Optimization of Dupilumab Maintenance Dosing in Eosinophilic Esophagitis: A Phase IV, Randomized, Controlled, Single-Blind, Non-Inferiority Study

Conditions

Eosinophilic Esophagitis

Brief summary

Proportion of patients with eosinophilic esophagitis maintaining complete remission at Week 52.

Detailed description

Proportions of patients maintaining clinical, endoscopic, and histologic remission individually at Week 52., Time to loss of complete remission (clinical, endoscopic, and histologic) and of individual clinical, endoscopic, and histologic remission., Number of adverse events (AEs), severe adverse events (SAEs), serious adverse events and suspected unexpected serious adverse events (SUSARs), categorized according to the medical dictionary for regulatory activities (MedDRA)., Health-related quality of life as measured by the validated EoE-QoL-A questionnaire., Health utility values and QALYs measured by EQ-5D-5L., Healthcare resource utilization & productivity impacts measured using adapted iMCQ and iPCQ., Exploratory analyses of biomarkers collected from esophageal biopsies and peripheral blood to identify early predictors of loss of remission during dupilumab dose de-escalation.

Related papers

No related papers found yet.

Interventions

DRUGDUPILUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of patients with eosinophilic esophagitis maintaining complete remission at Week 52.	—

Secondary

Measure	Time frame
Proportions of patients maintaining clinical, endoscopic, and histologic remission individually at Week 52., Time to loss of complete remission (clinical, endoscopic, and histologic) and of individual clinical, endoscopic, and histologic remission., Number of adverse events (AEs), severe adverse events (SAEs), serious adverse events and suspected unexpected serious adverse events (SUSARs), categorized according to the medical dictionary for regulatory activities (MedDRA)., Health-related quality of life as measured by the validated EoE-QoL-A questionnaire., Health utility values and QALYs measured by EQ-5D-5L., Healthcare resource utilization & productivity impacts measured using adapted iMCQ and iPCQ., Exploratory analyses of biomarkers collected from esophageal biopsies and peripheral blood to identify early predictors of loss of remission during dupilumab dose de-escalation.	—

Measure

Time frame

Proportions of patients maintaining clinical, endoscopic, and histologic remission individually at Week 52., Time to loss of complete remission (clinical, endoscopic, and histologic) and of individual clinical, endoscopic, and histologic remission., Number of adverse events (AEs), severe adverse events (SAEs), serious adverse events and suspected unexpected serious adverse events (SUSARs), categorized according to the medical dictionary for regulatory activities (MedDRA)., Health-related quality of life as measured by the validated EoE-QoL-A questionnaire., Health utility values and QALYs measured by EQ-5D-5L., Healthcare resource utilization & productivity impacts measured using adapted iMCQ and iPCQ., Exploratory analyses of biomarkers collected from esophageal biopsies and peripheral blood to identify early predictors of loss of remission during dupilumab dose de-escalation.

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Outcome results

None listed