Celiac Disease MedDRA version: 9.1 Level: LLT Classification code 10007864 Term: Celiac disease
Conditions
Interventions
Product Name: Traficet-EN
Product Code: CCX282-B
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Sponsors
ChemoCentryx, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female subjects, from18 to 75 years old, who have a prior diagnosis of celiac disease and who have been following a gluten-free diet for at least 24 months prior to study entry. Subjects must be anti-tissue transglutaminase antibody negative tested using the rapid point-of-care fingertip whole blood test (Biocard Celiac-Test, ANIBiotech, Vantaa, Finland) at study entry. If a female of childbearing potential, or if a male whose partner is a woman of childbearing potential, the subject must agree to use adequate contraception during the 91 days of administration of study medication. The subject must be willing and able to give written Informed Consent and comply with the requirements of the study protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •The subject is pregnant, trying to become pregnant, or breast feeding. •The subject has a known sensitivity to any of the components of the CCX282-B formulation (microcrystalline cellulose, polyvinyl pyrrolidone, sodium lauryl sulphate, colloidal silicon dioxide, crospovidone, or sodium stearyl fumarate). •Use of any immunosuppressants during the 12 weeks prior to study entry and use of steroids during the 4 weeks prior to randomization (Visit 2). TNF inhibitor or natalizumab use during the 12 weeks prior to randomization. •History or presence of illicit drug use and/or alcohol abuse within the year prior to study entry. •History or presence of any medical or psychiatric condition or disease, or laboratory abnormality that, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation and completion. •Active tuberculosis •History of any form of cancer within five years prior to study entry, with the exception of basal cell or squamous cell skin cancer, cervical carcinoma in situ, or breast carcinoma in situ that has been excised or resected completely and is without evidence of recurrence or metastasis. •The subject has a history of infection requiring intravenous antibiotics, a serious local infection (eg, cellulitis or abscess), systemic infection (eg, pneumonia, septicemia), or gastrointestinal infection within 12 weeks of randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the effect of CCX282-B compared to placebo on the small intestinal mucosal morphology (measured as villous height/crypt depth ratio) of biopsy specimens taken from subjects with celiac disease on a longstanding gluten-free diet, before and after gluten exposure.;Secondary Objective: Secondary objectives of this study include evaluation of CCX282-B compared to placebo on: small intestinal mucosal inflammation; gluten-induced celiac-type serology; symptom scores; malabsorption parameters, and safety and tolerability profiles. Further exploratory outcomes will be investigated. These will include evaluation of CCX282-B compared to placebo on mucosal IgA deposit densities , CCR9 expression and HRA DR staining. ;Primary end point(s): The primary efficacy endpoint is the measurement of villous-height to crypt-depth ratio at baseline and at time of repeat oespohago-gastro-duodenoscopy (Study Day 91). It is hypothesized that the active drug, CCX282-B, prevents the gluten-induced mucosal deterioration. | — |
Countries
Finland
Outcome results
None listed