BridgeMD
New treatment option for Hypereosinophilic Syndrome
Official title Dupilumab as Add-On Therapy for Hypereosinophilic Syndrome With Partial Clinical Response to Eosinophil-Depleting Biologic Agents
ClinicalTrials.gov ID: NCT06477653
What this study is testing
What is dupilumab?
dupilumab is an investigational medicine, given as an once-daily, being studied as a potential treatment for hypereosinophilic syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- To be eligible to participate in this study, an individual must meet all the following criteria:
- 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...
- Currently receiving treatment with an eosinophil-lowering biologic (mepolizumab, reslizumab, or benralizumab) for a minimum of 24 weeks
- AEC\<0.5x10\^9/L
You likely can't join if
- 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...
- Known or suspected acquired or inborn immunodeficiency disorder, including HIV infection
See the full eligibility criteria
- To be eligible to participate in this study, an individual must meet all the following criteria:
- 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 (histologic evidence of...
- Currently receiving treatment with an eosinophil-lowering biologic (mepolizumab, reslizumab, or benralizumab) for a minimum of 24 weeks
- AEC\<0.5x10\^9/L
- 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...
- 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...
- Participation in NIH protocol 94-I-0079 (Activation and function of eosinophils in conditions with blood or tissue eosinophilia)
- Ability of subject to understand and the willingness to sign a written informed consent document
- 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
- 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...
- Planned or anticipated major surgical procedure during the study
- Active parasitic infection
- History of malignancy within 5 years, excluding completely treated in situ carcinoma of the cervix, or squamous or basal cell carcinoma of the skin
- Any condition that, in the investigator s opinion, places the patient at undue risk by participating in the study For patients with eosinophilic gastrointestinal disease only:
- Active infection with Helicobacter pylori
- History of achalasia, Crohn s disease, ulcerative colitis, celiac disease, or prior esophageal surgery
- Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to 10 mm upper endoscope
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.