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

October 5, 2007
July 21, 2008
October 2007
June 2008   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00540657 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 gluten-induced celiac-type serology before and after gluten exposure
  • Evaluation of CCX282-B compared to placebo on symptom scores before and after gluten exposure
Not Provided
Not Provided
 
A Phase II Study of CCX282-B in Patients With Celiac Disease
A Randomized, Double-Blind, Placebo-Controlled, Phase II Study Testing CCX282-B in the Treatment of Celiac Disease

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Celiac Disease
  • Drug: CCX282-B
    250mg capsule, twice daily, 13 weeks
  • Drug: Placebo
    Placebo capsule, twice daily, 13 weeks
  • Experimental: 1
    Intervention: Drug: CCX282-B
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
July 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00540657
CL009_282
No
Dr. Pirow Bekker, ChemoCentryx
ChemoCentryx
Not Provided
Principal Investigator: Markku Mäki, MD PhD University of Tampere
Study Director: Gordon Hamilton, MD ChemoCentryx
ChemoCentryx
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP