Longitudinal Study for Eosinophilic Granulomatosis With Polyangiitis

January 21, 2026 updated by: Peter Merkel, University of Pennsylvania

Longitudinal Protocol for Eosinophilic Granulomatosis With Polyangiitis

Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare immune system disorder that causes asthma, an excessive number of eosinophils (a type of white blood cell) in the blood, and the inflammation of blood vessels, or vasculitis. In order to properly treat EGPA, it is critical that the level of disease activity can be determined over the course of the disease. The purpose of this study is to determine new biological markers, or biomarkers, that may be used to assess the severity of this disease in people with EGPA.

Study Overview

Status

Recruiting

Conditions

Detailed Description

EGPA, also known as allergic granulomatosis angiitis, is a systemic vasculitis. EGPA is marked by three distinct symptoms: asthma; eosinophilia, evidenced by an excessive number of eosinophils in the blood and tissues; and vasculitis involving the skin, lungs, nerves, kidneys, and other organs. Nerve involvement may also occur in EGPA, causing pain, tingling, numbness, and muscle wasting in the hands and feet. Because EGPA patients may not show any visible signs of active disease, current methods of monitoring disease progression usually represent a period of extended inflammation and disease activity. Thus, patients may go untreated during a period of undetectable disease when damage might be preventable. This study will use novel scientific methods to identify new biomarkers that can be used to monitor disease activity in EGPA patients. These biomarkers may be used to help direct clinical care for EGPA patients and assist in future drug development.

Study visits will occur every 6 months, or annually. Blood and urine collection will occur at every visit. A physical exam and medical and medication history will at every visit; also, participants will be asked to complete several questionnaires to assess disease activity, health status, and tobacco, alcohol, and drug use.

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Recruiting
        • St. Joseph's Healthcare
        • Contact:
        • Principal Investigator:
          • Nader A. Khalidi, MD
      • Toronto, Ontario, Canada
        • Completed
        • Mount Sinai Hospital
  • Germany
      • Kirchheim unter Teck, Germany, 73230
  • Italy
      • Florence, Italy
        • Recruiting
        • AOU Meyer IRCCS
        • Contact:
        • Principal Investigator:
          • Augusto Vaglio, MD
  • United Kingdom
      • London, United Kingdom, W12 0NN
        • Recruiting
        • Imperial College Healthcare NHS Trust/ Imperial College London
        • Contact:
        • Principal Investigator:
          • Salman Siddiqui
  • United States
    • California
      • San Diego, California, United States, 92122
        • Completed
        • University of California San Diego
    • Colorado
      • Denver, Colorado, United States, 80206
        • Completed
        • National Jewish Health
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Completed
        • Brigham and Women's Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Completed
        • Mayo Clinic
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Completed
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Completed
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • Completed
        • University of Pittsburgh
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Completed
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals with eosinophilic granulomatosis with polyangiitis (Churg-Strauss). Enrollment will be sequential and participants will have disease in various stages and of different duration.

Description

Inclusion Criteria:

Patients with a diagnosis of eosinophilic granulomatosis with polyangiitis are eligible for the study.

Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

- Inability to give informed consent and to sign the consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Discover biomarkers in EGPA capable of measuring disease activity and response to treatment
Time Frame: Study completion
Study completion

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure the predictive value of biomarkers for clinical outcome in EGPA
Time Frame: Study completion.
Study completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

GlaxoSmithKline
AstraZeneca

Investigators

  • Study Chair: Peter A. Merkel, MD, MPH, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

April 14, 2006

First Submitted That Met QC Criteria

April 14, 2006

First Posted (Estimated)

April 18, 2006

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCRC5506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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