Phase 2: testing dupilumab for Hypereosinophilic Syndrome
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.
Official registry: https://clinicaltrials.gov/study/NCT06477653 · National Institute of Allergy and Infectious Diseases (NIAID) · enrollment listed as 30
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are dupilumab. The registry lists allocation as randomized. Background: Hypereosinophilic syndrome (HES) is a blood disorder that causes high levels of white blood cells called eosinophils.
They plan to enroll about 30 people at Bethesda. Taking part typically means an infusion or injection of a biologic plus check-ins.
Official title (unrewritten)
A Pilot Phase 2 Study of the Safety and Efficacy of Dupilumab as Add-on Therapy for Hypereosinophilic Syndrome With Partial Clinical Response to Eosinophil-Depleting Biologic Agents
Interventions: dupilumab
Primary outcome (registry wording): Clinical improvement on dupilumab therapy as assessed by HES-MBS (HES-most bothersome symptom) and HES-SI (HES-Symptom Inventory).
Who it is for (from inclusion criteria)
- Ages 18 Years to 99 Years
- To be eligible to participate in this study, an individual must meet all the following criteria:
- Currently receiving treatment with an eosinophil-lowering biologic (mepolizumab, reslizumab, or benralizumab) for a minimum of 24 weeks
- Residual symptoms after a minimum of 24 weeks of eosinophil-lowering biologic therapy with at least 1 most bothersome symptom of moderate severity (HES-SI score \>=2) consistent with \>=1 of the following diagnoses:
- a. asthma, defined as physician-documented asthma requiring medium to high dose inhaled corticosteroids + long-acting beta agonist b. atopic dermatitis, defined as physician-documented chronic or recurrent inflammatory skin disease
- c. CRSwNP, defined as evidence of rhinosinusitis and nasal polyposis on physical examination or imaging
- d. EoE, defined as biopsy-proven esophageal eosinophilia \>15 eosinophils/high power field
- Participation in NIH protocol 94-I-0079 (Activation and function of eosinophils in conditions with blood or tissue eosinophilia)
Who the registry excludes
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation
- Known allergic reaction to dupilumab or any of the excipients in Dupixent(TM)
- Febrile illness within 7 days of enrollment
- Treatment with an investigational drug or other intervention other than mepolizumab, reslizumab, or benralizumab within 12 weeks or 4 half-lives of the investigational agent (whichever is longer)
- Known or suspected acquired or inborn immunodeficiency disorder, including HIV infection
- Known diagnosis of eosinophilic granulomatosis with polyangiitis
Public study contact (from the registry)
Amy D Klion, M.D.
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- National Institutes of Health Clinical Center — Bethesda, Maryland (recruiting)
FAQ about this NCT record
Is NCT06477653 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06477653?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06477653?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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