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

Phase 2

Completed

• Conditions: Celiac Disease
• Interventions: Drug: CCX282-B; Drug: Placebo

• Registration Number: NCT00540657
• Lead Sponsor: Amgen

Brief 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

Detailed Description

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

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-05
• Study First Posted: 2007-10-08
• Primary Completion: 2008-06
• Study Completion: 2008-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CCX282-B	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Evaluation of the effect of CCX282-B compared to placebo on the villous height/crypt depth ratio of small intestinal biopsy specimens taken from subjects with celiac disease, before and after gluten exposure.

Secondary Outcome Measures

Name	Time	Method
Evaluation of CCX282-B compared to placebo on gluten-induced celiac-type serology before and after gluten exposure
Evaluation of CCX282-B compared to placebo on small intestinal mucosal inflammation before and after gluten exposure
Evaluation of CCX282-B compared to placebo on symptom scores before and after gluten exposure

Trial Locations

Locations (1)

Finn-Medi Research Ltd, Outpatient Clinic; 🇫🇮 Tampere, Finland