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

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: Completed
• Conditions: Celiac Disease; Coeliac Disease
• Intervention / Treatment: Drug: KAN-101; Drug: Placebo

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: Interventional
• Enrollment (Actual): 55
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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)	KAN-101 attenuated GC-induced changes in duodenal histology as measured by the Vh:Cd ratio.	Baseline and Day 29

Secondary Outcome Measures

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		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		Baseline and Day 29
Incidence and Severity of Treatment Emergent Adverse Events (TEAE) as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE)	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)		Up to 42 days
KAN-101 Plasma Concentration: AUCinf	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	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	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 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	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

• Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
• Collaborators: Pfizer
• Investigators: Study Director: Study Director, Anokion SA

Publications and helpful links

General Publications

• Murray JA, Wassaf D, Dunn K, Arora S, Winkle P, Stacey H, Cooper S, Goldstein KE, Manchanda R, Kontos S, Grebe KM. Safety and tolerability of KAN-101, a liver-targeted immune tolerance therapy, in patients with coeliac disease (ACeD): a phase 1 trial. Lancet Gastroenterol Hepatol. 2023 Aug;8(8):735-747. doi: 10.1016/S2468-1253(23)00107-3. Epub 2023 Jun 14.

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2023
• Primary Completion (Actual): January 3, 2025
• Study Completion (Actual): January 13, 2025

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: celiac disease; gluten free diet; HLA-DQ2.5
• Additional Relevant MeSH Terms: Metabolic Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Malabsorption Syndromes; Nutritional and Metabolic Diseases; Celiac Disease
• Other Study ID 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