dupilumab: Administered as defined in the protocol
Study 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.
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)
Eligibility
Sex
ALL
Min age
6 Months
Max age
6 Years
Healthy volunteers
No
Key Inclusion Criteria:
1. Pediatric patients aged ≥6 months and weighing ≥5 kg and \<15 kg at screening with active EoE
2. 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
3. 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:
1. Prior participation in a dupilumab clinical trial or past or current treatment with dupilumab
2. 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
3. Other causes of esophageal eosinophilia or the following conditions: eosinophilic gastroenteritis, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)
4. Active Helicobacter pylori infection
5. History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery
6. Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening
7. 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
8. Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline standard of care endoscopy
NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
Primary outcome measure(s)
Incidence of treatment-emergent Serious Adverse Events (SAEs) — Up to 24 Weeks
Trial sites (13)
Facility
City
Region
Status
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
Medical College of Wisconsin, Children's Hospital of Wisconsin
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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