Assessment of KAN-101 in Celiac Disease (ACeD)
Celiac Disease
About this trial
This is an interventional treatment trial for Celiac Disease focused on measuring Phase 1, Double blind, Multicenter
Eligibility Criteria
Key Inclusion Criteria:
- Adults aged 18 to 70 years inclusive
- Diagnosed with celiac disease based on positive serology (eg, tissue transglutaminase IgA antibody and/or deamidated gliadin peptide IgG) and intestinal histology consistent with ≥ Marsh Type II or with evidence of villous atrophy
- Has HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygotes or heterozygotes)
- Has followed a GFD for > 12 months immediately prior to study entry
- Negative or weak positive for tTG-IgA and negative or weak positive for DGP-IgA/IgG during screening
- Male or female. Females of childbearing potential must use at least 2 acceptable birth control methods
- Capable of understanding and complying with protocol requirements
- Patient understands and has signed the informed consent form
Key Exclusion Criteria:
- Refractory celiac disease
- Selective IgA deficiency
- Positive for HLA-DQ8 (DQA1*03, DQB1*0302)
- Previous treatment with tolerance-inducing therapies for celiac disease
- Known wheat allergy
- Part B only: History of hyperacute or prolonged symptoms following gluten exposure
- Uncontrolled or significant medical conditions (including active infections or chronic hepatitis) which, in the opinion of the Investigator, preclude participation
- History of dermatitis herpetiformis
- Pregnant or breastfeeding
Sites / Locations
- Anaheim Clinical Trials
- Diablo Clinical Research
- GCP Research
- Tandem Clinical Research
- Parexel International- EPCU Baltimore
- West Michigan Clinical Research Center
- Mayo Clinic
- Celiac Disease Center at Columbia University
- North Carolina Clinical Research
- Aventiv Research
- Advanced Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
SAD Cohort 1
SAD Cohort 2
SAD Cohort 3
SAD Cohort 4
MAD Cohort 5
MAD Cohort 6
MAD Cohort 7
All enrolled patients will receive one dose of KAN-101 Dose A
All enrolled patients will receive one dose of KAN-101 Dose B
All enrolled patients will receive one dose of KAN-101 Dose C
All enrolled patients will receive one dose of KAN-101 Dose D
All randomized patients will receive 3 doses of either KAN-101 Dose A or placebo
All randomized patients will receive 3 doses of either KAN-101 Dose B or placebo
All randomized patients will receive 3 doses of either KAN-101 Dose C or placebo