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Completed

NCT Number: NCT06001177

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

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

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Key information

Conditions

Celiac Disease Coeliac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

McMaster University, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KAN-101

Drug

Dose KAN-101 Intravenous (IV) Infusion

Other names: Group 1, Treatment Arm

Placebo

Drug

Placebo Intravenous (IV) Infusion

Other names: Group 2, Placebo Comparator Arm

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Changes From Baseline in Intraepithelial Lymphocyte (IEL) Density in Duodenum Biopsy After 2-week GC

    Time frame: Baseline and Day 29

  3. 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).

  4. Incidence by Visit of KAN-101 Antidrug Antibody (ADA)

    Time frame: Up to 42 days

  5. 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.

  6. 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).

  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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • Pfizer

Registry information

Official study title

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

Acronym: SynCeD

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2023
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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