A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease

Study KAN-101-03 is a multi-center, double-blind, placebo-controlled Phase 2a study to examine whether KAN-101 confers protection from gluten exposure induced histological changes in the duodenum and to further evaluate the safety/tolerability of KAN-101 in adult participants (≥18 years) with CeD on a gluten free diet. Approximately 52 participants who meet study inclusion/exclusion criteria will be randomized 1:1 to receive KAN-101 or placebo.

Primary Outcome Measures

1. Changes From Baseline in Villous Height to Crypt Depth (Vh:Cd) as Assessed by Esophagogastroduodenoscopy With Biopsy After 2-week Gluten Challenge (GC)
   KAN-101 attenuated GC-induced changes in duodenal histology as measured by the Vh:Cd ratio.

Secondary Outcome Measures

1. Change in Magnitude of Interleukin-2 (IL-2) Response From Day 15 (First Day of GC) Pre-GC to Day 15 Post GC
2. Changes From Baseline in Intraepithelial Lymphocyte (IEL) Density in Duodenum Biopsy After 2-week GC
3. Incidence and Severity of Treatment Emergent Adverse Events (TEAE) as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
   An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious adverse events. SAE was defined as any untoward medical occurrence that, at any dose resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. According to NCI CTCAE version 5: Grade 1= mild AE; Grade 2= moderate AE; Grade 3=severe AE; Grade 4= life-threatening consequences and urgent intervention indicated; Grade 5= death related to AE. An AE was considered treatment-emergent relative to a given treatment if the event start date is during the on-treatment period (including on the date of first dose).
4. Incidence by Visit of KAN-101 Antidrug Antibody (ADA)
5. KAN-101 Plasma Concentration: AUCinf
   Area under the plasma-concentration time curve from time 0 extrapolated to infinite time.
6. KAN-101 Plasma Concentration: AUClast
   Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast).
7. KAN-101 Plasma Concentration: Cmax
   Maximum plasma concentration.
8. KAN-101 Plasma Concentration: Tmax
   Time to reach Cmax.
9. KAN-101 Plasma Concentration: T1/2
   Terminal phase half-life.