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

This study has been completed.
Sponsor:
Information provided by:
ChemoCentryx
ClinicalTrials.gov Identifier:
NCT00540657
First received: October 5, 2007
Last updated: July 21, 2008
Last verified: July 2008
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: Dr. Pirow Bekker, ChemoCentryx
ClinicalTrials.gov Identifier: NCT00540657     History of Changes
Other Study ID Numbers: CL009_282
Study First Received: October 5, 2007
Last Updated: July 21, 2008
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on June 17, 2013