Overview

A Phase II Study of CCX282-B in Patients With Celiac Disease

Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether CCX282-B is effective in mitigating the effects of gluten ingestion in patients with celiac disease
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ChemoCentryx
Criteria
Key Inclusion Criteria:

- Male or female, between 18 and 75 years of age

- Established diagnosis of celiac disease

- Subject has been following a strict gluten-free diet for at least 24 months

Key Exclusion Criteria:

- History of any infection requiring intravenous antibiotics, a serious local infection,
systemic infection, or gastrointestinal infection within 12 weeks of randomization

- Use of any immunosuppressants, TNF inhibitors, or natalizumab during the 12 weeks
prior to study randomization

- Use of steroids during the 4 weeks prior to study randomization

- Receipt of an experimental treatment for any disease within 4 weeks prior to
randomization

- Known IgE-mediated atopy or allergy or anaphylactic reactions to gluten

- The subject suffers from a condition that carries a risk at endoscopy or is on
anticoagulant treatment