Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)

  • STATUS
    Recruiting
  • End date
    Aug 29, 2023
  • participants needed
    90
  • sponsor
    Regeneron Pharmaceuticals
Updated on 26 May 2021
Investigator
Clinical Trials Administrator
Primary Contact
Regeneron Study Site (6.4 mi away) Contact
+17 other location

Summary

The Primary objective is to demonstrate the efficacy of dupilumab treatment compared with placebo in pediatric patients with active eosinophilic esophagitis (EoE) based on histologic improvement meeting validated histologic criteria.

The Secondary objectives are:

  • To demonstrate the efficacy of dupilumab compared to placebo in pediatric patients with active EoE after 16 weeks of treatment as assessed by endoscopic visual measurements of disease activity using the Eosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) and histologic abnormalities as measured by the EoE Histology Scoring System (EoE-HSS)
  • To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 16 weeks in pediatric patients with active EoE
  • To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation
  • To study the effects of dupilumab on the type 2 inflammation gene expression signature
  • To evaluate the concentration-time profile of functional dupilumab in serum in this population
  • To assess efficacy of long-term (52 weeks) dupilumab treatment
  • To assess safety, tolerability, and immunogenicity of long-term (52 weeks) dupilumab treatment
  • To evaluate the impact of dupilumab treatment on EoE signs and symptoms

Details
Condition Eosinophilic esophagitis
Treatment Matching Placebo, Dupilumab
Clinical Study IdentifierNCT04394351
SponsorRegeneron Pharmaceuticals
Last Modified on26 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

A documented diagnosis of eosinophilic esophagitis (EoE)
Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration

Exclusion Criteria

Body weight <5 kg or 60 kg at screening
Other causes of esophageal eosinophilia
Active Helicobacter pylori
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
Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline standard of care endoscopy
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 endoscopy procedure
Active parasitic infection or suspected parasitic infection
Known or suspected immunodeficiency disorder
NOTE: Other protocol defined inclusion/exclusion criteria apply
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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