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New treatment option for Eosinophilic Esophagitis (EoE)
Official title Effect of Dupilumab on the Muscle Function of the Esophagus (food Pipe) in Participants with Eosinophilic Esophagitis (EoE)
ClinicalTrials.gov ID: NCT06665971
What this study is testing
What is Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]?
Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for eosinophilic esophagitis (eoe).
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
- The goal of this study is to research Dupilumab, an FDA approved medication in treating patients diagnosed with Eosinophilic esophagitis (EoE). The drug works by controlling allergic inflammation of the esophagus.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study including regular follow-up with the study...
- Persons aged 22-75 years of age, males and females, of all ethnic races.
- Participants must be diagnosed with PPI resistant eosinophilic esophagitis (EoE) (proven by endoscopic biopsy showing \> 15 eosinophils/HPF prior to...
You likely can't join if
- Participants will be excluded from the study if they have any of the followings:
- Prior participation in a Dupilumab clinical trial, or past or current treatment with Dupilumab
- Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to screening...
- Other causes of esophageal eosinophilia for the following conditions: hyper eosinophilic syndrome and eosinophilic granulomatosis with polyangiitis...
- Active Helicobacter pylori infection, history of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery
- Participant with significant other medical condition that would prevent treatment with Dupilumab and close follow up of their EOE condition.
See the full eligibility criteria
Who can join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study including regular follow-up with the study monitor.
- Persons aged 22-75 years of age, males and females, of all ethnic races.
- Participants must be diagnosed with PPI resistant eosinophilic esophagitis (EoE) (proven by endoscopic biopsy showing \> 15 eosinophils/HPF prior to and 8 weeks after treatment with PPI) will be eligible to participate...
- Ability to take subcutaneous medication and willing to adhere to the 12-week Dupilumab regimen.
- Eligible participants must not have taken inhalational, oral or IV steroids for at least 8 weeks prior to the study.
What rules you out
- Participants will be excluded from the study if they have any of the followings:
- Prior participation in a Dupilumab clinical trial, or past or current treatment with Dupilumab
- Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to screening. Participants on a food-elimination diet must remain on the same diet...
- Other causes of esophageal eosinophilia for the following conditions: hyper eosinophilic syndrome and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome), Participants with eosinophilic...
- Active Helicobacter pylori infection, history of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery
- Participant with significant other medical condition that would prevent treatment with Dupilumab and close follow up of their EOE condition.
- Initiation, discontinuation, or change in the dosage regimen of the following medications within 8 weeks prior to the baseline endoscopy:
- Proton pump inhibitors (except for participants who require a PPI trial prior to baseline endoscopy)
- Leukotriene inhibitors
- Nasal and/or inhaled corticosteroids
- Participants on a stable dose of these medications for at least 8 weeks prior to the baseline endoscopy may be included in the study but must not change the dose during the study.
- Participants who have asthma and use an asthma medicine c) have atopic dermatitis, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, or prurigo nodularis and also have asthma, then do not change or...
- Initiation, discontinuation, or change in the dosage regimen of SC immunotherapy (SCIT), participants on a stable dose of these medications for at least 1 year prior to visit 1 may be included in the study but must not...
- Treatment with sublingual immunotherapy (SLIT)
- Treatment with oral immunotherapy (OIT) within 6 months prior to visit 1.
- The following treatments within 3 months prior to screening, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the study:
- Systemic immunosuppressant/immunomodulating drugs, including but not limited to systemic corticosteroids, omalizumab, cyclosporine, mycophenolate-mofetil, interferon-gamma [IFN-γ], Janus kinase inhibitors, azathioprine...
- Treatment with an investigational drug within 2 months or within 5 half-lives (if known), whichever is longer, prior to visit.
- Planned or anticipated use of any prohibited medications and procedures during the study
- Planned or anticipated major surgical procedure during the study.
- Treatment with a live (attenuated) vaccine within 4 weeks prior to the baseline visit
- Active parasitic infection or suspected parasitic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before randomization.
- Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before baseline visit. Note: A participant may be re-screened after the infection resolves.
- Known or suspected immunodeficiency disorder, including history of invasive opportunistic infections (e.g., tuberculosis [TB], non-tuberculous mycobacterial infections, histoplasmosis, listeriosis, coccidioidomycosis...
- Tuberculosis testing will be performed if required by regulatory authorities or ethics committees (ECs).
- Known history of human immunodeficiency virus (HIV) infection
- Established diagnosis of hepatitis B viral infection at the time of screening or positive for hepatitis B surface antigen (HBsAg) at the time of screening. Participants who have gained immunity for hepatitis B virus...
- Established diagnosis of hepatitis C viral (HCV) infection at the time of screening. Participants positive for hepatitis C Ab are eligible for the study only if HCV RNA is negative.
- On current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis, or hepatic failure, or has evidence of liver disease as indicated by persistent (confirmed by repeated tests...
- Any of the following abnormal lab values at screening:
- Platelets \<100 ×103/μL
- Neutrophils \<1.5 × 103/μL
- Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 If an abnormal value is detected at screening, a repeat test should be performed to confirm the abnormality. Only if the repeat test confirms the...
- If the participant: are taking oral, topical, or inhaled corticosteroid medicines, have asthma and use an asthma medicine, have atopic dermatitis, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis...
- Do not change or stop corticosteroid medicine or other asthma medicine without talking to the investigators. This may cause other symptoms that were controlled by the corticosteroid medicine or other asthma medicine to...
- Severe concomitant illness (es) that, in the investigator's judgment, would adversely affect the participant's participation in the study. Examples include but are not limited to short life expectancy, uncontrolled...
- History of malignancy within 5 years prior to screening, except completely treated in situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin.
- History of alcohol or drug abuse within 6 months prior to screening
- Any other medical or psychological condition including relevant laboratory abnormalities at screening that, in the opinion of the investigator, suggest a new and/or insufficiently understood disease, may present an...
- Participant or his/her immediate family is a member of the investigational team
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
- Heterosexual women of childbearing potential who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 12 weeks after the...
- Stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition...
- Intrauterine device; intrauterine hormone-releasing system
- Bilateral tubal ligation
- Vasectomized partner
- And/or sexual abstinence.
- Postmenopausal women must have amenorrhea for at least 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or...
- Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual...
- Known systemic hypersensitivity to Dupilumab or the excipients of the drug product. This includes hypersensitivity reactions such as anaphylaxis, serum sickness, angioedema, urticaria, rash, erythema nodosum, and...
- If participant have or develop significant dysphagia, dilation of the esophagus using endoscopic, Savary or other kind of dilators will be allowed during the treatment with Dupilumab.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, 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, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, 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.