NCT06001177

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Celiac Disease
• Coeliac Disease

Interventions

Type	Name	Description
DRUG	KAN-101	Dose KAN-101 Intravenous (IV) Infusion
DRUG	Placebo	Placebo Intravenous (IV) Infusion

Timeline

• Start date: 2023-12-13
• Primary completion: 2025-01-03
• Completion: 2025-01-13
• First posted: 2023-08-21
• Last updated: 2025-12-18
• Results posted: 2025-12-18

Locations

28 sites across 8 countries: United States, Canada, Finland, Germany, Ireland, Israel, Netherlands, Poland

Regulatory

• FDA-regulated drug study