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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014