A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Celiac Disease

In brief

This study is to evaluate the Pharmacodynamic (PD), safety, tolerability, Pharmacokinetic (PK), and plasma biomarker response of KAN-101 in participants with Celiac Disease (CeD).

Key facts

Study ID

NCT05574010

Run by

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

People needed

128

Starts

2022-11-15

Expected to finish

2025-05-19

Last updated by the study team

2026-03-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Refractory celiac disease
• HLA-DQ8 genotype
• Previous oral gluten challenge within 12 months
• Selective IgA deficiency
• Diagnosis of Type-1 diabetes
• Active gastrointestinal diseases
• History of dermatitis herpetiformis

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• GCP Research — St. Petersburg, Florida, United States
• Agile Clinical Research Trials — Sandy Springs, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Sneeze, Wheeze & Itch Associates, LLC — Normal, Illinois, United States
• Indiana University Health University Hospital — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Prism Research LLC dba Nucleus Network — Saint Paul, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Quality Clinical Research — Omaha, Nebraska, United States
• Celiac Disease Center at Columbia University — New York, New York, United States
• North Carolina Clinical Research — Raleigh, North Carolina, United States
• Aventiv Research, Inc. d/b/a Centricity Research — Columbus, Ohio, United States
• Great Lakes Gastroenterology Research, LLC — Mentor, Ohio, United States
• Northshore Gastroenterology Research, LLC — Westlake, Ohio, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• The University of Texas Health Science Center at Houston — Houston, Texas, United States
• Digestive Research of Central Texas — Waco, Texas, United States
• Advanced Research Institute — Ogden, Utah, United States
• Velocity Clinical Research, Salt Lake City — West Jordan, Utah, United States
• Campbelltown Hospital — Campbelltown, New South Wales, Australia
• Wesley Research Institute — Auchenflower, Queensland, Australia

Full record on ClinicalTrials.gov

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