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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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.
  • - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06001177
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Study Director
Principal Investigator Affiliation Anokion SA
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease, Coeliac Disease
Additional Details

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.

Arms & Interventions

Arms

Experimental: Group 1

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

Placebo Comparator: Group 2

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

Interventions

Drug: - KAN-101

Dose KAN-101 Intravenous (IV) Infusion

Drug: - Placebo

Placebo Intravenous (IV) Infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Peak Gastroenterology Associates, Colorado Springs, Colorado

Status

Recruiting

Address

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907

Site Contact

Study Coordinator

clinicaltrials@anokion.com

719-362-2281

Homestead Associates in Research Inc., Miami, Florida

Status

Recruiting

Address

Homestead Associates in Research Inc.

Miami, Florida, 33032

Site Contact

Study Coordinator

clinicaltrials@anokion.com

305-246-0873

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