Eosinophilic Esophagitis (EoE)Phase 3EoE-TOTsNCT07112378
A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis
A Phase 3 study testing dupilumab in people with Eosinophilic Esophagitis (EoE), run by Regeneron Pharmaceuticals at 13 sites in United States.
Trial summary
This study is researching an experimental drug called dupilumab (called "study drug"). The study is focused on children with active eosinophilic esophagitis (EoE; an inflammatory disease of the esophagus) which impacts feeding and nourishment. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Eosinophilic Esophagitis (EoE)
- What is being tested?
- dupilumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 13 sitesUnited States
- Study dates
- 10 Nov 2025to 9 Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged ≥6 months and weighing ≥5 kg and <15 kg at screening with active EoE
- History of symptom(s) determined by the investigator to be the result of EoE in the month prior to screening, as defined in the protocol
- Baseline endoscopic biopsies, performed during the screening period, with a demonstration on central reading of intraepithelial eosinophilic infiltration in at least 2 of the 3 biopsied esophageal regions, as defined in the protocol
Who cannot join
- 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. Patients on a food-elimination diet must remain on the same diet throughout the study
- Other causes of esophageal eosinophilia or the following conditions: eosinophilic gastroenteritis, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)
- Active Helicobacter pylori infection
- History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery
- Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening
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- History of bleeding disorders or esophageal varices that, in the opinion of the investigator, would put the patient at undue risk for significant complications from an endoscopic procedure
- Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline standard of care endoscopy
- NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
GI Care for Kids LLC
Atlanta, Georgia, 30342
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
University of North Carolina, Bioinformatics Building
Chapel Hill, North Carolina, 27599
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
- Recruiting
Cook Children's Medical Center
Fort Worth, Texas, 76104
- Recruiting
Medical College of Wisconsin, Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
- Recruiting
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
- Recruiting
University of California San Francisco (UCSF)
San Francisco, California, 94143
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: A Randomized Study Evaluating 2 Dose Regimens of Dupilumab in Children ≥6 Months of Age Weighing ≥5 to <15 kg With Active Eosinophilic Esophagitis
This study is researching an experimental drug called dupilumab (called "study drug"). The study is focused on children with active eosinophilic esophagitis (EoE; an inflammatory disease of the esophagus) which impacts feeding and nourishment.
The aim of the study is to see how safe, tolerable, and effective the study drug is when given for 24 weeks to children with active EoE.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
- Conditions
- Eosinophilic Esophagitis (EoE)
- Being tested
- dupilumab
- Keywords
- Type 2 Inflammatory, Allergic/immune-mediated, Esophageal dysfunction
- Medical subject headings
- Eosinophilic Esophagitis, Esophageal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dupilumabDrug
Also called DUPIXENT®, REGN668, SAR231893
Administered as defined in the protocol
| Study group | Role | What they receive |
|---|---|---|
| Dosing Regimen 1 | Experimental | Not described Receives: Drug: dupilumab |
| Dosing Regimen 2 | Experimental | Not described Receives: Drug: dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent Serious Adverse Events (SAEs)
Measured: Up to 24 Weeks
Secondary outcomes (11)
Incidence of Treatment-Emergent Adverse Events (TEAEs) leading to permanent discontinuation of study treatment
Measured: Up to 24 Weeks
Incidence of treatment-emergent Adverse Event of Special Interest (AESIs)
Measured: Up to 24 Weeks
Incidence of TEAEs
Measured: Up to 24 Weeks
Proportion of patients achieving peak esophageal intraepithelial eosinophil count of ≤6 eosinophils per high power field (eos/hpf) (400×)
Measured: At Week 24
Proportion of patients achieving peak esophageal intraepithelial eosinophil count of <15 eos/hpf (400×)
Measured: At Week 24
Percent change in peak esophageal intraepithelial eosinophil count (eos/hpf)
Measured: Baseline to Week 24
Change in body weight for age percentile
