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A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis

RecruitingPhase 3Ages 6 Months - 6 YearsAllRegeneron Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: 1. Pediatric patients aged โ‰ฅ6 months and weighing โ‰ฅ5 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
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What it tests

  • dupilumab
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Where

13 sites
Phoenix Childrens Hospital
Phoenix, United States
University of California San Francisco (UCSF)
San Francisco, United States
Children's Hospital Colorado
Aurora, United States
GI Care for Kids LLC
Atlanta, United States
Massachusetts General Hospital
Boston, United States
Weill Cornell Medicine
New York, United States
University of North Carolina, Bioinformatics Building
Chapel Hill, United States
Children's Hospital of Philadelphia
Philadelphia, United States

โ€ฆand 5 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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