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Monoclonal Antibodies
Dupilumab for Eosinophilic Esophagitis
Phase 4
Waitlist Available
Led By Jonathan Spergel, MD, PhD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of Eosinophilic Esophagitis based on the most recent international consensus definition
Males or females age 6 to 25 years
Must not have
Therapy with biologic molecule in prior 12 months
Subjects unable to follow the protocol and the protocol requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests if a treatment can help people with EoE reintroduce foods that usually cause their symptoms. The treatment works by reducing inflammation in the body, potentially allowing these patients to eat foods like milk, egg, wheat, and soy without issues.
Who is the study for?
This trial is for children and young adults aged 6 to 25 with Eosinophilic Esophagitis (EoE) triggered by milk, egg, soy, or wheat. Participants must have a history of EoE confirmed by endoscopy within the last two years and weigh over 10 kg. They should be on a stable dose of Proton Pump Inhibitors and not have used biologics or immunotherapy recently. Girls over 11 need a negative pregnancy test.
What is being tested?
The study tests if Dupilumab, an inhibitor targeting type-2 inflammation, can help patients with EoE reintroduce foods that previously caused allergic reactions into their diets without triggering symptoms. It's conducted at one site and involves introducing specific foods while monitoring the effects.
What are the potential side effects?
Potential side effects of Dupilumab may include allergic reactions at the injection site, eye irritation or redness, cold sores in your mouth or throat area, joint pain(s), and inflammation around your heart.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Eosinophilic Esophagitis according to the latest guidelines.
Select...
I am between 6 and 25 years old.
Select...
I have been diagnosed with Eosinophilic Esophagitis based on an endoscopy.
Select...
I can stay on my current dose of acid reflux medication during the study.
Select...
I am a girl over 11 and my pregnancy test is negative.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had biologic therapy in the last year.
Select...
I can follow all study requirements.
Select...
I do not have an active or suspected parasitic infection.
Select...
I have biopsy proof of eosinophilic infiltration in an organ.
Select...
I will not have any major elective surgeries during the study.
Select...
I have had major procedures on my esophagus.
Select...
I have not received a live vaccine within the last 4 weeks.
Select...
I do not have significant inflammatory diseases of the digestive system.
Select...
I am not pregnant, breastfeeding, nor planning to become pregnant or breastfeed during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Esophageal Eosinophilia (number of eosinophils in the esophagus)
Secondary study objectives
Pediatric Eosinophilic Esophagitis Symptom Score (total score based on pediatric symptom score)
Other study objectives
Change in endoscopic Scoring system (EREFS)
Changes in EoE Quality of life from baseline
Rate of Maintenance of Remission (less than <6 eos/hpf) in esophageal biopsy
+1 moreSide effects data
From 2021 Phase 4 trial • 188 Patients • NCT040333679%
Conjunctivitis
7%
Headache
3%
Dermatitis Atopic
2%
Nasopharyngitis
1%
Accidental Overdose
1%
Drug Hypersensitivity
1%
Polyarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Placebo/Dupilumab
OLE Period: Dupilumab/Dupilumab
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Study GroupExperimental Treatment4 Interventions
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~11960
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Eosinophilic Esophagitis (EoE) is primarily treated through dietary management, proton pump inhibitors (PPIs), and biologics like Dupilumab. PPIs reduce acid production, which can help decrease eosinophil activity in the esophagus.
Dupilumab, a biologic, inhibits IL-4 and IL-13 signaling, reducing type 2 inflammation, which is crucial in EoE as it directly targets the inflammatory pathways responsible for eosinophil accumulation and tissue damage. This targeted approach can significantly improve symptoms and quality of life for EoE patients by addressing the underlying inflammatory processes.
Find a Location
Who is running the clinical trial?
Regeneron PharmaceuticalsIndustry Sponsor
658 Previous Clinical Trials
385,608 Total Patients Enrolled
7 Trials studying Eosinophilic Esophagitis
884 Patients Enrolled for Eosinophilic Esophagitis
Genzyme, a Sanofi CompanyIndustry Sponsor
526 Previous Clinical Trials
185,699 Total Patients Enrolled
Children's Hospital of PhiladelphiaLead Sponsor
728 Previous Clinical Trials
8,470,247 Total Patients Enrolled
4 Trials studying Eosinophilic Esophagitis
5,416 Patients Enrolled for Eosinophilic Esophagitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had biologic therapy in the last year.I can follow all study requirements.I have been diagnosed with Eosinophilic Esophagitis according to the latest guidelines.I am between 6 and 25 years old.I have been diagnosed with Eosinophilic Esophagitis based on an endoscopy.I do not have an active or suspected parasitic infection.I have biopsy proof of eosinophilic infiltration in an organ.I will not have any major elective surgeries during the study.I have not taken antibiotics, antivirals, or antifungals for an infection in the last 2 weeks.I have had major procedures on my esophagus.I have not received a live vaccine within the last 4 weeks.I do not have significant inflammatory diseases of the digestive system.I have not used any immunosuppressants in the last 3 months.I have conditions that make anesthesia risky for me.I haven't had immunotherapy for food allergies in the last 3 months.I can stay on my current dose of acid reflux medication during the study.I am a girl over 11 and my pregnancy test is negative.I am not pregnant, breastfeeding, nor planning to become pregnant or breastfeed during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Study Group
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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