๐ฌIn plain words
What the trial is, and whether it could suit you
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. The esophagus is a food pipe that transfers food from the mouth into the stomach. Participants with EoE have dysfunction of the muscle of the esophagus (impaired peristalsis) that is not favorable for the transport function.
Main question this study aims to answer is: Whether Dupilumab helps improve muscle activity of the esophagus in participants with EOE?
Participants will:
Take Dupilumab every week for 12 weeks. Visit the clinic before and after starting the medication. Keep a diary of symptoms.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
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 in the study.
* 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.
Exclusion Criteria:
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 throughout the study.
* Other causes of esophageal eosinophilia for the following conditions: hyper eosinophilic syndrome and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome), Participants with eosinophilic gastroenteritis are eligible, provided they meet other eligibility criteria.
* 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 stop their 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 come back.
* 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 change the dose during the study.
* 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 \[IFN-ฮณ\], Janus kinase inhibitors, azathioprine, and methotrexate: One-time use of a corticosteroid as a part of the anesthetic preparation used during each endoscopy procedure is allowed.
* 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, pneumocystis, aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency, or prolonged infections suggesting an immune-compromised status, as judged by the investigator.
* 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 infection after vaccination (participants who are HBsAg negative, hepatitis B surface antibody \[HBsAb\] positive, and hepatitis B core antibody \[HBcAb\] negative are eligible for the study). Participants with positive HBcAb are eligible for the study only if hepatitis B virus DNA level is undetectable.
* 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 (c