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New drug aims to tame gluten reaction in celiac disease

NCT ID NCT05574010

Disease control Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental drug called KAN-101 in people with celiac disease. The goal was to see if it could safely reduce the immune response to gluten. The trial included 128 participants and was split into phases to check safety and how the body processes the drug. However, the study was terminated early, so final conclusions are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KAN-101
What this could lead to
If successful, KAN-101 could offer a new way to manage celiac disease by reducing the immune reaction to gluten.
What could go wrong
This trial was terminated early, so results are limited. It is still in early phases, and it is unknown if it will work for most patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

128 people

The number who actually took part.

Started

Nov 2022

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

celiac disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Celiac disease

Contacts and locations

Locations

  • Advanced Research Institute

    Ogden, Utah, 84405, United States

  • Agile Clinical Research Trials

    Sandy Springs, Georgia, 30328, United States

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801, United States

  • Aventiv Research, Inc. d/b/a Centricity Research

    Columbus, Ohio, 43213, United States

  • Box Hill Hospital

    Box Hill, Victoria, 3128, Australia

  • Campbelltown Hospital

    Campbelltown, New South Wales, 2560, Australia

  • Celiac Disease Center at Columbia University

    New York, New York, 10032, United States

  • Digestive Research of Central Texas

    Waco, Texas, 76712, United States

  • GCP Research

    St. Petersburg, Florida, 33705, United States

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio, 44060, United States

  • Indiana University Health University Hospital

    Indianapolis, Indiana, 46202, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • North Carolina Clinical Research

    Raleigh, North Carolina, 27607, United States

  • Northshore Gastroenterology Research, LLC

    Westlake, Ohio, 44145, United States

  • Optimal Clinical Trials

    Auckland, Auckland, 1023, New Zealand

  • P3 Research - Dunedin

    Dunedin, Otago, 9016, New Zealand

  • P3 Research - Palmerston North

    Paraparaumu, Wellington Region, 5032, New Zealand

  • P3 Research - Tauranga

    Tauranga, Bay of Plenty, 3110, New Zealand

  • P3 Research - Wellington

    Wellington, Wellington Region, 6021, New Zealand

  • PCRN Trials

    Takapuna, Auckland, 0622, New Zealand

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Prism Research LLC dba Nucleus Network

    Saint Paul, Minnesota, 55114, United States

  • Quality Clinical Research

    Omaha, Nebraska, 68114, United States

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Sneeze, Wheeze & Itch Associates, LLC

    Normal, Illinois, 61761, United States

  • St John of God Midland Public and Private Hospitals

    Midland, Western Australia, 6056, Australia

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212, United States

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah, 84088, United States

  • Waikato Hospital

    Hamilton, Hamilton, 3204, New Zealand

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Wesley Research Institute

    Auchenflower, Queensland, 4066, Australia

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Other studies related to the condition(s) this trial covers.