RECRUITING

Dupilumab as Add-On Therapy for Hypereosinophilic Syndrome With Partial Clinical Response to Eosinophil-Depleting Biologic Agents

Conditions

Hypereosinophilic Syndrome Eosinophil Monoclonal Antibody Clinical Trial Treatment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-01

Study Completion:2027-03-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06477653

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age \>=18 years 2. 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 (histologic evidence of tissue infiltration by eosinophils and/or objective evidence of clinical pathology in any organ system that is temporally associated with eosinophilia and not clearly attributable to another cause) 3. Currently receiving treatment with an eosinophil-lowering biologic (mepolizumab, reslizumab, or benralizumab) for a minimum of 6 months 4. AEC\<0.5x10\^9/L 5. 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: 6. For participants who can become pregnant: sexual abstinence or use of highly effective contraception (i.e., partner vasectomy, bilateral tubal ligation, IUD, progestin implants, and other hormonal methods) starting 4 weeks prior to study drug initiation and agreement to use such a method during study participation and for an additional 12 weeks after the end of study drug administration 7. Participation in NIH protocol 94-I-0079 (Activation and function of eosinophils in conditions with blood or tissue eosinophilia) 8. Ability of subject to understand and the willingness to sign a written informed consent document	1. Pregnancy or lactation 2. Known allergic reaction to dupilumab or any of the excipients in Dupixent(TM) 3. Febrile illness within 7 days of enrollment 4. Treatment with an investigational drug or other intervention other than mepolizumab, reslizumab, or benralizumab within 3 months or 4 half-lives of the investigational agent (whichever is longer). 5. Known or suspected acquired or inborn immunodeficiency disorder, including HIV infection 6. Known diagnosis of eosinophilic granulomatosis with polyangiitis 7. Change in eosinophil-active therapy within the past 6 weeks, including but not limited to topical corticosteroids, leukotriene inhibitors, initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food (in patients with gastrointestinal involvement), and proton pump inhibitors (in patients with gastrointestinal involvement) 8. Planned or anticipated major surgical procedure during the study 9. Active parasitic infection 10. History of malignancy within 5 years, excluding completely treated in situ carcinoma of the cervix, or squamous or basal cell carcinoma of the skin 11. Any condition that, in the investigator s opinion, places the patient at undue risk by participating in the study 1. Active infection with Helicobacter pylori 2. History of achalasia, Crohn s disease, ulcerative colitis, celiac disease, or prior esophageal surgery 3. Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to 10 mm upper endoscope

Inclusion Criteria

Exclusion Criteria

1. Age \>=18 years
2. 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 (histologic evidence of tissue infiltration by eosinophils and/or objective evidence of clinical pathology in any organ system that is temporally associated with eosinophilia and not clearly attributable to another cause)
3. Currently receiving treatment with an eosinophil-lowering biologic (mepolizumab, reslizumab, or benralizumab) for a minimum of 6 months
4. AEC\<0.5x10\^9/L
5. 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:
6. For participants who can become pregnant: sexual abstinence or use of highly effective contraception (i.e., partner vasectomy, bilateral tubal ligation, IUD, progestin implants, and other hormonal methods) starting 4 weeks prior to study drug initiation and agreement to use such a method during study participation and for an additional 12 weeks after the end of study drug administration
7. Participation in NIH protocol 94-I-0079 (Activation and function of eosinophils in conditions with blood or tissue eosinophilia)
8. Ability of subject to understand and the willingness to sign a written informed consent document

1. Pregnancy or lactation
2. Known allergic reaction to dupilumab or any of the excipients in Dupixent(TM)
3. Febrile illness within 7 days of enrollment
4. Treatment with an investigational drug or other intervention other than mepolizumab, reslizumab, or benralizumab within 3 months or 4 half-lives of the investigational agent (whichever is longer).
5. Known or suspected acquired or inborn immunodeficiency disorder, including HIV infection
6. Known diagnosis of eosinophilic granulomatosis with polyangiitis
7. Change in eosinophil-active therapy within the past 6 weeks, including but not limited to topical corticosteroids, leukotriene inhibitors, initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food (in patients with gastrointestinal involvement), and proton pump inhibitors (in patients with gastrointestinal involvement)
8. Planned or anticipated major surgical procedure during the study
9. Active parasitic infection
10. History of malignancy within 5 years, excluding completely treated in situ carcinoma of the cervix, or squamous or basal cell carcinoma of the skin
11. Any condition that, in the investigator s opinion, places the patient at undue risk by participating in the study
1. Active infection with Helicobacter pylori
2. History of achalasia, Crohn s disease, ulcerative colitis, celiac disease, or prior esophageal surgery
3. Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to 10 mm upper endoscope

Contacts and Locations

Study Contact

Ejiofor AD Ezekwe, M.D.

CONTACT

(240) 539-8378

ejiofor.ezekwe@nih.gov

Amy D Klion, M.D.

CONTACT

(301) 435-8903

aklion@niaid.nih.gov

Principal Investigator

Amy D Klion, M.D.

PRINCIPAL_INVESTIGATOR

National Institute of Allergy and Infectious Diseases (NIAID)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Amy D Klion, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-01

Study Completion Date2027-03-30

Study Record Updates

Study Start Date2025-01-01

Study Completion Date2027-03-30

Terms related to this study

Keywords Provided by Researchers

Hypereosinophilic Syndrome
Eosinophil
Monoclonal Antibody
Clinical Trial
Treatment

Additional Relevant MeSH Terms

Hypereosinophilic Syndrome