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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00540657
Recruitment Status : Completed
First Posted : October 8, 2007
Last Update Posted : July 22, 2008
Sponsor:
Information provided by:

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
Celiac Disease Drug: CCX282-B Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2007
Primary Completion Date : June 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Evaluation of CCX282-B compared to placebo on small intestinal mucosal inflammation before and after gluten exposure
  2. Evaluation of CCX282-B compared to placebo on gluten-induced celiac-type serology before and after gluten exposure
  3. Evaluation of CCX282-B compared to placebo on symptom scores before and after gluten exposure

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Pirow Bekker, ChemoCentryx
ClinicalTrials.gov Identifier: NCT00540657     History of Changes
Other Study ID Numbers: CL009_282
First Posted: October 8, 2007    Key Record Dates
Last Update Posted: July 22, 2008
Last Verified: July 2008

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