Proof of Concept Study of OC000459 in Eosinophilic Esophagitis

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Placebo-controlled, Double-blind, Single-centre Proof-of-concept Study of OC000459 in Adult Patients With Active Eosinophilic Esophagitis

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Drug: OC000459
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OC000459<br>OC000459 100mg twice daily | Drug: OC000459<br>* OC000459 100mg, twice daily, tablet<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo tablets to match OC000459 tablets, twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of OC000459 on eosinophil load of the esophageal tissue |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EoE