A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved

Summary

A study in adolescents and adults with eosinophilic esophagitis (EoE) to measure the histologic response and determine if any reduction in dysphagia is achieved.

Timeline

Start

2015-12-07

Primary completion

2019-01-24

Completion

2019-02-15

Outcome

Met primary endpoint

paper More BOS-treated than placebo-treated patients achieved a stringent histologic response (53.1% vs 1.0%; Δ52% [95% confidence interval (CI), 43.3%-59.1%]; P < .001) PMID 33887475 ↗

paper or symptom response (52.6% vs 39.1%; Δ13% [95% CI, 1.6%-24.3%]; P = .024) over 12 weeks. PMID 33887475 ↗

release “Phase 2 trial in adolescents and adults (ages 11-40) with EoE. The co-primary endpoints were met” takeda.com ↗

Publications

• Dellon ES, Katzka DA, Mukkada VA, Falk GW, Tahir MJ, Gugiu PC, Blau J, Terreri B. Effect of Budesonide Oral Suspension on Time to First Dysphagia Symptom Response and Dysphagia Symptom Resolution Outcomes in Patients With Eosinophilic Esophagitis. J Gastroenterol Hepatol. 2026 Mar;41(3):927-936. doi: 10.1111/jgh.70205. Epub 2026 Feb 19.
• Dellon ES, Collins MH, Katzka DA, Mukkada VA, Falk GW, Zhang W, Goodwin B, Terreri B, Boules M, Desai NK, Hirano I. Effect of randomized treatment withdrawal of budesonide oral suspension on clinically relevant efficacy outcomes in patients with eosinophilic esophagitis: a post hoc analysis. Ther Adv Gastroenterol. 2024 Dec 23;17:17562848241307602. doi: 10.1177/17562848241307602. eCollection 2024.
• Hirano I, Collins MH, Katzka DA, Mukkada VA, Falk GW, Terreri B, Boules M, Zhang W, Desai NK, Dellon ES. Effect of Esophageal Dilation History on Efficacy Outcomes in Patients With Eosinophilic Esophagitis Receiving Budesonide Oral Suspension. Am J Gastroenterol. 2024 Nov 12;120(7):1502-1510. doi: 10.14309/ajg.0000000000003197.
• Mukkada VA, Gupta SK, Gold BD, Dellon ES, Collins MH, Katzka DA, Falk GW, Williams J, Zhang W, Boules M, Hirano I, Desai NK. Pooled Phase 2 and 3 Efficacy and Safety Data on Budesonide Oral Suspension in Adolescents with Eosinophilic Esophagitis. J Pediatr Gastroenterol Nutr. 2023 Dec 1;77(6):760-768. doi: 10.1097/MPG.0000000000003948. Epub 2023 Sep 18.
• Dellon ES, Collins MH, Katzka DA, Mukkada VA, Falk GW, Morey R, Goodwin B, Eisner JD, Lan L, Desai NK, Williams J, Hirano I; ORBIT2/SHP621-302 Investigators. Long-Term Treatment of Eosinophilic Esophagitis With Budesonide Oral Suspension. Clin Gastroenterol Hepatol. 2022 Jul;20(7):1488-1498.e11. doi: 10.1016/j.cgh.2021.06.020. Epub 2021 Jun 26.
• Hirano I, Collins MH, Katzka DA, Mukkada VA, Falk GW, Morey R, Desai NK, Lan L, Williams J, Dellon ES; ORBIT1/SHP621-301 Investigators. Budesonide Oral Suspension Improves Outcomes in Patients With Eosinophilic Esophagitis: Results from a Phase 3 Trial. Clin Gastroenterol Hepatol. 2022 Mar;20(3):525-534.e10. doi: 10.1016/j.cgh.2021.04.022. Epub 2021 Apr 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Budesonide	Small molecule	2 mg	Oral

Indications