Overview
The study is a 3-part, multicenter Phase 1b/2 study of KAN-101 in participants with Celiac Disease (CeD) on a gluten free diet (GFD). The 3 parts include: - Part A - Open-label, multiple ascending dose - Part B - Double-blind, placebo-controlled, parallel design - Part C - Double-blind, placebo-controlled, parallel design Part A is a Phase 1b, open-label, multiple ascending dose (MAD) study design to assess the safety, tolerability, and pharmacokinetics (PK) of KAN-101 in adult participants (18 to 70 years inclusive) with histology-confirmed CeD. Up to 12 participants who meet study inclusion/exclusion criteria will receive 1 of 2 dose levels of KAN-101. The overall study duration will be about 56 days, including up to 28 days of screening, 7 days of treatment and 21 days of follow up. There will be a gluten challenge test (GC) on Day 15. Parts B and C are Phase 2, double-blind, placebo-controlled, parallel design study to characterize the biomarker response following GC, safety, tolerability, and PK of KAN-101 in adult participants with histology-confirmed CeD. Approximately 16 participants (4 participants per dose group) will be enrolled in Part B and 104 participants (26 participants per dose group) enrolled into Part C. Participants will be randomized 1:1:1:1 and stratified by participation in a biopsy substudy to 4 treatment groups: placebo and 3 treatment groups with KAN-101 doses based on information obtained from Part A.
Principal investigator
Eligibility criteria
Inclusion Criteria:
- Previous diagnosis of celiac disease based on histology and positive celiac serology
- HLA-DQ2.5 genotype
- Gluten-free diet for at least 12 months
- Negative or weak positive for transglutaminase IgA and negative or weak positive for DGP-IgA/IgG during screening
Exclusion Criteria:
- Refractory celiac disease
- HLA-DQ8 genotype
- Previous oral gluten challenge within 12 months
- Selective IgA deficiency
- Diagnosis of Type-1 diabetes
- Active gastrointestinal diseases
- History of dermatitis herpetiformis
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