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NCT06477653 · ClinicalTrials.gov registry record · Phase 2
Dupilumab as Add-On Therapy for Hypereosinophilic Syndrome With Partial Clinical Response to Eosinophil-Depleting Biologic Agents
A Phase 2 study of Hypereosinophilic Syndrome, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06477653 is a Phase 2 study of Hypereosinophilic Syndrome that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 30 participants, below the 129-participant average among 7 other Hypereosinophilic Syndrome trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06477653, a Phase 2 study of Hypereosinophilic Syndrome, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Hypereosinophilic syndrome (HES) is a blood disorder that causes high levels of white blood cells called eosinophils. HES can damage the lungs and airways, intestines, skin, and other organs. The current primary treatment for HES can cause serious side effects. Secondary treatments do not work in all people. Objective: To test an approved drug (dupilumab), combined with other drugs, in people with HES. Eligibility: People aged 18 years and older who take drugs (mepolizumab, reslizumab, or benralizumab) to treat HES. Design: Participants will have up to 6 clinic visits and 7 remote visits in up to 48 weeks. Participants will be screened. They will have blood and urine tests. They will have a test of their heart function. They will take surveys about how HES affects their daily life. Some participants may have a bone marrow biopsy: A sample of tissue and fluid from inside a bone will be removed with a large needle. Participants will have other tests specific to their symptoms. For example, those with symptoms affecting their lungs will have breathing tests. Others may have tests that target symptoms in their sinuses, gastrointestinal tract, or skin. Dupilumab is injected under the skin once every 1 or 2 weeks. Dose and timing will vary among participants. They will be taught how to inject themselves at home between clinic visits. They will take dupilumab plus their current medications for 24 weeks. If the drug is helping them, they will continue taking it for another 24 weeks. Participants will have a final visit 12 weeks after their last dose.
Conditions Studied
Interventions
- BIOLOGICAL dupilumab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-02-05 |
| Est. Completion | 2027-03-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06477653
The ClinicalTrials.gov registry entry for NCT06477653 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 129-participant average among 7 other Hypereosinophilic Syndrome trials with a reported enrollment target (77% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hypereosinophilic Syndrome appearing as the primary indexed condition, and to 1 intervention - of which dupilumab is the first listed.
NCT06477653 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06477653 about?
NCT06477653 is a clinical study titled "Dupilumab as Add-On Therapy for Hypereosinophilic Syndrome With Partial Clinical Response to Eosinophil-Depleting Biologic Agents". Background: Hypereosinophilic syndrome (HES) is a blood disorder that causes high levels of white blood cells called eosinophils. HES can damage the lungs and airways, intestines, skin, and other organs. The current primary treatment for HES can cause serious side effects. Secondary treatments do n...
What is the current status of trial NCT06477653?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2025-02-05. Estimated completion is 2027-03-30.
What conditions does trial NCT06477653 study?
This clinical trial studies the following conditions: Hypereosinophilic Syndrome.
What interventions are being tested in trial NCT06477653?
The interventions under investigation include: dupilumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT06477653?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06477653 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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