Effect of Dupilumab on the Muscle Function of the Esophagus (food Pipe) in Participants with Eosinophilic Esophagitis (EoE)

NCT06665971 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 810335
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eosinophilic Esophagitis (EoE)

Keywords

Dupilumab; Dupixent; EoE; Eosinophilic esophagitis; Esophagitis; inflammation; Esophagus; Dysphagia; Difficulty swallowing; food stuck in throat; Motility; Gastroenterology

Outcome Measures

Primary Outcomes (1)

• To determine the change in the peak esophageal muscle thickness during peristalsis following 12 weeks of Dupilumab

  To see if there is an improvement in the longitudinal muscle dysfunction - increase in the muscle thickness (difference between baseline and at the peak of swallow-induced esophageal contraction), and peak muscle thickness at the peak of circular muscle contraction, measured in millimeters will be recorded. The investigators will make paired observation in each participant, i.e., before and after treatment with Dupilumab, and perform paired t test statistics.

  From baseline assesment at 2 weeks to the end of the study at 14 weeks

Secondary Outcomes (3)

• To determine the change in the esophageal luminal cross-sectional area ( measured in mm2) following treatment with Dupilumab

  From baseline assesment at 2 weeks to the end of treatment at 14 weeks

• To determine the differences in amplitude of longitudinal muscle contraction in EOE participants who have reduction in eosinophil count < 6 HPF, compared to the one with eosinophil count > 6HPF following 12 weeks treatment with Dupilumab

  From week 2 till the end of the study at 12 weeks

• To determine the differences in the luminal CSA during peristalsis following 12 weeks of treatment with Dupilumab in EOE participants who have reduction in the eosinophil count of < 6 HPF as compared to the one with eosinophil count of > 6HPF.

  From baseline assesment at week 2 to the study end date at 12 weeks.

Study Arms (1)

EoE participants treated with Dupilumab

EXPERIMENTAL

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.

Drug: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

Interventions

Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] DRUG

Dosage form: Subcutaneous injection Dosage: 300 mg/ 2ml Dosage frequency: Once a week Duration: 12 weeks

EoE participants treated with Dupilumab

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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. 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

University of California San Diego (UCSD) Health Medical center

La Jolla, California, 92037, United States

RECRUITING

Related Publications (30)

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MeSH Terms

Conditions

Eosinophilic Esophagitis; Esophagitis; Inflammation; Deglutition Disorders

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Anant Gupta, MBBS

CONTACT

314-685-9214; ucsdgimotility@gmail.com

Ravinder Mittal, MD

CONTACT

858-534-3328; rmittal@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study is a single arm clinical trial with subgroup analysis comparing responder's vs non-responders. Methods used to minimize bias: All participants will be treated with medications. There is no placebo arm of the study. Based on the available data the response to the drug is approximately 60%, i.e., eosinophil count of \< 6/HPF on esophageal mucosal biopsy (Responders). The remaining 40% participants are expected to have eosinophil count of \> 6/HPF on esophageal mucosal biopsy after treatments (Non-responders). The study design is to compare the responder vs non-responders.

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 30, 2024
• Study Start: November 10, 2024
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): November 14, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-10

Locations

US (1)