Proof of Concept Study of OC000459 in Eosinophilic Esophagitis

Phase 2

Completed

• Conditions: Eosinophilic Esophagitis
• Interventions: Drug: Placebo; Drug: OC000459

• Registration Number: NCT01056783
• Lead Sponsor: Oxagen Ltd

Brief Summary

This will be a randomised, double blind, placebo controlled, parallel group evaluation of the effect of OC000459 given orally for eight weeks on active eosinophilic esophagitis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Study Start: 2010-08
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-04
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Previously diagnosed and symptomatic isolated eosinophilic esophagitis.
• Relevant eosinophil tissue inflammation as demonstrated by a mean eosinophil load >= 20 eos/hpf in 8 biopsies at the baseline visit.
• Able to swallow placebo medication successfully under supervision in the clinic
• Free of all medications for EoE (including topical steroids) for at least 2 weeks prior to baseline and free of systemic steroids for at least 90 days before screening. A proton-pump inhibitor is allowed if required for treatment of secondary acid reflux.

Exclusion Criteria

• Other causes of esophagitis (GERD, peptic ulceration, infection etc.)
• Other causes of eosphagaeal or generalized eosinophilia (i.e. hypereosinophilic syndromes, parasitic infection, GERD)
• The patient's EoE is dependant on the level of seasonal allergens and the patient's participation in the study will occur during the allergy season.
• History of abnormal gastric or duodenal eosinophilia (e.g. HES, Churg Strauss vasculitis, EG or a parasitic infection)
• Receipt of forbidden prescribed or over the counter medication within the 4 weeks prior to the baseline visit and for the duration of the trial, including vitamins and herbal remedies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
OC000459	OC000459	OC000459 100mg twice daily

Primary Outcome Measures

Name	Time	Method
Effect of OC000459 on eosinophil load of the esophageal tissue	8 weeks

Secondary Outcome Measures

Name	Time	Method
Effect of OC000459 on clinical manifestations of EoE	8 weeks
Effect of OC000459 on endoscopic alterations	8 weeks
Effect of OC000459 on EoE related blood and tissue biomarkers	8 weeks
Safety and tolerability of OC000459 in patients with active EoE	8 weeks

Trial Locations

Locations (1)

Swiss EoE Research Group; 🇨🇭 Olten, Switzerland