Dupilumab for Eosinophilic Esophagitis

Overseen By Ravinder Mittal, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

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 All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether Dupilumab, a medication approved by the FDA, can improve the muscle activity of the esophagus in people with eosinophilic esophagitis (EoE). EoE is a condition where the esophagus becomes inflamed due to allergies, making swallowing difficult. Participants will receive a weekly injection of Dupilumab for 12 weeks and will monitor their symptoms. The trial seeks participants diagnosed with EoE that does not improve with standard treatments like proton pump inhibitors and who have not recently taken certain medications, such as steroids. As a Phase 4 trial, this research aims to understand how Dupilumab, already FDA-approved and proven effective, can benefit more patients with EoE.

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 is the safety track record for Dupilumab?

Research has shown that Dupilumab is generally safe for people with eosinophilic esophagitis (EoE). Studies have found that most patients tolerate this treatment well. Some mild side effects, such as injection site reactions and allergic reactions, have been reported, but these are usually manageable. Importantly, the FDA has approved Dupilumab for treating EoE in both adults and children, adding confidence in its safety for this condition. This approval indicates thorough safety evaluation. Overall, Dupilumab has a strong safety record for people with EoE. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Dupilumab is unique because it targets the underlying cause of Eosinophilic Esophagitis (EoE) by blocking the signaling of two key proteins, IL-4 and IL-13, which are involved in inflammation. Unlike traditional treatments that might focus on managing symptoms with steroids or dietary changes, Dupilumab directly addresses the immune response contributing to EoE. Researchers are excited about this treatment because it offers a novel approach with the potential for long-term relief and fewer side effects compared to current therapies.

What is the effectiveness track record for Dupilumab in treating Eosinophilic Esophagitis?

Studies have shown that Dupilumab effectively treats Eosinophilic Esophagitis (EoE). Previous research demonstrated that Dupilumab reduced tissue inflammation in more patients compared to a placebo. It also significantly alleviated symptoms like difficulty swallowing, with noticeable improvements in patient well-being. Moreover, Dupilumab's effects persisted over time, providing ongoing relief from EoE symptoms. This medication controls allergic inflammation in the esophagus, improving its function. Overall, Dupilumab is a proven treatment for EoE, offering relief from its challenging symptoms. In this trial, all participants will receive Dupilumab through a once-a-week subcutaneous injection for 12 weeks. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab

Trial Overview 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Published Research Related to This Trial

Dupilumab, a monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling, showed promising results in achieving clinical and histopathologic remission in three pediatric patients with non-eosinophilic esophagitis gastrointestinal disorders (EGID) who did not respond to standard treatments.

This study suggests that dupilumab may be a potential new treatment option for pediatric patients with eosinophilic gastrointestinal disorders, as it effectively reduced mucosal eosinophilia in multiple segments of the gastrointestinal tract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case Series on the Use of Dupilumab for Treatment of Refractory Eosinophilic Gastrointestinal Disorders. Patel, N., Goyal, A., Thaker, A., et al.[2023]

Dupilumab (Dupixent) is the first medication approved for the treatment of eosinophilic esophagitis, marking a significant advancement in managing this condition.

It is approved for use in both adults and children aged 12 years and older who weigh at least 40 kilograms, highlighting its safety and efficacy for a specific patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Indication for Dupilumab. Aschenbrenner, DS.[2022]

Dupilumab, a monoclonal antibody used to treat conditions like asthma and atopic dermatitis, can cause hypereosinophilia (high eosinophil levels) as a potential adverse effect, which poses a challenge for clinicians.

An algorithm has been proposed to help manage dupilumab-induced hypereosinophilia, allowing for proper investigation of related health issues while minimizing unnecessary discontinuation of the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab-induced hypereosinophilia: review of the literature and algorithm proposal for clinical management. Caminati, M., Olivieri, B., Dama, A., et al.[2022]

In a study involving 240 patients with eosinophilic oesophagitis, dupilumab treatment maintained significant improvements in eosinophil counts and symptoms over 52 weeks, demonstrating its long-term efficacy.

Weekly administration of dupilumab was more effective than biweekly dosing, with 85% of patients on weekly dupilumab achieving a peak eosinophil count of 6 eos/hpf or less, highlighting the importance of dosing frequency in treatment outcomes.

NCBI (Pubmed)

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. Rothenberg, ME., Dellon, ES., Collins, MH., et al.[2023]

In a phase 2 trial involving 47 adults with eosinophilic esophagitis (EoE), dupilumab significantly reduced dysphagia symptoms and histological markers of the disease compared to placebo, indicating its efficacy in treating EoE.

