Dupilumab for Eosinophilic Esophagitis (DESTRICT Trial)
Palo Alto (17 mi)Age: Any Age
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of North Carolina, Chapel Hill
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this research study is to determine how well an FDA-approved drug, dupilumab, works to treat patients with severe strictures and active Eosinophilic Esophagitis (EoE). This is an open-label study, meaning everyone in the study will receive dupilumab.
Participants will have a screening visit where they will complete surveys and undergo an endoscopy (EGD). Blood and biopsies (small tissue samples) will also be collected. If eligible and enrolled into the study, participants will receive weekly subcutaneous (under the skin) injections of dupilumab for 52 weeks (one year). The first dose of dupilumab will be administered at the week 1 visit by a clinician and participants will receive training on how to self-administer the remaining doses.
Participants will return for study visits every at weeks 4, 8, 12, 18, 24, 30, 36, 44, and 52. During these visits, vital signs (temperature, heart rate, etc.) will be collected and participants will complete surveys. During visits at week 12, 24, and 52, blood will be collected and an endoscopy with biopsy will be performed.
At 64 weeks (12 weeks after the last dose of dupilumab), participants assigned male at birth (AMAB) will be contacted about their / their partner's pregnancy status and participants assigned female at birth (AFAB) may be asked to come for an in-person visit to complete a urine pregnancy test.
Is the drug Dupilumab a promising treatment for eosinophilic esophagitis?Yes, Dupilumab is a promising treatment for eosinophilic esophagitis. It is the first drug approved specifically for this condition, showing effectiveness in reducing inflammation and improving symptoms in both clinical trials and real-world settings.24578
What safety data is available for Dupilumab in treating eosinophilic esophagitis?The LIBERTY EoE TREET study assessed the long-term safety of Dupilumab in adults and adolescents with eosinophilic esophagitis. Additionally, a safety update from the Medicines and Healthcare products Regulatory Agency highlights the risk of ocular adverse reactions associated with Dupilumab, emphasizing the need for prompt management.35678
What data supports the idea that Dupilumab for Eosinophilic Esophagitis is an effective drug?The available research shows that Dupilumab is effective in treating Eosinophilic Esophagitis. In the LIBERTY EoE TREET study, Dupilumab was tested over 52 weeks and showed positive results in reducing inflammation in patients. Another study highlighted its real-world effectiveness in patients with severe forms of the condition who did not respond to other treatments. Additionally, Dupilumab is the first drug approved specifically for this disease, indicating its effectiveness compared to other treatments that are not specifically approved for Eosinophilic Esophagitis.13578
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you must stop all current medications. However, you cannot change your PPI dose, use topical or systemic steroids for EoE, or take certain biologic medications. If you're on blood thinners, you may need to stop them briefly before an endoscopy.
Eligibility Criteria
This trial is for individuals with severe narrowing of the esophagus (strictures) due to Eosinophilic Esophagitis (EoE), a chronic allergic/immune condition. Participants must have active symptoms and will be screened with an endoscopy. The study requires weekly self-administered injections for one year, regular check-ups, blood tests, and additional endoscopies.Treatment Details
The trial is testing Dupilumab, an FDA-approved drug, to see how effective it is in treating severe strictures caused by EoE. All participants will receive the drug through under-the-skin injections once a week for 52 weeks and their health progress will be monitored regularly.
1Treatment groups
Experimental Treatment
Group I: Open Label dupilumabExperimental Treatment1 Intervention
Open label dupilumab 300mg injection given subcutaneously weekly, for 52 weeks.
