Proof of Concept Study of OC000459 in Eosinophilic Esophagitis

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01056783

Enrollment

Registered

2010-01-26

Start date

2010-08-31

Completion date

2011-06-30

Last updated

2012-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis

Keywords

EoE

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.

Interventions

DRUGOC000459

OC000459 100mg, twice daily, tablet

DRUGPlacebo

Placebo tablets to match OC000459 tablets, twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Effect of OC000459 on eosinophil load of the esophageal tissue	8 weeks

Secondary

Measure	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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026