A Phase 1b/2 Trial Evaluating the Safety, Pharmacokinetics, and Efficacy of EP 104GI in Adults with Eosinophilic Esophagitis (RESOLVE)

Eosinophilic esophagitis

Frequency and severity of treatment-emergent adverse events (TEAEs), Change from baseline in clinical safety laboratory measurements, Change from baseline in morning serum cortisol levels 24 hours postdose and timepoints up to 52 Weeks postdose (dependent on the portion of the study participated in), Change from baseline in vital signs at 1 and 24 hours postdose and timepoints up to 52 Weeks postdose (dependent on the portion of the study participated in)., Plasma concentrations of FP, measured at baseline (predose), 2 and 24 hours postdose, and timepoints up to 52 Weeks postdose (dependent on the portion of the study participated in)

Change from baseline in EoE Histology Scoring System (EoEHSS) grade and stage scores at timepoints up to 52 Weeks postdose (dependent on the portion of the study participated in), Histological response mapped over the surface of the esophagus as a function of proximity to, and size of dose, measured by peak eosinophil count (PEC) at timepoints up to 52 Weeks postdose (dependent on the portion of the study participated in), Change from baseline in the EoE Endoscopic Reference Score (EREFS) at timepoints up to 52 Weeks postdose (dependent on the portion of the study participated in), Change from baseline in the Straumann Dysphagia Index (SDI) patient reported outcome (PRO) score at timepoints up to 52 Weeks postdose (dependent on the portion of the study participated in), Change from baseline in the Dysphagia symptom questionnaire (DSQ) v4.0 and "Dysphagia days" at timepoints up to 52 Weeks postdose (randomized portion of the study only), Change from baseline in Patient Global Impression of Change and Patient Global Impression of Severity (PGIC/PGIS) at timepoints up to 52 Weeks postdose (randomized portion of the study only), Change from baseline in dysphagia measured on an 11 point Likert scale at timepoints up to 52 Weeks postdose (dependent on the portion of the study participated in), Change from baseline in odynophagia measured on an 11 point Likert scale at timepoints up to 52 Weeks postdose (dependent on the portion of the study participated in), Change from baseline in the Eosinophilic Esophagitis Impact Questionnaire (EOE-IQ) at timepoints up to 52 Weeks postdose (randomized portion of the study only)

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