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

NCT06001177 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: KAN-101-03
• Study Type: interventional
• Target: 55
• Locations: 8 countries
• Sites: 28

Brief Summary

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

Conditions

Celiac Disease; Coeliac Disease

Keywords

celiac disease; HLA-DQ2.5; gluten free diet

Outcome Measures

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)

  KAN-101 attenuated GC-induced changes in duodenal histology as measured by the Vh:Cd ratio.

  Baseline and Day 29

Secondary Outcomes (9)

• 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)

  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

  0 minutes, 30 minutes, 2 hours 30 minutes, 4 hours post dose on day 1 and day 7

Study Arms (2)

Group 1

EXPERIMENTAL

All eligible participants will receive 3 intravenous (IV) infusions of KAN-101

Drug: KAN-101

Group 2

PLACEBO COMPARATOR

All eligible participants will receive 3 intravenous (IV) infusions of placebo

Drug: Placebo

Interventions

KAN-101 DRUG

Dose KAN-101 Intravenous (IV) Infusion

Also known as: Group 1, Treatment Arm

Group 1

Placebo DRUG

Placebo Intravenous (IV) Infusion

Also known as: Group 2, Placebo Comparator Arm

Group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Refractory celiac disease
• HLA-DQ8 genotype
• Selective IgA deficiency
• Diagnosis of type-I diabetes
• Other Active gastrointestinal diseases
• History of dermatitis herpetiformis

Sponsors & Collaborators

• Pfizer: collaborator
• Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA: lead

Study Sites (28)

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907, United States

Location

Unlimited Medical Research Group

Hialeah Gardens, Florida, 33018, United States

Location

Homestead Associates in Research Inc.

Miami, Florida, 33032, United States

Location

Alliance for Multispecialty Research, LLC

Wichita, Kansas, 67207, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

LHSC

London, Ontario, N6A 5W9, Canada

Location

Centre Intégré de Santé et de Services Sociaux-Chaudière Appalaches - Hôtel-Dieu de Lévis

Lévis, Quebec, G6V 3Z1, Canada

Location

Hopital Du Sacre-Coeur De Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Diex Recherche Quebec Inc.

Québec, Quebec, G1V 4T3, Canada

Location

Tays Research Services

Tampere, Pirkanmaa, 33520, Finland

Location

Clinical Research Services Turku

Turku, Southwest Finland, 20520, Finland

Location

CRST Helsinki Oy

Helsinki, Uusimaa, 00180, Finland

Location

Studiengesellschaft BSF Unternehmergesellschaft

Halle, Saxony-Anhalt, 6108, Germany

Location

Connolly Hospital

Dublin, Dublin, D15X40D, Ireland

Location

Our Lady of Lourdes Hospital

Drogheda, Louth, A92VW28, Ireland

Location

Midland Regional Hospital Mullingar

Mullingar, Westmeath, N91Na43, Ireland

Location

Rabin Medical Center

Petah Tikva, Central District, 4941492, Israel

Location

Sheba Medical Center

Ramat Gan, Central District, 5265601, Israel

Location

Shaare Zedek Medical Center

Jerusalem, Jerusalem, 9103102, Israel

Location

Soroka Medical Center

Beersheba, Southern District, 8410101, Israel

Location

Albert Schweitzer Ziekenhuis, locatie Dordwijk

Dordrecht, South Holland, 3318AT, Netherlands

Location

Gastromed Sp. z o. o.

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

Location

Melita Medical

Wroclaw, Lower Silesian Voivodeship, 50-449, Poland

Location

WIP Warsaw IBD Point Profesor Kierkuś

Warsaw, Masovian Voivodeship, 00-728, Poland

Location

MZ Badania Slowik Zymla Spolka Jawna

Knurów, Silesian Voivodeship, 44-190, Poland

Location

Centrum Medyczne Med-Gastr Sp. z o.o.

Lodz, Łódź Voivodeship, 91-034, Poland

Location

Related Publications (1)

• 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.

  PMID: 37329900 BACKGROUND

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Study Director
• Organization: Kanyos Bio, Inc.

clinicaltrials@anokion.com

+1-857-320-6607

Study Officials

• Study Director

  Anokion SA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study participants and their caregivers, investigators and other staff, and sponsor staff involved in the study team will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a randomized, double-blind, placebo-controlled study with approximately 52 participants that will receive KAN-101 or placebo

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 21, 2023
• Study Start: December 13, 2023
• Primary Completion: January 3, 2025
• Study Completion: January 13, 2025
• Last Updated: December 18, 2025
• Results First Posted: December 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (4); FI (3); US (6); PL (5); IE (3); CA (5); DE (1); NL (1)