A Phase 3 interventional study of dupilumab in Eosinophilic Esophagitis (EoE), sponsored by Regeneron Pharmaceuticals. Recruiting at 13 sites in United States. Open to participants aged 6 Months to 6 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment
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Among 11 studies testing dupilumab in Eosinophilic Esophagitis — 4 open to participants now, 7 under way, 1 of them phase 3. dupilumab · Eosinophilic Esophagitis.
Among the 11 studies testing dupilumab in Eosinophilic Esophagitis, this one is the 11th largest by planned enrollment, is the only one that started in 2025, is one of 3 in phase 3, and was the 10th registered.
235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.
Browse Eosinophilic Esophagitis studies →4 of the 11 studies testing dupilumab in Eosinophilic Esophagitis are open now, in 1 country. Recruiting first, the newest first:
University of Colorado, Denver · Sites in United States
Ages 12–25
University of California, San Diego · Sites in United States
Ages 22+
Mayo Clinic · Sites in United States
Ages 18+
By country, each count listing its studies:
dupilumab: first FDA approval 2017 (DUPIXENT), first EMA approval 2017. What it is approved for, and how studies give it, is on its page →
Of the 42 Eosinophilic Esophagitis studies recruiting now, 12 (29%) set no upper age limit and 27 (64%) stop at 75 or younger; 27 take children under 18; 7 take healthy volunteers.
This study: 6 Months to 6 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, dupilumab is the treatment under test here. Read study by study →
11 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 1 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 42 across 134 interventional studies indexed under Eosinophilic Esophagitis.
Median enrollment 47 across the 11 interventional studies. Of the 4 that completed or were terminated, 4 (100%) have results posted.
This tab as a report to print or save as PDF → With an account.
6 of 11 have an industry lead sponsor. The 7 most frequent:
Regeneron Pharmaceuticals is the lead sponsor of 412 studies on the registry; 90 are open to participants now.
Of its 126 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.
Regeneron Pharmaceuticals has 7 studies filed under Eosinophilic Esophagitis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies testing dupilumab in Eosinophilic Esophagitis, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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:
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: dupilumab
Drug: dupilumab
Administered as defined in the protocol
Also known as: DUPIXENT®, REGN668, SAR231893
Incidence of treatment-emergent Serious Adverse Events (SAEs)
Time frame: Up to 24 Weeks
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
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: When Regeneron has: received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) the legal authority to share the data, and ensured the ability to protect participant privacy
Access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Jun 2028, 31 months after the start.
Of 16 phase 3 interventional studies under Eosinophilic Esophagitis, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 37. This study's planned 31 months is close to that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Dupilumab