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

Phase 2

Completed

• Conditions: Celiac Disease; Coeliac Disease
• Interventions: Drug: KAN-101; Drug: Placebo

• Registration Number: NCT06001177
• Lead Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-08-07
• Study First Submitted QC: 2023-08-14
• Study First Posted: 2023-08-21
• Study Start: 2023-12-13
• Primary Completion: 2025-01-03
• Study Completion: 2025-01-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	KAN-101	All eligible participants will receive 3 intravenous (IV) infusions of KAN-101
Group 2	Placebo	All eligible participants will receive 3 intravenous (IV) infusions of placebo

Primary Outcome Measures

Name	Time	Method
Changes from baseline in Vh:Cd as assessed by esophagogastroduodenoscopy with biopsy after 2-week gluten challenge (GC)	29 days	Vh:Cd is the ratio of villous height to crypt depth, a histological assessment

Secondary Outcome Measures

Name	Time	Method
Change in magnitude of IL-2 response from Day 15 (first day of GC) pre GC to Day 15 post GC	15 days	IL-2 is interleukin-2
Incidence and severity of treatment emergent adverse events as assessed by the CTCAE	42 days	Common Terminology Criteria for Adverse Events (CTCAE) is a scale with 5 grades to assess Adverse Event (AE) severity
Incidence of KAN-101 ADA	42 days	ADA is antidrug antibody
Titer of KAN-101 ADA	42 days	ADA is antidrug antibody
KAN-101 plasma concentration: AUCinf	7 days	Pharmacokinetic (PK) sample collection at pre and post dose timepoints
KAN-101 plasma concentration: AUClast	7 days	PK sample collection at pre and post dose timepoints
KAN-101 plasma concentration: Cmax	7 days	PK sample collection at pre and post dose timepoints
KAN-101 plasma concentration: Tmax	7 days	PK sample collection at pre and post dose timepoints
KAN-101 plasma concentration: T1/2	7 days	PK sample collection at pre and post dose timepoints
Changes from baseline in IEL density in duodenum biopsy after 2-week GC	29 days	IEL is intraepithelial lymphocyte

Trial Locations

Locations (28)

Peak Gastroenterology Associates; 🇺🇸 Colorado Springs, Colorado, United States

Unlimited Medical Research Group; 🇺🇸 Hialeah Gardens, Florida, United States

Homestead Associates in Research Inc.; 🇺🇸 Miami, Florida, United States

Alliance for Multispecialty Research, LLC; 🇺🇸 Wichita, Kansas, United States

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

McMaster University; 🇨🇦 Hamilton, Ontario, Canada

LHSC; 🇨🇦 London, Ontario, Canada

Centre Intégré de Santé et de Services Sociaux-Chaudière Appalaches - Hôtel-Dieu de Lévis; 🇨🇦 Lévis, Quebec, Canada

Hopital Du Sacre-Coeur De Montreal; 🇨🇦 Montréal, Quebec, Canada

Diex Recherche Quebec Inc.; 🇨🇦 Québec, Quebec, Canada

Tays Research Services; 🇫🇮 Tampere, Pirkanmaa, Finland

CRST Helsinki Oy; 🇫🇮 Helsinki, Uusimaa, Finland

Clinical Research Services Turku; 🇫🇮 Turku, Varsinais-Suomi, Finland

Studiengesellschaft BSF Unternehmergesellschaft; 🇩🇪 Halle, Sachsen-Anhalt, Germany

Our Lady of Lourdes Hospital; 🇮🇪 Drogheda, Louth, Ireland

Midland Regional Hospital Mullingar; 🇮🇪 Mullingar, Westmeath, Ireland

Connolly Hospital; 🇮🇪 Dublin, Ireland

Soroka Medical Center; 🇮🇱 Be'er Sheva, Hadarom, Israel

Rabin Medical Center; 🇮🇱 Petah tikva, Hamerkaz, Israel

Sheba Medical Center; 🇮🇱 Ramat Gan, Hamerkaz, Israel

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Yerushalayim, Israel

Albert Schweitzer Ziekenhuis, locatie Dordwijk; 🇳🇱 Dordrecht, Zuid-Holland, Netherlands

Melita Medical; 🇵🇱 Wrocław, Dolnośląskie, Poland

Gastromed Sp. z o. o.; 🇵🇱 Toruń, Kujawsko-pomorskie, Poland

WIP Warsaw IBD Point Profesor Kierkuś; 🇵🇱 Warszawa, Mazowieckie, Poland

Centrum Medyczne Med-Gastr Sp. z o.o.; 🇵🇱 Łódź, Łódzkie, Poland

MZ Badania Slowik Zymla Spolka Jawna; 🇵🇱 Knurów, Śląskie, Poland