Effects of Gluten Digestion With ALV003 (0801)

Alvine Pharmaceuticals

Status: Completed

Conditions: Celiac Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT00859391

ALV0801

Details and patient eligibility

About

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.

Full description

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

1 - Active

Description:

This group received gluten pre-treated with ALV003

2 - Placebo

Description:

This group received Gluten pre-treated with placebo.