Dupilumab for Hypereosinophilic Syndrome
Trial Summary
Will I have to stop taking my current medications?
No, you will not have to stop taking your current medications. The trial allows participants to continue their existing treatment with mepolizumab, reslizumab, or benralizumab while adding dupilumab.
What evidence supports the effectiveness of the drug dupilumab for treating hypereosinophilic syndrome?
Dupilumab has shown effectiveness in reducing eosinophil levels and relieving symptoms in patients with hypereosinophilic dermatitis, a subtype of hypereosinophilic syndrome, as well as in a case of idiopathic hypereosinophilic syndrome with skin symptoms. In these cases, patients experienced significant improvement without complications.12345
Is dupilumab generally safe for humans?
Dupilumab is generally considered safe, but it can cause an increase in eosinophils (a type of white blood cell) in some people, which usually resolves on its own. Some cases have reported eye-related side effects and persistent high eosinophil levels, which may lead to conditions like eosinophilic granulomatosis with polyangiitis (EGPA), so monitoring is recommended.12567
How is the drug Dupilumab different from other treatments for hypereosinophilic syndrome?
Dupilumab is unique because it is a monoclonal antibody that targets and blocks the IL-4 and IL-13 signaling pathways, which are involved in allergic and inflammatory responses. Unlike traditional treatments like glucocorticoids, Dupilumab can be used as a single agent and has shown success in reducing eosinophil levels and symptoms without significant adverse effects.12458
What is the purpose of this trial?
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.
Research Team
Amy D Klion, M.D.
Principal Investigator
National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria
Adults over 18 with Hypereosinophilic Syndrome (HES) who are partially responding to current eosinophil-depleting drugs like mepolizumab, reslizumab, or benralizumab. Participants will undergo various tests and must be willing to self-inject dupilumab regularly.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dupilumab in addition to their current eosinophil-lowering biologic therapy for 24 weeks. Dosing varies based on residual symptoms.
Extended Treatment
Participants who respond well to treatment continue dupilumab for an additional 24 weeks with tapering of background therapy.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion.
Treatment Details
Interventions
- Dupilumab
Dupilumab is already approved in United States, European Union for the following indications:
- Atopic dermatitis
- Asthma
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
- Atopic dermatitis
- Asthma
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor