30 Participants Needed

Dupilumab for Hypereosinophilic Syndrome

EA
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Overseen ByAmy D Klion, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Must be taking: Mepolizumab, Reslizumab, Benralizumab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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

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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

Participation in NIH protocol 94-I-0079 (Activation and function of eosinophils in conditions with blood or tissue eosinophilia)
I have been diagnosed with HES, have high eosinophil counts without other causes, and signs of organ damage.
I have been on eosinophil-lowering medication for at least 6 months.
See 4 more

Exclusion Criteria

I have not had a fever or flu-like illness in the last week.
Pregnancy or lactation
Known allergic reaction to dupilumab or any of the excipients in Dupixent(TM)
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive dupilumab in addition to their current eosinophil-lowering biologic therapy for 24 weeks. Dosing varies based on residual symptoms.

24 weeks
6 visits (in-person), 7 visits (remote)

Extended Treatment

Participants who respond well to treatment continue dupilumab for an additional 24 weeks with tapering of background therapy.

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

12 weeks
1 visit (in-person)

Treatment Details

Interventions

  • Dupilumab
Trial Overview The trial is testing the effectiveness of adding dupilumab to existing treatments for HES. Over a period of up to 48 weeks, participants will receive injections alongside their standard medication and attend clinic and remote visits.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Dupilumab in addition to mepolizumab, reslizumab, or benralizumab (at least 24 but up to 48 weeks)Experimental Treatment1 Intervention
Dosing for an individual will be determined based on the nature of their residual symptoms and the FDA-approved dosing for that indication. Patients will self-administer using pre-filled syringes with needle shield or pre-filled pens. Patients with asthma and/or atopic dermatitis will receive a loading dose of 600 mg subcutaneously (followed by 300 mg SC every 2 weeks. Patients with Chronic Rhinosinusitis with Nasal Polyposis will not receive a loading dose and will be treated with 300 mg subcutaneously every 2 weeks. Patients with Eosinophilic Esophagitis will not receive a loading dose of 600 mg subcutaneously and will be treated with 300 mg subcutaneously weekly. Patients who meet criteria for more than one indication will be treated with the higher dose.

Dupilumab is already approved in United States, European Union for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Dupixent for:
  • Atopic dermatitis
  • Asthma
  • Chronic rhinosinusitis with nasal polyps
  • Eosinophilic esophagitis
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Dupixent for:
  • 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

Trials
3,361
Recruited
5,516,000+

Findings from Research

In a study of 21 patients with chronic rhinosinusitis with nasal polyps (CRSwNP) undergoing dupilumab therapy, 19% developed hypereosinophilia (HE), but no cases of hypereosinophilic syndrome were reported, indicating that HE is generally benign in this context.
The study proposes a management flowchart for HE during dupilumab treatment, suggesting that HE levels below 3โ€‰ร—โ€‰10^9/L can be monitored without intervention, while levels above this threshold may require short-term corticosteroid therapy to prevent potential organ involvement.
Hypereosinophilia management in patients with type 2 chronic rhinosinusitis treated with dupilumab: preliminary results.Vinciguerra, A., Rampi, A., Yacoub, MR., et al.[2022]
A 76-year-old male patient with hypereosinophilic dermatitis (HED) showed a significant reduction in eosinophil levels from 20.7% to 4.1% after 8 weeks of treatment with dupilumab, along with complete relief from severe itching.
After 6 months of dupilumab treatment, the patient remained relapse-free for 17 months without any reported adverse events, suggesting that dupilumab may be a safe and effective long-term treatment option for HED.
Hypereosinophilic Dermatitis: Successful Treatment with Dupilumab.Wu, C., Zhang, J., Zhao, Y.[2023]
Dupilumab is an effective treatment for chronic rhinosinusitis with polyposis (CRSwNP), showing significant improvements in patients' subjective disease burden and objective measures, regardless of specific disease characteristics like aspirin exacerbated respiratory disease (AERD) or elevated eosinophil levels.
In a study of 75 patients, dupilumab therapy was reported to be more effective than functional endoscopic sinus surgery (FESS) in certain cases, indicating that some patients may benefit more from dupilumab than from surgical intervention.
Subgroups in the treatment of nasal polyposis with dupilumab: A retrospective study.Bertlich, M., Freytag, S., Dombrowski, T., et al.[2023]

References

Hypereosinophilia management in patients with type 2 chronic rhinosinusitis treated with dupilumab: preliminary results. [2022]
Hypereosinophilic Dermatitis: Successful Treatment with Dupilumab. [2023]
Subgroups in the treatment of nasal polyposis with dupilumab: A retrospective study. [2023]
Hypereosinophilic syndrome with cutaneous manifestations successfully treated with Dupilumab as a sole agent: A case report. [2023]
Early increase in eosinophil count may predict long-term hypereosinophilia during dupilumab treatment: a 2-year observational study. [2023]
Safety update: dupilumab and ocular adverse reactions. [2022]
Eosinophilia Induced by Blocking the IL-4/IL-13 Pathway: Potential Mechanisms and Clinical Outcomes. [2022]
Dupilumab: First Global Approval. [2022]
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