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

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Status and phase: Enrolling; Phase 2

Conditions: Coeliac Disease; Celiac Disease

Treatments: Drug: KAN-101; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06001177

KAN-101-03

Details and patient eligibility

About

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

Full description

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 2 patient groups, including a placebo group

Group 1

Experimental group

Description:

All eligible participants will receive 3 intravenous (IV) infusions of KAN-101

Treatment:

Drug: KAN-101

Group 2

Placebo Comparator group

Description:

All eligible participants will receive 3 intravenous (IV) infusions of placebo

Treatment:

Drug: Placebo