The sponsor of this study, Alvine Pharmaceuticals, is developing an experimental drug called ALV003. ALV003 is a mixture of two different enzymes, which in the test tube can break down gluten into smaller pieces of protein. These small protein pieces are expected to be less damaging to the small intestine by reducing or preventing the reaction that occurs when celiac disease patients eat foods that contain gluten. In this study, ALV003 or placebo is to be taken by mouth with each major gluten-free meal. The purpose of this study is to find out if ALV003 is able to improve the damage in the lining of the intestine caused by gluten that often contaminates an attempted gluten-free diet. The study will also evaluate whether ALV003 has an effect on any of the symptoms related to celiac disease and to collect further information on any side effects.
You may be eligible to participate in this study if you:
- Have physician-diagnosed celiac disease with documented biopsy-proven celiac disease
- Have been maintaining a gluten-free diet for at least 11 months
- Experienced at least one self-reported moderate or severe GI symptom, likely as a result of inadvertent gluten exposure
- Are willing to undergo two upper endoscopy procedures
- Are willing to answer symptom questions on a daily basis using your phone
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via e-mail, please include the title of the study in your message.