A Six Month, Safety Follow-up Study in Eosinophilic Esophagitis Subjects Who Completed Study PR-021

Study Overview
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Brief Summary
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This purpose of this study is the long-term follow-up of glucocorticosteroid-related adverse events and hypothalamic-pituitary-adrenal axis (HPA) suppression in subjects after discontinuation of study drug received in the PR-021 study (Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis). The study will also provide the opportunity to better understand the natural course of eosinophilic esophagitis and define the treatment modalities of eosinophilic esophagitis with EUR-1100, such as the need for chronic maintenance or intermittent treatment. All subjects who complete PR-021 will be offered the opportunity to participate in this study. The duration of this follow-up study is six months, during which subjects will visit the clinic for safety evaluation and clinical symptom assessment at the screening, Week 8, Week 16, and Week 24 visits. Additional phone visits will occur at Week 4, Week 12, and Week 20.

Official Title
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Six Month Safety Follow-up Study for PR-021 [Multicenter, Randomized, Double-blind, Placebo-controlled, Safety and Tolerability Phase 1/2a Study of Two Dosing Regimens of EUR-1100 for Oral Use, in Eosinophilic Esophagitis Subjects]

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Drug: EUR-1100
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject completed full participation in Study PR-021 (Subjects discontinued prematurely from PR-021 due to HPA axis suppression will be eligible for study PR-022) Written informed consent (parent or legal guardian must sign when applicable) and assent form, if required Willing and able to adhere to all study procedures Exclusion Criteria: Subjects already requiring medications or procedures for the treatment of EoE at the time of enrollment into the follow-up study, such as systemic (oral or parenteral) or inhaled corticosteroids, esophageal dilation, Proton Pump Inhibitors (PPIs) and/or dietary restrictions; in the case of subjects already on PPIs and /or dietary restrictions during Study PR-021, only subjects requiring an increase in dosage of PPIs and/or new dietary restrictions because of worsening of symptoms will be excluded Any physical, mental, or social condition, history or concurrent illness or laboratory abnormality that, in the investigator's judgment, might interfere with study procedures or the ability of the subject to adhere to and complete the study Contraindication to esophagogastroduodenoscopy (EGD) or esophageal biopsy or narrowing of the esophagus precluding EGD Female subjects who are pregnant or breastfeeding Participation in a clinical study involving an investigational drug or investigational device

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 55 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PR-021 Eosinophilic Esophagitis (EoE) Subjects<br>Subjects who received study drug and completed PR-021 study | Drug: EUR-1100<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morning serum cortisol (change from baseline measure) |  | Baseline, Week 8, Week 16, and Week 24 | 
| Standard safety laboratory tests (change from baseline measure) | Hematology, serum chemistry, liver function tests, urinalysis, urine chemistry | Baseline, Week 8, Week 16, and Week 24 | 
| Treatment-emergent adverse events collection (change from baseline measure) |  | Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | 
| Physical examination and vital signs collection (change from baseline measure) |  | Baseline, Week 8, Week 16, and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophagoduodenoscopy with multiple biopsies |  | Week 24 | 
| Patient reported outcomes and physician global assessment |  | Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 |