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

CL009_282

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

2007-10-01

2008-06-01

2008-07-01

Completed

Early phase I

90

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

2023-08-25