The trial is taking place at:
P

Peak Gastroenterology Associates | Peak Gastro Colorado Springs

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

K

Kanyos Bio

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

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

Trial contacts and locations

7

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Central trial contact

Kanyos Bio, Inc (a wholly owned subsidiary of Anokion SA)

Data sourced from clinicaltrials.gov

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