Eosinophilic esophagitis
Conditions
Brief summary
Proportion of patients achieving peak esophageal intraepithelial eosinophil count of ≤6 eos/hpf at week 12.
Detailed description
Change in total EoE-Dysphagia Assessment Questionnaire (EDAQ) score from baseline to week 12., Change inEosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) from baseline to week 12., Percent change in peak esophageal intraepithelial eosinophil count (eos/hpf)., Change in EoE Grade Score from the Histology Scoring System (EoE-HSS) from baseline to week 12., Change in EoE Stage Score from the EoE-HSS from baseline to week 12.
Interventions
DRUGMatching orodispersible placebo tablet
Sponsors
Bioprojet Pharma
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving peak esophageal intraepithelial eosinophil count of ≤6 eos/hpf at week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in total EoE-Dysphagia Assessment Questionnaire (EDAQ) score from baseline to week 12., Change inEosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) from baseline to week 12., Percent change in peak esophageal intraepithelial eosinophil count (eos/hpf)., Change in EoE Grade Score from the Histology Scoring System (EoE-HSS) from baseline to week 12., Change in EoE Stage Score from the EoE-HSS from baseline to week 12. | — |
Countries
France, Italy
Outcome results
None listed