Dupilumab is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Dupixent for:
- Atopic dermatitis
- Asthma
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
🇪🇺 Approved in European Union as Dupixent for:
- Atopic dermatitis
- Asthma
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of North Carolina at Chapel HillChapel Hill, NC
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Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
Regeneron PharmaceuticalsIndustry Sponsor
SanofiIndustry Sponsor
References
Efficacy of Dupilumab in a Phase 2 Randomized Trial of Adults With Active Eosinophilic Esophagitis. [2021]Eosinophilic esophagitis (EoE) is an allergen-mediated inflammatory disease with no approved treatment in the United States. Dupilumab, a VelocImmune-derived human monoclonal antibody against the interleukin (IL) 4 receptor, inhibits IL4 and IL13 signaling. Dupilumab is effective in the treatment of allergic, atopic, and type 2 diseases, so we assessed its efficacy and safety in patients with EoE.
Improvement in eosinophilic esophagitis when using dupilumab for other indications or compassionate use. [2022]Dupilumab has been approved to treat atopic dermatitis, asthma, and nasal polyps and is in active clinical trials for the treatment of eosinophilic esophagitis (EoE). Given its shared immunopathology, we hypothesized that EoE symptoms and inflammation would improve when dupilumab therapy was used for other allergic indications.
A Case Series on the Use of Dupilumab for Treatment of Refractory Eosinophilic Gastrointestinal Disorders. [2023]The incidence and prevalence of eosinophilic esophagitis (EoE), eosinophilic gastritis (EoG), eosinophilic enteritis (EoN), and eosinophilic colitis (EoC) are increasing ( 1 ). These conditions will inevitably become more widely recognized and better understood. There is currently no Food and Drug Administration (FDA)-approved treatment for EoE, but there are standard-of-care treatments that are well established and widely used. In contrast, there is a paucity of data regarding standard-of-care treatment for non-EoE eosinophilic gastrointestinal disorders (EGID). We identified 3 patients that all achieved clinical and histopathologic remission on dupilumab, a monoclonal antibody that blocks the downstream signaling of interleukin (IL)-4 and IL-13. These patients had extra-esophageal forms of EGID with two patients failing to achieve remission on standard-of-care therapies and one patient experiencing significant side effects on swallowed budesonide therapy. The reduction in mucosal eosinophilia in several GI tract segments in these 3 patients highlights a new potential clinical indication for dupilumab in the treatment of pediatric EGID patients.
Dupilumab-induced hypereosinophilia: review of the literature and algorithm proposal for clinical management. [2022]Dupilumab is a human monoclonal antibody that targets both IL-4 and IL-13 signaling. It is currently indicated for the treatment of asthma, moderate-to-severe atopic dermatitis, and chronic rhinosinusitis with nasal polyps (CRSwNP). Eosinophilia has been reported as a potential adverse event in treated patients.
New Indication for Dupilumab. [2022]Dupilumab (Dupixent) has been approved to treat eosinophilic esophagitis in adults and children ages 12 years and older who weigh at least 40 kilograms. This is the first drug approved to treat this disease.
Safety update: dupilumab and ocular adverse reactions. [2022]Overview of: Medicines and Healthcare products Regulatory Agency. Dupilumab (Dupixent▼): risk of ocular adverse reactions and need for prompt management. Drug Safety Update 2022;16(4): 1.
Efficacy and safety of dupilumab up to 52 weeks in adults and adolescents with eosinophilic oesophagitis (LIBERTY EoE TREET study): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. [2023]Long-term management options that specifically target the underlying inflammation in eosinophilic oesophagitis are needed. Dupilumab blocks the shared receptor component for interleukin (IL)-4/IL-13; we aimed to assess its long-term efficacy and safety in adults and adolescents with eosinophilic oesophagitis enrolled in part B of the LIBERTY EoE TREET study who continued to part C (part B-C).
Real-World Efficacy of Dupilumab in Severe, Treatment-Refractory, and Fibrostenotic Patients With Eosinophilic Esophagitis. [2023]Dupilumab is approved for treatment of eosinophilic esophagitis (EoE), but real-world data are lacking. We aimed to determine the real-world efficacy of dupilumab in patients with severe, treatment-refractory, and fibrostenotic EoE.