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Monoclonal Antibodies
Dupilumab for Eosinophilic Esophagitis
Phase 4
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights
Study Summary
This trial is testing whether dupilumab can help people with Eosinophilic Esophagitis (EoE) eat foods they're allergic to without experiencing symptoms.
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.Check my eligibility
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.See study design
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.
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I am between 6 and 25 years old.
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I have been diagnosed with Eosinophilic Esophagitis based on an endoscopy.
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I can stay on my current dose of acid reflux medication during the study.
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I am a girl over 11 and my pregnancy test is negative.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Esophageal Eosinophilia (number of eosinophils in the esophagus)
Secondary outcome measures
Pediatric Eosinophilic Esophagitis Symptom Score (total score based on pediatric symptom score)
Other outcome measures
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
OLE Period: Placebo/Dupilumab
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Dupilumab/Dupilumab
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
~12230
Find a Location
Who is running the clinical trial?
Regeneron PharmaceuticalsIndustry Sponsor
617 Previous Clinical Trials
380,175 Total Patients Enrolled
7 Trials studying Eosinophilic Esophagitis
884 Patients Enrolled for Eosinophilic Esophagitis
Genzyme, a Sanofi CompanyIndustry Sponsor
524 Previous Clinical Trials
85,600 Total Patients Enrolled
Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,581,245 Total Patients Enrolled
3 Trials studying Eosinophilic Esophagitis
5,341 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Dupilumab acquired clearance from the FDA?
"The safety profile of dupilumab is rated as a 3 on our scale, reflecting the fact that this treatment has been approved by regulatory bodies."
Answered by AI
Are recruitment efforts still open for this investigation?
"Affirmative. According to the clinicaltrials.gov repository, recruitment for this medical experiment is still active. The investigation was first advertised on June 16th 2022 and has been modified as recently as August 23rd 2022. 30 participants are required from one location only for this trial to occur."
Answered by AI
How many participants will be included in this scientific experiment?
"Affirmative. According to the clinicaltrials.gov records, this medical trial launched on June 16th 2022 and is still accepting applicants as of August 23rd 2022; 30 patients are required at a single site for participation."
Answered by AI
Am I an eligible participant in this medical study?
"This medical trial is actively looking for 30 people with a diagnosis of eosinophilic esophagitis, aged between 6 and 25. The prerequisites are as follows: male or female age 6 to 25 years; an endoscopy displaying more than 15 eosinophils per high powered field which meets the consensus criteria for EoE; either milk, egg, soy or wheat induced EoE within the past two years due to addition/removal of single food source leading to exacerbation/normalization respectively; reintroduction of same food items in last 12 months along with corresponding symptoms; stable dose Proton Pump"
Answered by AI
Is this study taking partakers aged over 40?
"Patients between the ages of 6 and 25 are eligible to participate in this medical study."
Answered by AI
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