A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis
Not Applicable
Not yet recruiting
- Conditions
- Eosinophilic Esophagitis (EoE)
- Interventions
- Registration Number
- NCT07112378
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
Inclusion 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 the protocol
Key
Exclusion Criteria
- 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
- Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline standard of care endoscopy
NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dosing Regimen 1 dupilumab - Dosing Regimen 2 dupilumab -
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent Serious Adverse Events (SAEs) Up to 24 Weeks
- Secondary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events (TEAEs) leading to permanent discontinuation of study treatment Up to 24 Weeks Incidence of treatment-emergent Adverse Event of Special Interest (AESIs) Up to 24 Weeks Incidence of TEAEs Up to 24 Weeks Proportion of patients achieving peak esophageal intraepithelial eosinophil count of <15 eos/hpf (400×) At Week 24 Incidence of Anti-Drug Antibody (ADA) to dupilumab Up to Week 36 Incidence of Neutralizing Antibody (NAb) to dupilumab Up to Week 36 Proportion of patients achieving peak esophageal intraepithelial eosinophil count of ≤6 eosinophils per high power field (eos/hpf) (400×) At Week 24 Percent change in peak esophageal intraepithelial eosinophil count (eos/hpf) Baseline to Week 24 Titer of ADA to dupilumab Up to Week 36 Change in body weight for age percentile Baseline up to Week 24 Concentrations of functional dupilumab in serum Baseline up to Week 24