Safety and Efficacy of Varying Methods of ALV003 Administration for the Treatment of Celiac Disease

Study Overview
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Brief Summary
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A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.

Official Title
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A Phase 2a, Double-Blind, Placebo Controlled Study of the Efficacy, Safety and Tolerability of 6-weeks Treatment With Varying Methods of ALV003 Administration in Patients With Well-Controlled Celiac Disease

Conditions
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Celiac Disease

Intervention / Treatment
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* Biological: ALV003
* Biological: ALV003 placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of biopsy-proven celiac disease Adherence to a gluten-free diet TG2 antibody negative Signed informed consent Exclusion Criteria: Active dermatitis herpetiformis History of IgE-mediated reactions to gluten Use of specific medications 6 months prior to entry History of alcohol abuse or illicit drug use Current untreated or GI disease Positive pregnancy test Received any experimental drug within 14 days of randomization Uncontrolled chronic disease or condition Uncontrolled complications of celiac disease Any medical condition which could adversely affect study participation

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALV003<br>ALV003 is an orally administered mixture of two recombinant proteases (cysteine endoprotease B-isoform 2 and prolyl endopeptidase) engineered to degrade gluten into non-immunogenic fragments, by targeting the glutamine and proline residues common in gluten. | Biological: ALV003<br> <br> |
| Placebo Comparator: Placebo<br>Excipients for ALV003 absent the experimental compounds | Biological: ALV003 placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Intestinal mucosal morphology | Intestinal mucosal morphology - change from baseline to week 6 | 6 weeks | 
| Safety: Tolerability of ALV003 | Safety will be evaluated by collection of adverse events, blood chemistry and blood cell counts | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype | Intestinal intraepithelial lymphocyte numbers/phenotype - change from baseline to week 6 | 6 weeks | 
| Efficacy: Change in serological markers of celiac disease | Serological markers of celiac disease - change from baseline to week 6 | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Celiac Disease, Coeliac Disease, Celiac Sprue, Keliakia Disease