Measured: Baseline up to Week 24
Concentrations of functional dupilumab in serum
Measured: Baseline up to Week 24
Incidence of Anti-Drug Antibody (ADA) to dupilumab
Measured: Up to Week 36
Titer of ADA to dupilumab
Measured: Up to Week 36
Incidence of Neutralizing Antibody (NAb) to dupilumab
Measured: Up to Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start10 Nov 2025
- Primary completion19 Jun 2028 (estimated)
- Study completion9 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic Esophagitis (EoE)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112378
- Sponsor's protocol ID
- R668-EE-2423
- Acronym
- EoE-TOTs
- Status last verified
- Sep 2026
- First submitted
- 1 Aug 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Evaluating 2 Dose Regimens of Dupilumab in Children ≥6 Months of Age Weighing ≥5 to <15 kg With Active Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT07112378
- Acronym / sponsor ID
- EoE-TOTs / R668-EE-2423
- Conditions
- Eosinophilic Esophagitis (EoE)
- Keywords
- Type 2 Inflammatory, Allergic/immune-mediated, Esophageal dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 19 Jun 2028 (estimated)
- Study completion
- 9 Oct 2028 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is researching an experimental drug called dupilumab (called "study drug"). The study is focused on children with active eosinophilic esophagitis (EoE; an inflammatory disease of the esophagus) which impacts feeding and nourishment.
The aim of the study is to see how safe, tolerable, and effective the study drug is when given for 24 weeks to children with active EoE.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dosing Regimen 1 | Experimental | Drug: dupilumab |
| Dosing Regimen 2 | Experimental | Drug: dupilumab |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients aged ≥6 months and weighing ≥5 kg and <15 kg at screening with active EoE
- History of symptom(s) determined by the investigator to be the result of EoE in the month prior to screening, as defined in the protocol
- Baseline endoscopic biopsies, performed during the screening period, with a demonstration on central reading of intraepithelial eosinophilic infiltration in at least 2 of the 3 biopsied esophageal regions, as defined in the protocol
Key exclusion criteria (9 listed)
- 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. Patients on a food-elimination diet must remain on the same diet throughout the study
- Other causes of esophageal eosinophilia or the following conditions: eosinophilic gastroenteritis, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)
- Active Helicobacter pylori infection
- History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dupilumabAlso: DUPIXENT®, REGN668, SAR231893Administered as defined in the protocol | Drug | Dosing Regimen 1, Dosing Regimen 2 |
Primary outcome
Incidence of treatment-emergent Serious Adverse Events (SAEs)
Time frame: Up to 24 Weeks
11 secondary outcomes
Incidence of Treatment-Emergent Adverse Events (TEAEs) leading to permanent discontinuation of study treatment
Time frame: Up to 24 Weeks
Incidence of treatment-emergent Adverse Event of Special Interest (AESIs)
Time frame: Up to 24 Weeks
Incidence of TEAEs
Time frame: Up to 24 Weeks
Proportion of patients achieving peak esophageal intraepithelial eosinophil count of ≤6 eosinophils per high power field (eos/hpf) (400×)
Time frame: At Week 24
Proportion of patients achieving peak esophageal intraepithelial eosinophil count of <15 eos/hpf (400×)
Time frame: At Week 24
Percent change in peak esophageal intraepithelial eosinophil count (eos/hpf)
Time frame: Baseline to Week 24
Change in body weight for age percentile
Time frame: Baseline up to Week 24
Concentrations of functional dupilumab in serum
Time frame: Baseline up to Week 24
Incidence of Anti-Drug Antibody (ADA) to dupilumab
Time frame: Up to Week 36
Titer of ADA to dupilumab
Time frame: Up to Week 36
Incidence of Neutralizing Antibody (NAb) to dupilumab
Time frame: Up to Week 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Related trials for Eosinophilic Esophagitis (EoE)
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Natural History and Genetics of Food Allergy and Related Conditions
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Eosinophilic Esophagitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trial Management study director
Regeneron Pharmaceuticals
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dupilumab in people with Eosinophilic Esophagitis (EoE), run by Regeneron Pharmaceuticals at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent Serious Adverse Events (SAEs) (time frame: Up to 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.