Back to resultsA Phase II Study of CCX282-B in Patients With Celiac Disease
Primary Purpose
Celiac Disease
Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
CCX282-B
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Celiac Disease
Eligibility 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
Sites / Locations
- Finn-Medi Research Ltd, Outpatient Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00540657
Brief Title
A Phase II Study of CCX282-B in Patients With Celiac Disease
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Phase II Study Testing CCX282-B in the Treatment of Celiac Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
ChemoCentryx
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CCX282-B
Intervention Description
250mg capsule, twice daily, 13 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule, twice daily, 13 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Evaluation of CCX282-B compared to placebo on small intestinal mucosal inflammation before and after gluten exposure
Title
Evaluation of CCX282-B compared to placebo on gluten-induced celiac-type serology before and after gluten exposure
Title
Evaluation of CCX282-B compared to placebo on symptom scores before and after gluten exposure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Finn-Medi Research Ltd, Outpatient Clinic
City
Tampere
ZIP/Postal Code
FIN-33520
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
A Phase II Study of CCX282-B in Patients With Celiac Disease
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