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Monoclonal Antibodies

Dupilumab for Eosinophilic Esophagitis

Phase 4

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History (by participant report) of an average of at least 2 episodes of dysphagia (with intake of solids) per week in the 4 weeks prior to screening

Body weight ≥40 kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at weeks 24, 76 and 128

Awards & highlights

Study Summary

This trial will last for 2.5 years and will study the effects of a drug called dupilumab on esophageal function in adults with eosinophilic esophagitis.

Who is the study for?

Adults with a confirmed diagnosis of Eosinophilic Esophagitis (EoE) who experience at least two episodes of difficulty swallowing solid food per week and weigh over 40 kg can join. Those without proper biopsy confirmation or outside the weight criteria cannot participate.Check my eligibility

What is being tested?

The study is testing Dupilumab against a placebo to see its effects on esophageal function in EoE patients. Initially, participants are randomly assigned to receive either Dupilumab or placebo for six months, followed by everyone receiving Dupilumab for an additional two years.See study design

What are the potential side effects?

Dupilumab may cause side effects such as allergic reactions at the injection site, cold sores in your mouth or throat, and eye problems like redness, itching, or swelling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had trouble swallowing solids at least twice a week in the last month.

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I weigh at least 40 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at weeks 24, 76 and 128

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at weeks 24, 76 and 128

This trial's timeline: 3 weeks for screening, Varies for treatment, and at weeks 24, 76 and 128 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe (EndoFLIP)

Secondary outcome measures

Absolute change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe

Change from baseline in EoE-HSS Stage

Change from baseline in eosinophilic esophagitis (EoE-HSS) Grade

+8 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367

12%

Accidental Overdose

Conjunctivitis

Nasopharyngitis

Headache

Dermatitis Atopic

Fall

Multiple Fractures

100%

80%

60%

40%

20%

Study treatment Arm

DB Period: Placebo

OLE Period: Dupilumab/Dupilumab

OLE Period: Placebo/Dupilumab

DB Period: Dupilumab

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DupilumabExperimental Treatment1 Intervention

Subcutaneous injection (SC) as per protocol

Group II: PlaceboPlacebo Group1 Intervention

SC injection as per protocol

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dupilumab

2017

Completed Phase 4

~12230

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,916 Total Patients Enrolled

5 Trials studying Eosinophilic Esophagitis

779 Patients Enrolled for Eosinophilic Esophagitis

Regeneron PharmaceuticalsIndustry Sponsor

621 Previous Clinical Trials

380,541 Total Patients Enrolled

7 Trials studying Eosinophilic Esophagitis

850 Patients Enrolled for Eosinophilic Esophagitis

Clinical Sciences & OperationsStudy DirectorSanofi

862 Previous Clinical Trials

2,019,774 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants being enrolled in this research project?

"Yes, as per clinicaltrials.gov data, this medical research study is presently enrolling participants. The trial was initially disclosed on November 29th, 2023 and the most recent update was made on February 16th, 2024. This investigation aims to recruit a total of 64 individuals from five different sites."

Answered by AI

What is the level of safety associated with Dupilumab for individuals?

"Dupilumab's safety is rated as 3 by our team at Power due to its Phase 4 trial status, indicating that this treatment has already received approval."

Answered by AI

Are there numerous medical centers conducting this research in the United States?

"At this moment, patient recruitment is ongoing at 5 distinct locations including Murrieta, Gurnee, and Jacksonville. It's advisable to choose a site in close proximity to your residence for convenience during the trial period."

Answered by AI

Are there any available vacancies for patient participation in this clinical trial?

"Affirmative. The details available on clinicaltrials.gov indicate that patient enrollment is ongoing for this medical research study. It was initially posted on November 29, 2023, and last revised on February 16, 2024. A total of 64 participants are sought across five designated locations for inclusion in the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Assessing Esophageal Function and Remodeling With Dupilumab Compared With Placebo for 24 Weeks Followed by 104 Weeks Open Label in Adult Participants With EoE (REMOdeling With Dupilumab in Eosinophilic Esophagitis Long-term Trial)

2023. "A Study Assessing Esophageal Function and Remodeling With Dupilumab Compared With Placebo for 24 Weeks Followed by 104 Weeks Open Label in Adult Participants With EoE (REMOdeling With Dupilumab in Eosinophilic Esophagitis Long-term Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06101095.

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