Effects of Gluten Digestion With ALV003

Study Overview
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Brief Summary
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This is a Phase 0, Double-blind study that will assess the effect of in vitro treatment of gluten with ALV003 or with placebo when ingested by CD Subjects.

Detailed Description
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The primary objective of this study is to compare the effects of gluten treated with ALV003 vs placebo: The clinical response by symptom measurement before and after oral challenge The immune response measured by ELISPOT testing and serology The secondary objective of the study is to Describe the immunotoxic epitope profile of gluten digests with ALV003 compared with placebo

Official Title
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A Phase 0 Study in Subjects With Well Controlled Celiac Disease to Assess the Effects of Gluten Digestion With ALV003 (a Protease Enzyme) in Vitro

Conditions
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Celiac Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75 years Well controlled Celiac Disease without flare in symptoms for the past 8 weeks History of biopsy proven Celiac Disease Able and willing to complete a symptom diary for 3 days prior and through 3 days post gluten challenge Been on a gluten free diet for 8 weeks prior to study entry Have normal celiac serology (anti- tTG level of <20 units/mL) Exclusion Criteria: Uncontrolled complications of celiac disease which in the opinion of the Investigator would impact their immune response, or pose an increased risk to the subject. (example: like type 1 diabetes or other autoimmune disease) Pregnant or breast feeding women, subjects of childbearing potential to use two methods of contraception Concomitant medications such as over the counter digestive enzymes, immunosuppressive therapies, anticoagulants, NSAIDs. Chronic medications for well-controlled chronic conditions are allowed. Clinically significant abnormal lab values, as determined by the PI: Untreated or active peptic ulcer disease, esophagitis, motility disorders or any gastrointestinal diseases. Positive pregnancy test within 7 days prior to study drug administration Known allergy or hypersensitivity to E.coli or E.coli derived proteins

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 - Active<br>This group received gluten pre-treated with ALV003 | |
| 2 - Placebo<br>This group received Gluten pre-treated with placebo. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clinical response by symptom measurement before and after oral challenge |  | Day 1 and Day 6 | 
| The immune response measured by ELISPOT testing and celiac disease serology |  | Prior to and post 3-day gluten challenge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the immunotoxic epitope profile of gluten digests with ALV003 compared with placebo |  | Day 1 and Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Celiac Disease