Dupilumab also improved esophageal distensibility by 18% and was generally well tolerated, although some patients experienced injection-site reactions and nasopharyngitis more frequently than those receiving placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Dupilumab in a Phase 2 Randomized Trial of Adults With Active Eosinophilic Esophagitis. Hirano, I., Dellon, ES., Hamilton, JD., et al.[2021]

In a study of 46 patients with severe, treatment-refractory fibrostenotic eosinophilic esophagitis (EoE), dupilumab treatment led to significant improvements in endoscopic, histologic, and symptomatic outcomes after a median of 6 months.

The treatment resulted in an 80% histologic response rate, with a marked decrease in eosinophil counts and a significant increase in esophageal diameter, indicating effective management of this challenging condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Efficacy of Dupilumab in Severe, Treatment-Refractory, and Fibrostenotic Patients With Eosinophilic Esophagitis. Lee, CJ., Dellon, ES.[2023]

In a study of 45 patients with eosinophilic esophagitis (EoE) who were treated with dupilumab for other allergic conditions, 22 out of 26 showed a significant reduction in eosinophil counts in their esophagus after treatment, indicating effective histologic improvement.

The majority of patients (28 out of 45) reported symptom improvement, with 24 achieving complete resolution, and many were able to reduce their EoE medications or expand their diets, demonstrating dupilumab's efficacy in managing EoE symptoms when used for other atopic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in eosinophilic esophagitis when using dupilumab for other indications or compassionate use. Spergel, BL., Ruffner, MA., Godwin, BC., et al.[2022]

Dupilumab (Dupixent) has been associated with a risk of ocular adverse reactions, highlighting the importance of monitoring patients for eye-related side effects during treatment.

Prompt management of any ocular issues is essential for patients receiving dupilumab, ensuring their safety and well-being while benefiting from the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety update: dupilumab and ocular adverse reactions. [2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03633617

NCT03633617 | Study to Determine the Efficacy and Safety ... A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38924731/

Dupilumab for Eosinophilic Esophagitis in Patients 1 to 11 ... Dupilumab resulted in histologic remission in a significantly higher percentage of children with eosinophilic esophagitis than placebo.

3. news.sanofi.us news.sanofi.us/2023-10-22-Dupixent-R-dupilumab-Phase-3-Results-show-sustained-efficacy-for-up-to-one-year-in-children-1-to-11-years-of-age-with-eosinophilic-esophagitis-EoE

Dupixent® (dupilumab) Phase 3 Results show sustained ... Data from this Phase 3 trial support the potential of dupilumab to treat EoE in children, with sustained efficacy and safety, which is ...

4. dupixenthcp.com dupixenthcp.com/eoe/efficacy-safety/efficacy

Efficacy in EoE | DUPIXENT® (dupilumab) DUPIXENT was studied across clinical, histologic, and endoscopic endpoints up to 52 weeks · DUPIXENT REDUCED THE FREQUENCY AND SEVERITY OF DYSPHAGIA SYMPTOMS ...

5. gi.org gi.org/journals-publications/ebgi/eluri_dec2024/

Long Term Efficacy and Safety of Dupilumab for ... Weekly dupilumab significantly reduced dysphagia symptoms, with a mean DSQ score improvement of –30.3 points, and decreased peak eosinophil ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06693531?term=NCT06693531&rank=1

A U.S. Registry of Eosinophilic Esophagitis Adolescent and ... The purpose of this research study is to look at how DUPIXENT is used in normal care of patients with EoE. Possible benefits to others include a ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02379052

NCT02379052 | Study of Dupilumab in Adult Participants ... To assess the safety, tolerability, and immunogenicity of SC doses of dupilumab in adult participants with active, moderate to severe EoE; To assess the effect ...

8. io.nihr.ac.uk io.nihr.ac.uk/wp-content/uploads/2023/07/29964-Dupilumab-for-Eosinophilic-Oesophagitis-V1.0-MAY2023-NON-CONF.pdf

Health Technology Briefing May 2023 Press Release: Dupixent® (dupilumab) Phase 3 trial shows positive results in children. 1 to 11 years of age with eosinophilic esophagitis.

9. dupixenthcp.com dupixenthcp.com/eoe/efficacy-safety

DUPIXENT® (dupilumab) Efficacy & Safety for EoE Explore efficacy & safety results for DUPIXENT® (dupilumab) in clinical trials for eosinophilic esophagitis (EoE) adult & pediatric patients aged 1+ years, ...