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

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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