Table 4.

Relevant clinical trials in EoE and EGID.

Author	Year	Study design	Condition	Study population	Drug	Dose	Primary outcome	Secondary outcome
Assa'ad53	2011	Multicenter RDB	EoE	-59 children age 2-17with EoE refractory to medical therapy	Mepolizumab	-0.55 mg/kg every 4 weeks -2.5 mg/kg every 4 weeks -10 mg/kg every 4 weeks	-Proportion of patients with esophageal eosinophil count <5/hpf at week 12 -Safety, tolerability, pharmacokinetics	-Changes in peak and mean intraepithelial eosinophil counts -improvement in histopathological and endoscopic findings -AEC -Frequency and severity of symptoms
Spergel54	2012	Multicenter RDBPC	EoE	-227 patients age 5–18 with moderate EoE	Reslizumab	-1–3 mg/kg every 4 weeks for 16 weeks	-% change in peak esophageal eosinophil count -change in physician's EoE global assessment score	-Patient's EoE predominant symptoms -CHQ
Dellon60 (ENIGMA)	2020	Phase 2 multicenter RDBPC	EGID	-65 patients age 18–80 with eosinophilic gastritis/duodenitis inadequately controlled with medication or dietary modification	Lirentelimab	-High dose: 0.3, 1, 3, 3 mg/kg -Low dose: 0.3, 1, 1, 1 mg/kg -4 IV doses given every 4 weeks	-% change in mean peak gastric/duodenal eosinophil count	-Treatment response (>30% reduction in total symptom score AND >75% reduction in gastrointestinal eosinophilia count) -% change in total symptom score

Abbreviations: EoE, Eosinophilic esophagitis; EGID, eosinophilic gastrointestinal disease AEC, Absolute eosinophil count; RDBPC, randomized, double-blind, placebo-controlled; HPF, high-power field; RDB, Randomized, double-blind; CHQ, children's health questionnaire; CUP, compassionate use protocol