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Monoclonal Antibodies

Dupilumab for Hypereosinophilic Syndrome

Bethesda, MD

Phase 2

Recruiting

Led By Amy D Klion, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >=18 years

Documented diagnosis of HES with historic AEC>1.5x10^9/L on two occasions, no secondary etiology for the eosinophilia despite careful clinical evaluation, and evidence of end organ damage

Must not have

Known diagnosis of eosinophilic granulomatosis with polyangiitis

Known or suspected acquired or inborn immunodeficiency disorder, including HIV infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 4, 12 and 24 weeks.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a drug called dupilumab, along with other medications, in adults with a blood disorder called hypereosinophilic syndrome (HES). People who are already taking

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Dupilumab may cause injection site reactions, eye problems such as dryness or irritation, joint pain, cold sores in your mouth or on your lips, and allergic reactions that can include rash or swelling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with HES, have high eosinophil counts without other causes, and signs of organ damage.

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I have been on eosinophil-lowering medication for at least 6 months.

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I still have symptoms after 6 months of treatment for my eosinophil-related condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with eosinophilic granulomatosis with polyangiitis.

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I have an immune system disorder, such as HIV.

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I have an eosinophilic gastrointestinal disease but no active Helicobacter pylori infection or history of specific GI conditions or surgeries.

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I am expecting to undergo a major surgery during the study.

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I have an active parasitic infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 4, 12 and 24 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 4, 12 and 24 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 4, 12 and 24 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical improvement on dupilumab therapy as assessed by HES-MBS (HES-most bothersome symptom) and HES-SI (HES-Symptom Inventory).

Secondary study objectives

Incidence of new or worsening symptoms or signs attributable to eosinophilia requiring therapeutic intervention.

Peripheral blood absolute eosinophil counts.

Proportion of patients who maintain an eosinophil count below 0.5 x 10^9/L.

Side effects data

From 2023 Phase 4 trial • 40 Patients • NCT04203797

Cough

Injection site erythema

Rhinitis

Asthma

Sinus pain

Immunisation reaction

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Dupilumab 300 mg Q2W

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

dupilumab

2023

Completed Phase 4

~700

0 / 9Eligibility criteria met