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

Celiac Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00540657
• Other study ID #: CL009_282
• Status: Completed
• Phase: Phase 2
• Start date: October 2007
• Est. completion date: July 2008

Study information

• Verified date: August 2023
• Source: ChemoCentryx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Drug:
• CCX282-B
250mg capsule, twice daily, 13 weeks
• Placebo
Placebo capsule, twice daily, 13 weeks

Locations

Country	Name	City	State
Finland	Finn-Medi Research Ltd, Outpatient Clinic	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
ChemoCentryx

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of CCX282-B compared to placebo on small intestinal mucosal inflammation before and after gluten exposure
Secondary	Evaluation of CCX282-B compared to placebo on gluten-induced celiac-type serology before and after gluten exposure
Secondary	Evaluation of CCX282-B compared to placebo on symptom scores before and after gluten exposure