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

Celiac Disease Clinical Trial

— SynCeD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001177
• Other study ID #: KAN-101-03
• Status: Recruiting
• Phase: Phase 2
• Start date: December 13, 2023
• Est. completion date: June 2025

Study information

• Verified date: June 2024
• Source: Anokion SA
• Contact: Kanyos Bio, Inc (a wholly owned subsidiary of Anokion SA)
• Phone: +1 857-320-6607
• Email: clinicaltrials[@]anokion.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease
• Coeliac Disease

Intervention

Drug:
• KAN-101
Dose KAN-101 Intravenous (IV) Infusion
• Placebo
Placebo Intravenous (IV) Infusion

Locations

Country	Name	City	State
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
Germany	Studiengesellschaft BSF Unternehmergesellschaft	Halle	Sachsen-Anhalt
Poland	MZ Badania Slowik Zymla Spolka Jawna	Knurów	Slaskie
Poland	Centrum Medyczne Med-Gastr Sp. z o.o.	Lódz	Lódzkie
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	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	Ochsner Clinic Foundation	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA	Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Poland, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in Vh:Cd as assessed by esophagogastroduodenoscopy with biopsy after 2-week gluten challenge (GC)	Vh:Cd is the ratio of villous height to crypt depth, a histological assessment	29 days
Secondary	Change in magnitude of IL-2 response from Day 15 (first day of GC) pre GC to Day 15 post GC	IL-2 is interleukin-2	15 days
Secondary	Changes from baseline in IEL density in duodenum biopsy after 2-week GC	IEL is intraepithelial lymphocyte	29 days
Secondary	Incidence and severity of treatment emergent adverse events as assessed by the CTCAE	Common Terminology Criteria for Adverse Events (CTCAE) is a scale with 5 grades to assess Adverse Event (AE) severity	42 days
Secondary	Incidence of KAN-101 ADA	ADA is antidrug antibody	42 days
Secondary	Titer of KAN-101 ADA	ADA is antidrug antibody	42 days
Secondary	KAN-101 plasma concentration: AUCinf	Pharmacokinetic (PK) sample collection at pre and post dose timepoints	7 days
Secondary	KAN-101 plasma concentration: AUClast	PK sample collection at pre and post dose timepoints	7 days
Secondary	KAN-101 plasma concentration: Cmax	PK sample collection at pre and post dose timepoints	7 days
Secondary	KAN-101 plasma concentration: Tmax	PK sample collection at pre and post dose timepoints	7 days
Secondary	KAN-101 plasma concentration: T1/2	PK sample collection at pre and post dose timepoints	7 days