic neutrophil proteins identified in vasculitides such as Granulomatosis with Polyangiitis (formerly known as Wegener's granulomatosis) and alternatively structural proteins such as collagen V. As well as advancing the understanding of asthma pathology, identifying a serum auto-antibody that could then be used as a clinical blood test, analogous to anti-cyclic citrullinated peptide (CCP) antibodies in rheumatoid arthritis, may revolutionise diagnosis of severe eosinophilic asthma and Eosinophilic Granulomatosis with Polyangiitis (EGPA). There is a considerable burden of undiagnosed severe eosinophilic asthma in part due to difficulties in definitive diagnosis and a diagnostic blood test would help diagnose these patients, allowing them to receive necessary treatment.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. HES and EGPA: Two Sides of the Same Coin.
   Khoury P, Akuthota P, Kwon N, Steinfeld J, et al · · 2023 · cited 21× · PMID 37419574 · DOI 10.1016/j.mayocp.2023.02.013
2. Identification of autoantigens and their potential post-translational modification in EGPA and severe eosinophilic asthma.
   Esposito I, Kontra I, Giacomassi C, Manou-Stathopoulou S, et al · · 2023 · cited 1× · PMID 37334358 · DOI 10.3389/fimmu.2023.1164941