OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension

Summary

This is a clinical trial to test an experimental drug for the treatment of Eosinophilic Esophagitis (EoE)

Timeline

Start

2012-07-23

Primary completion

2014-10-30

Completion

2014-10-30

Outcome

Met primary endpoint

registry analysis (unspecified test); Double-blind Placebo vs Double-blind Oral Budesonide Suspension (OBS) 2 mg; p <0.0001; Fisher Exact NCT01642212 ↗

registry p = 0.0096; LS mean difference -6.75 (95% CI -11.808 to -1.687) NCT01642212 ↗

paper For BOS vs placebo, change in DSQ score was -14.3 vs -7.5 (P = .0096) PMID 27889574 ↗

paper histologic response rates were 39% vs 3% (P < .0001) PMID 27889574 ↗

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.
• 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, Hudgens S, Lan L, Williams J, Vera-Llonch M, Hirano I. Improvements in Dysphagia and Pain With Swallowing in Patients With Eosinophilic Esophagitis Receiving Budesonide Oral Suspension. Clin Gastroenterol Hepatol. 2021 Apr;19(4):699-706.e4. doi: 10.1016/j.cgh.2020.03.060. Epub 2020 Apr 6.
• Hirano I, Dellon ES, Collins MH, Williams J, Lan L, Katzka DA. Clinical Features at Baseline Cannot Predict Symptom Response to Placebo in Patients With Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2019 Sep;17(10):2126-2128.e1. doi: 10.1016/j.cgh.2018.11.045. Epub 2018 Nov 28.
• Dellon ES, Katzka DA, Collins MH, Gupta SK, Lan L, Williams J, Hirano I. Safety and Efficacy of Budesonide Oral Suspension Maintenance Therapy in Patients With Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2019 Mar;17(4):666-673.e8. doi: 10.1016/j.cgh.2018.05.051. Epub 2018 Jun 12.
• Dellon ES, Katzka DA, Collins MH, Hamdani M, Gupta SK, Hirano I; MP-101-06 Investigators. Budesonide Oral Suspension Improves Symptomatic, Endoscopic, and Histologic Parameters Compared With Placebo in Patients With Eosinophilic Esophagitis. Gastroenterology. 2017 Mar;152(4):776-786.e5. doi: 10.1053/j.gastro.2016.11.021. Epub 2016 Nov 23.

Drugs

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

Indications