Eosinophilic Esophagitis study: Dupilumab
Official title A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis
ClinicalTrials.gov ID: NCT07112378
What this study is testing
What is dupilumab?
This is an investigational injectable medicine being studied to see if it can help treat eosinophilic esophagitis in children. It is designed to block specific proteins in the body that cause inflammation.
Also referred to as Dupixent.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if the drug dupilumab is safe and works well for treating active eosinophilic esophagitis (EoE). It also checks for side effects and how the body reacts to the medicine.
- Who it's for
- The study is looking for small children who have active eosinophilic esophagitis (EoE), a condition where the esophagus is inflamed due to an allergic reaction.
- What's involved
- Participants will receive injections of dupilumab for 24 weeks. They will also have regular check-ups and blood tests to monitor their health and how their body handles the drug.
- Time commitment
- The study lasts for 24 weeks and requires regular visits to the clinic for treatments and tests.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 6
You may be able to join if
- 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...
You likely can't join if
- 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.
- Other causes of esophageal eosinophilia or the following conditions: eosinophilic gastroenteritis, hypereosinophilic syndrome, and eosinophilic...
- 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...
See the full eligibility criteria
- 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...
- 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.
- 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
- Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline standard of care endoscopy NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Charleston, South Carolina, United States
- Fort Worth, Texas, United States
- Charlottesville, Virginia, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 6 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; San Francisco, California, United States; Aurora, Colorado, United States; Atlanta, Georgia, United States; Boston, Massachusetts, United States; New York, New York, United States and 7 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.