Dupilumab for Eosinophilic Esophagitis

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of California, San Diego

Must be taking: Dupilumab

Must not be taking: Systemic corticosteroids, Omalizumab, Methotrexate, others

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you have not taken inhalational, oral, or IV steroids for at least 8 weeks before starting. If you're on a stable dose of certain medications like proton pump inhibitors, leukotriene inhibitors, or corticosteroids, you can continue them but must not change the dose during the study. Always discuss with the investigators before making any changes to your medications.

What data supports the effectiveness of the drug Dupilumab for treating eosinophilic esophagitis?

Research shows that Dupilumab is effective in treating eosinophilic esophagitis by reducing inflammation in the esophagus. It has been approved for use in adults and children over 12 years old, and studies have shown it helps patients who have not responded to other treatments.

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Is Dupilumab safe for humans?

Dupilumab has been studied for its safety in treating eosinophilic esophagitis and other conditions. While it is generally considered safe, there is a known risk of eye-related side effects, which require prompt management.

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What makes the drug Dupilumab unique for treating eosinophilic esophagitis?

Dupilumab is unique because it is the first drug approved specifically to treat eosinophilic esophagitis, targeting the underlying inflammation by blocking the receptor for interleukin (IL)-4 and IL-13, which are involved in the disease's immune response.

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Eligibility Criteria

This trial is for patients with Eosinophilic Esophagitis (EoE), a condition where the esophagus becomes inflamed due to allergies. Participants should have muscle dysfunction in their esophagus, affecting food movement. The study excludes details on specific inclusion and exclusion criteria.

Inclusion Criteria

I can take medication under the skin and will follow a 12-week treatment plan.

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

Exclusion Criteria

Abnormal lab values at screening

I haven't had cancer in the last 5 years, except for treated skin or cervical cancer.

I am currently being treated for liver disease.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive Dupilumab once a week for 12 weeks to assess its effect on esophageal peristaltic function

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

Participant Groups

The study tests Dupilumab, an FDA-approved drug for allergic inflammation, to see if it improves the muscle function of the esophagus in EoE patients. Participants will take Dupilumab weekly for 12 weeks and monitor symptoms in a diary.

Group I: EoE participants treated with Dupilumab Experimental Treatment 1 Intervention

All the participants will be treated with once a week subcutaneous injection of Dupilumab 300 mg through for 12 weeks. There is no placebo arm in the study.

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 Nearby Select from list below to view details:

University of California San Diego (UCSD) Health Medical center La Jolla, CA

Who Is Running the Clinical Trial?

University of California, San Diego Lead Sponsor

Regeneron Pharmaceuticals Industry Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

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.

2. United States pubmed.ncbi.nlm.nih.gov

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.

3. United States pubmed.ncbi.nlm.nih.gov

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.

4. United States pubmed.ncbi.nlm.nih.gov

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.

5. Netherlands pubmed.ncbi.nlm.nih.gov

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).

6. England pubmed.ncbi.nlm.nih.gov

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.

7. England pubmed.ncbi.nlm.nih.gov

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.

8. United States pubmed.ncbi.nlm.nih.gov

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.