A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)
Reason given: Sponsor decision
Key facts
- Where
- Anaheim, Birmingham, Chicago, Columbus, Hershey, Houston, Indianapolis, Iowa City, Mentor, Nashville, New York, Normal, Ogden, Omaha, Raleigh, Rochester, Saint Paul, Sandy Springs, St Louis, St. Petersburg, Waco, West Jordan, and Westlake, United StatesSee the 23 sites
- Phase
- Phase 1/2
Where in United States
- Anaheim Clinical Trials, LLCAnaheim, United StatesNo longer taking part
- University of Alabama at BirminghamBirmingham, United StatesNo longer taking part
- Rush University Medical CenterChicago, United StatesNo longer taking part
- Aventiv Research, Inc. d/b/a Centricity ResearchColumbus, United StatesNo longer taking part
- Penn State Milton S. Hershey Medical CenterHershey, United StatesNo longer taking part
- The University of Texas Health Science Center at HoustonHouston, United StatesNo longer taking part
- Indiana University Health University HospitalIndianapolis, United StatesNo longer taking part
- University of IowaIowa City, United StatesNo longer taking part
- Great Lakes Gastroenterology Research, LLCMentor, United StatesNo longer taking part
- Vanderbilt University Medical CenterNashville, United StatesNo longer taking part
- Celiac Disease Center at Columbia UniversityNew York, United StatesNo longer taking part
- Sneeze, Wheeze, & Itch Associates LLCNormal, United StatesNo longer taking part
- Advanced Research InstituteOgden, United StatesNo longer taking part
- Quality Clinical ResearchOmaha, United StatesNo longer taking part
- North Carolina Clinical ResearchRaleigh, United StatesNo longer taking part
- Mayo ClinicRochester, United StatesNo longer taking part
- Prism Research LLC dba Nucleus NetworkSaint Paul, United StatesNo longer taking part
- Agile Clinical Research TrialsSandy Springs, United StatesNo longer taking part
- Washington University School of MedicineSt Louis, United StatesNo longer taking part
- GCP ResearchSt. Petersburg, United StatesNo longer taking part
- Digestive Research of Central TexasWaco, United StatesNo longer taking part
- Velocity Clinical Research, Salt Lake CityWest Jordan, United StatesNo longer taking part
- Northshore Gastroenterology Research, LLCWestlake, United StatesNo longer taking part
Trial details
- Who runs it
- Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
- Trial code
- NCT05574010
- Record updated
- 10 March 2026
- Original description
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).Read full original descriptionShow less
A Phase 1B Open-label/Phase 2 Double-blind Placebo- Controlled Study for Pharmacodynamic (PD) Activity, Pharmacokinetics (PK), Safety, and Tolerability of KAN-101 In Patients With Celiac Disease (CeD)
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).
Inclusion: 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.
Exclusion: Previous oral gluten challenge within 12 months; Refractory celiac disease; Diagnosis of Type-1 diabetes; Active gastrointestinal diseases; History of dermatitis herpetiformis; HLA-DQ8 genotype; Selective IgA deficiency.