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

December 2, 2025 updated by: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA

A Phase 2a Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of KAN-101 In Participants With Celiac Disease

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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. Approximately 52 participants who meet study inclusion/exclusion criteria will be randomized 1:1 to receive KAN-101 or placebo.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4L8
        • McMaster University
      • London, Ontario, Canada, N6A 5W9
        • LHSC
    • Quebec
      • Lévis, Quebec, Canada, G6V 3Z1
        • Centre Intégré de Santé et de Services Sociaux-Chaudière Appalaches - Hôtel-Dieu de Lévis
      • Montreal, Quebec, Canada, H4J 1C5
        • Hopital Du Sacre-Coeur de Montreal
      • Québec, Quebec, Canada, G1V 4T3
        • Diex Recherche Quebec Inc.
  • Finland
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Tays Research Services
    • Southwest Finland
      • Turku, Southwest Finland, Finland, 20520
        • Clinical Research Services Turku
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00180
        • CRST Helsinki Oy
  • Germany
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 6108
        • Studiengesellschaft BSF Unternehmergesellschaft
  • Ireland
    • Dublin
      • Dublin, Dublin, Ireland, D15X40D
        • Connolly Hospital
    • Louth
      • Drogheda, Louth, Ireland, A92VW28
        • Our Lady of Lourdes Hospital
    • Westmeath
      • Mullingar, Westmeath, Ireland, N91Na43
        • Midland Regional Hospital Mullingar
  • Israel
    • Central District
      • Petah Tikva, Central District, Israel, 4941492
        • Rabin Medical Center
      • Ramat Gan, Central District, Israel, 5265601
        • Sheba Medical Center
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
    • Southern District
      • Beersheba, Southern District, Israel, 8410101
        • Soroka Medical Center
  • Netherlands
    • South Holland
      • Dordrecht, South Holland, Netherlands, 3318AT
        • Albert Schweitzer Ziekenhuis, locatie Dordwijk
  • Poland
    • Kuyavian-Pomeranian Voivodeship
      • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
        • Gastromed Sp. z o. o.
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-449
        • Melita Medical
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 00-728
        • WIP Warsaw IBD Point Profesor Kierkus
    • Silesian Voivodeship
      • Knurów, Silesian Voivodeship, Poland, 44-190
        • MZ Badania Slowik Zymla Spolka jawna
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 91-034
        • Centrum Medyczne Med-Gastr Sp. z o.o.
  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Peak Gastroenterology Associates
    • Florida
      • Hialeah Gardens, Florida, United States, 33018
        • Unlimited Medical Research Group
      • Miami, Florida, United States, 33032
        • Homestead Associates in Research Inc.
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Alliance for Multispecialty Research, LLC
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
All eligible participants will receive 3 intravenous (IV) infusions of KAN-101
Drug: KAN-101
Dose KAN-101 Intravenous (IV) Infusion
Other Names:
  • Group 1, Treatment Arm
Placebo Comparator: Group 2
All eligible participants will receive 3 intravenous (IV) infusions of placebo
Drug: Placebo
Placebo Intravenous (IV) Infusion
Other Names:
  • Group 2, Placebo Comparator Arm

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes From Baseline in Villous Height to Crypt Depth (Vh:Cd) as Assessed by Esophagogastroduodenoscopy With Biopsy After 2-week Gluten Challenge (GC)
Time Frame: Baseline and Day 29
KAN-101 attenuated GC-induced changes in duodenal histology as measured by the Vh:Cd ratio.
Baseline and Day 29

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Magnitude of Interleukin-2 (IL-2) Response From Day 15 (First Day of GC) Pre-GC to Day 15 Post GC
Time Frame: From Day 15 pre-GC to Day 15 post GC
From Day 15 pre-GC to Day 15 post GC
Changes From Baseline in Intraepithelial Lymphocyte (IEL) Density in Duodenum Biopsy After 2-week GC
Time Frame: Baseline and Day 29
Baseline and Day 29
Incidence and Severity of Treatment Emergent Adverse Events (TEAE) as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
Time Frame: From the time the participant provided informed consent through Day 42.
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious adverse events. SAE was defined as any untoward medical occurrence that, at any dose resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. According to NCI CTCAE version 5: Grade 1= mild AE; Grade 2= moderate AE; Grade 3=severe AE; Grade 4= life-threatening consequences and urgent intervention indicated; Grade 5= death related to AE. An AE was considered treatment-emergent relative to a given treatment if the event start date is during the on-treatment period (including on the date of first dose).
From the time the participant provided informed consent through Day 42.
Incidence by Visit of KAN-101 Antidrug Antibody (ADA)
Time Frame: Up to 42 days
Up to 42 days
KAN-101 Plasma Concentration: AUCinf
Time Frame: 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7
Area under the plasma-concentration time curve from time 0 extrapolated to infinite time.
0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7
KAN-101 Plasma Concentration: AUClast
Time Frame: 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7
Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast).
0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7
KAN-101 Plasma Concentration: Cmax
Time Frame: 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7
Maximum plasma concentration.
0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7
KAN-101 Plasma Concentration: Tmax
Time Frame: 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7
Time to reach Cmax.
0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7
KAN-101 Plasma Concentration: T1/2
Time Frame: 0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7
Terminal phase half-life.
0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, Anokion SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 13, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 3, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 13, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KAN-101-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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