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

Study Overview
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Brief Summary
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The study goal is to evaluate the efficacy, safety, and tolerability of KAN-101 in participants with Celiac Disease (CeD)

Detailed Description
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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. Up to 52 participants who meet study inclusion/exclusion criteria will be randomized 1:1 to receive KAN-101 or placebo.

Official Title
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A Phase 2a Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of KAN-101 In Participants With Celiac Disease

Conditions
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Celiac Disease, Coeliac Disease

Intervention / Treatment
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* Drug: KAN-101
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 Screening intestinal biopsy demonstrating Vh:Cd ratio of 2.3 or higher Exclusion Criteria: Refractory celiac disease HLA-DQ8 genotype Selective IgA deficiency Diagnosis of type-I diabetes Other Active gastrointestinal diseases History of dermatitis herpetiformis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a randomized, double-blind, placebo-controlled study with up to 52 participants that will receive KAN-101 or placebo
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>All eligible participants will receive 3 intravenous (IV) infusions of KAN-101 | Drug: KAN-101<br>* Dose KAN-101 Intravenous (IV) Infusion<br>* Other names: Group 1, Treatment Arm;|
| Placebo Comparator: Group 2<br>All eligible participants will receive 3 intravenous (IV) infusions of placebo | Drug: Placebo<br>* Placebo Intravenous (IV) Infusion<br>* Other names: Group 2, Placebo Comparator Arm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in Vh:Cd as assessed by esophagogastroduodenoscopy with biopsy after 2-week gluten challenge (GC) | Vh:Cd is the ratio of villous height to crypt depth, a histological assessment | 29 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in magnitude of IL-2 response from Day 15 (first day of GC) pre GC to Day 15 post GC | IL-2 is interleukin-2 | 15 days | 
| Changes from baseline in IEL density in duodenum biopsy after 2-week GC | IEL is intraepithelial lymphocyte | 29 days | 
| Incidence and severity of treatment emergent adverse events as assessed by the CTCAE | Common Terminology Criteria for Adverse Events (CTCAE) is a scale with 5 grades to assess Adverse Event (AE) severity | 42 days | 
| Incidence of KAN-101 ADA | ADA is antidrug antibody | 42 days | 
| Titer of KAN-101 ADA | ADA is antidrug antibody | 42 days | 
| KAN-101 plasma concentration: AUCinf | Pharmacokinetic (PK) sample collection at pre and post dose timepoints | 7 days | 
| KAN-101 plasma concentration: AUClast | PK sample collection at pre and post dose timepoints | 7 days | 
| KAN-101 plasma concentration: Cmax | PK sample collection at pre and post dose timepoints | 7 days | 
| KAN-101 plasma concentration: Tmax | PK sample collection at pre and post dose timepoints | 7 days | 
| KAN-101 plasma concentration: T1/2 | PK sample collection at pre and post dose timepoints | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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celiac disease, HLA-DQ2.5, gluten free diet