A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of the Efficacy and Safety of ALV003 Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet
Rochester, Minn., Jacksonville, Fla., Phoenix/Scottsdale, Ariz.
Trial status: Open for Enrollment
Why is this study being done?
To determine the effects of 12 weeks administration of different dose levels of ALV003 on the mucosal lining of the small intestine and symptoms in celiac disease patients.
Who is eligible to participate?
- Ages 18 to 80 years
- Physician diagnosed celiac disease
- Adherence to a gluten-free diet
- Experiencing symptoms of celiac disease over a 1-month period
- Willing to take study medication for 12 weeks
- Willing to comply with all study procedures
- Sign informed consent
- Active inflammatory bowel disease
- Active dermatitis herpetiformis
- Use of certain specific medications prior to entry
- History of alcohol or illicit drug abuse in previous 6 months
- Pregnant or lactating
- Received any experimental drug within 30 days of enrollment
- Uncontrolled chronic disease or condition