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

Amgen

Status and phase: Completed; Phase 2

Conditions: Celiac Disease

Treatments: Drug: Placebo; Drug: CCX282-B

Study type: Interventional

Funder types: Industry

Identifiers

NCT00540657

CL009_282

Details and patient eligibility

About

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

Full description

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

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: CCX282-B

2

Placebo Comparator group

Treatment:

Drug: Placebo