Phase 3: testing dupilumab for Eosinophilic Esophagitis (EoE)
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.
Official registry: https://clinicaltrials.gov/study/NCT07112378 · Regeneron Pharmaceuticals · enrollment listed as 20
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are dupilumab. The registry lists allocation as randomized. This study is researching an experimental drug called dupilumab (called "study drug").
They plan to enroll about 20 people at 13 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Randomized Study Evaluating 2 Dose Regimens of Dupilumab in Children ≥6 Months of Age Weighing ≥5 to <15 kg With Active Eosinophilic Esophagitis
Interventions: dupilumab
Primary outcome (registry wording): Incidence of treatment-emergent Serious Adverse Events (SAEs)
Who it is for (from inclusion criteria)
- Ages 6 Months to 6 Years
- 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 the registry excludes
- 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
- 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
Public study contact (from the registry)
Clinical Trials Administrator
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
13 listed- Phoenix Childrens Hospital — Phoenix, Arizona (recruiting)
- University of California San Francisco (UCSF) — San Francisco, California (recruiting)
- Children's Hospital Colorado — Aurora, Colorado (recruiting)
- GI Care for Kids LLC — Atlanta, Georgia (recruiting)
- Massachusetts General Hospital — Boston, Massachusetts (recruiting)
- Weill Cornell Medicine — New York, New York (recruiting)
- University of North Carolina, Bioinformatics Building — Chapel Hill, North Carolina (recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania (recruiting)
- Medical University of South Carolina — Charleston, South Carolina (recruiting)
- Cook Children's Medical Center — Fort Worth, Texas (recruiting)
- University of Virginia — Charlottesville, Virginia (recruiting)
- Seattle Children's Hospital — Seattle, Washington (recruiting)
FAQ about this NCT record
Is NCT07112378 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07112378?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07112378?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary