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Eosinophilic Esophagitis clinical trials at UCSF

3 in progress, 2 open to eligible people

Showing trials for
  • Assessing Esophageal Function and Remodeling With Dupilumab Compared With Placebo for 24 Weeks Followed by 104 Weeks Open Label in Adult Participants With EoE (REMOdeling With Dupilumab in Eosinophilic Esophagitis Long-term Trial)

    open to eligible people ages 18 years and up

    This is parallel, Phase 4 study which consists of a 24 week (0.5 years) randomized, double blind, placebo controlled, 2-arm treatment period followed by an open label segment of 104 weeks (2 years) for a total of 128 weeks (2.5 years) to evaluate the effect of dupilumab treatment on esophageal function, and remodeling in adults with eosinophilic esophagitis. Duration of study period (per participant) - Screening period: Up to 12 weeks before Week 0 - Randomized double-blind period: 24 weeks - Open label period: 104 weeks - Post Investigational Medicinal Product (IMP) intervention follow-up period: up to 12 weeks or until the participants switch to commercialized dupilumab, whatever comes first. There will be ten (10) site visits, and five (5) direct-to-participant IMP delivery visits (except if prohibited by local regulatory authorities or if participant is not willing. In this case, IMP will be dispensed at the study site).

    San Francisco, California and other locations

  • Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis

    open to eligible people ages 12 years and up

    The study is researching an experimental drug called dupilumab. The study is focused on participants with active eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD are uncommon, persistent, allergic/immune diseases in which eosinophils (a type of white blood cell) gather in large numbers in the stomach and small intestine and cause inflammation and damage. The aim of the study is to evaluate the effect of dupilumab on relieving EoG (with or without EoD) symptoms and reducing inflammation in the stomach and, if applicable, small intestine in adults and adolescents aged 12 years and older, compared to placebo. 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 your 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)

    San Francisco, California and other locations

  • Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)

    Sorry, in progress, not accepting new patients

    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 (up to 160 weeks) dupilumab treatment - To assess the impact of dupilumab treatment on changes in weight and growth during the extended active period and open-label extension period of the study - To assess safety, tolerability, and immunogenicity of long-term (up to 160 weeks) dupilumab treatment - To evaluate the impact of dupilumab treatment on EoE signs and symptoms

    San Francisco, California and other locations

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