Actively Recruiting
Dupilumab as Add-On Therapy for Hypereosinophilic Syndrome With Partial Clinical Response to Eosinophil-Depleting Biologic Agents
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-11
30
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Dupilumab as Add-On Therapy for Hypereosinophilic Syndrome With Partial Clinical Response to Eosinophil-Depleting Biologic Agents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Documented diagnosis of hypereosinophilic syndrome with a history of high eosinophil counts and organ damage
- Currently treated with an eosinophil-lowering biologic (mepolizumab, reslizumab, or benralizumab) for at least 24 weeks
- Absolute eosinophil count below 0.5x10^9/L
- Persistent moderate symptoms related to asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyposis, or eosinophilic esophagitis
- For those who can become pregnant: use of highly effective contraception or sexual abstinence starting 4 weeks before and continuing during the study and for 12 weeks after
- Participation in NIH protocol 94-I-0079
- Ability to understand and sign informed consent
You will not qualify if you...
- Pregnancy or lactation
- Known allergic reaction to dupilumab or its components
- Fever within 7 days before enrollment
- Use of investigational drugs other than specified biologics within 12 weeks or 4 half-lives
- Known or suspected immunodeficiency, including HIV
- Diagnosis of eosinophilic granulomatosis with polyangiitis
- Change in eosinophil-active therapy within the past 6 weeks
- Planned major surgery during the study
- Active parasitic infection
- History of malignancy within 5 years, except certain skin or cervical cancers
- Any condition posing undue risk as judged by the investigator
- For eosinophilic gastrointestinal disease: active Helicobacter pylori infection, certain gastrointestinal diseases or surgeries, or esophageal strictures preventing endoscope passage
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
A
Amy D Klion, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
1
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