CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Autoantibody ELISA +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04671446
NCT04671446N/ACompleted

Identification of Autoantigens and Their Potential Post-translational Modification in EGPA and Severe Eosinophilic Asthma

Queen Mary University of London·observational·Posted Dec 17, 2020·Updated Jan 30, 2025

In Brief

An observational study evaluating Autoantibody ELISA and Granulocyte Immunofluorescence for Churg-Strauss Syndrome and 3 related conditions. Completed, enrolled 120 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 17, 2020
Enrollment StartDec 10, 2020
Primary CompletionOct 12, 2022
Study CompletionMay 5, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.5 years ago

Interventions

Autoantibody ELISAother

Serum will be tested for novel autoantibodies against candidate auto-antigens by ELISA, such as those previously identified as of importance (e.g. eosinophil peroxidase, EPX) and also novel candidate proteins specific to eosinophils as identified by FANTOM5 geneset analysis.

Granulocyte Immunofluorescenceother

The presence of auto-antibodies in patient serum to inactive and activated neutrophils / eosinophils, with and without post-translational modification, will be examined by indirect immunofluorescence.