Actively Recruiting
A Pilot Phase 2 Study of Dupilumab as Add-On Therapy for Hypereosinophilic Syndrome in Patients with Partial Response to Eosinophil-Lowering Biologic Agents
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-11
30
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying hypereosinophilic syndrome (HES), a blood disorder that causes high levels of eosinophils which can damage organs like lungs, skin, intestines, and airways. This trial evaluates the effect of adding dupilumab, an approved biological drug, to current eosinophil-lowering treatments in adults with HES who still have symptoms despite their current therapy. The study aims to assess whether dupilumab can reduce these persistent symptoms while monitoring safety and blood eosinophil levels. Participants will receive dupilumab injections under the skin every 1 or 2 weeks, with dosing based on their specific symptoms and FDA-approved guidelines for related conditions such as asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyposis, or eosinophilic esophagitis. They will continue their current eosinophil-lowering biologic drugs throughout the study. The initial treatment period with dupilumab lasts 24 weeks, and if benefits are seen, participants may continue for another 24 weeks with possible tapering of other background therapies. During up to 48 weeks of participation, individuals will have up to 6 clinic visits and 7 remote visits. They will undergo blood and urine tests, heart function tests, and complete surveys on how HES affects their daily life. Some may have a bone marrow biopsy and additional symptom-specific tests, such as breathing tests for lung symptoms. Researchers will monitor symptom improvement using patient-reported outcome measures and blood eosinophil counts, with a final visit 12 weeks after the last dupilumab dose to assess lasting effects and safety.
CONDITIONS
Brief 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 historic high eosinophil counts on two occasions
- Evidence of organ damage related to eosinophilia not caused by other conditions
- Currently receiving eosinophil-lowering biologic treatment (mepolizumab, reslizumab, or benralizumab) for at least 24 weeks
- Eosinophil count below 0.5 x 10^9/L
- Presence of moderate residual symptoms related to asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyposis, or eosinophilic esophagitis despite treatment
- For those who can become pregnant: use of highly effective contraception or abstinence starting 4 weeks before and during the study plus 12 weeks after
- Participation in NIH protocol 94-I-0079
- Ability to understand and provide informed consent
You will not qualify if you...
- Pregnancy or breastfeeding
- Known allergic reaction to dupilumab or its ingredients
- Fever within 7 days before enrollment
- Use of investigational drugs other than specified biologics within 12 weeks or 4 half-lives
- Known or suspected immune deficiency including HIV infection
- Diagnosis of eosinophilic granulomatosis with polyangiitis
- Changes in eosinophil-active therapies within the past 6 weeks
- Planned major surgery during the study
- Active parasitic infection
- History of cancer 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, history of certain gastrointestinal diseases or surgeries, or esophageal strictures preventing endoscope passage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive add-on therapy with dupilumab along with their existing eosinophil-lowering biologic treatment. The dosing of dupilumab depends on individual residual symptoms and FDA-approved indications. Clinical evaluations and blood tests to measure eosinophil counts are conducted regularly during this period.
Visits every 4 weeks for 24 weeks
Duration - Additional 24 weeks
Participants who remain in clinical remission and maintain low eosinophil counts continue dupilumab therapy with tapering of other background therapies as tolerated.
Visits every 4 weeks for 24 weeks
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.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here