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

A Randomized, Double-Blind, Placebo-Controlled, Phase II Study Testing CCX282-B in the Treatment of Celiac Disease

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

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

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