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

Sponsored by:	ChemoCentryx
Information provided by:	ChemoCentryx
ClinicalTrials.gov Identifier:	NCT00540657

Purpose

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

Condition	Intervention	Phase
Celiac Disease	Drug: CCX282-B Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Phase II Study Testing CCX282-B in the Treatment of Celiac Disease

Resource links provided by NLM:

MedlinePlus related topics: Celiac Disease

Further study details as provided by ChemoCentryx:

Primary Outcome Measures:

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. [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluation of CCX282-B compared to placebo on small intestinal mucosal inflammation before and after gluten exposure [ Designated as safety issue: No ]
Evaluation of CCX282-B compared to placebo on gluten-induced celiac-type serology before and after gluten exposure [ Designated as safety issue: No ]
Evaluation of CCX282-B compared to placebo on symptom scores before and after gluten exposure [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	October 2007
Study Completion Date:	July 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: CCX282-B 250mg capsule, twice daily, 13 weeks
2: Placebo Comparator	Drug: Placebo Placebo capsule, twice daily, 13 weeks

Eligibility

Criteria

Key Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540657

Locations

Finland
Finn-Medi Research Ltd, Outpatient Clinic
Tampere, Finland, FIN-33520

Sponsors and Collaborators

ChemoCentryx

Investigators

Principal Investigator:	Markku Mäki, MD PhD	University of Tampere
Study Director:	Gordon Hamilton, MD	ChemoCentryx

More Information

No publications provided

Responsible Party:	ChemoCentryx ( Dr. Pirow Bekker )
Study ID Numbers:	CL009_282
Study First Received:	October 5, 2007
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00540657 History of Changes
Health Authority:	Finland: National Agency for Medicines

Study placed in the following topic categories:

Metabolic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Malabsorption Syndromes

Celiac Disease
Intestinal Diseases
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Digestive System Diseases
Gastrointestinal Diseases

Malabsorption Syndromes
Celiac Disease
Intestinal Diseases

ClinicalTrials.gov processed this record on August 28, 2009