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

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

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

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