Phase 2 N=55 Randomized Triple-blind Treatment

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

Celiac Disease · Coeliac Disease

Bottom Line

View on ClinicalTrials.gov: NCT06001177 ↗

Enrolled (actual)

Serious AEs

1.8%

Results posted

Dec 2025

Primary outcome: Primary: Changes From Baseline in Villous Height to Crypt Depth (Vh:Cd) as Assessed by Esophagogastroduodenoscopy With Biopsy After 2-week Gluten Challenge (GC) — -0.85; -0.61 ratio — p=0.1668

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: KAN-101 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
Primary completion: Jan 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes From Baseline in Villous Height to Crypt Depth (Vh:Cd) as Assessed by Esophagogastroduodenoscopy With Biopsy After 2-week Gluten Challenge (GC)	-0.85; -0.61	0.1668
SECONDARY Change in Magnitude of Interleukin-2 (IL-2) Response From Day 15 (First Day of GC) Pre-GC to Day 15 Post GC	31.8; 31.1	—
SECONDARY Changes From Baseline in Intraepithelial Lymphocyte (IEL) Density in Duodenum Biopsy After 2-week GC	20.68; 17.36	—
SECONDARY Incidence and Severity of Treatment Emergent Adverse Events (TEAE) as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE)	25; 22; 1; 0; 0; 1	—
SECONDARY Incidence by Visit of KAN-101 Antidrug Antibody (ADA)	0; 0; 3; 5	—
SECONDARY KAN-101 Plasma Concentration: AUCinf	NA	—
SECONDARY KAN-101 Plasma Concentration: AUClast	NA	—
SECONDARY KAN-101 Plasma Concentration: Cmax	3141.9; 4107.9	—
SECONDARY KAN-101 Plasma Concentration: Tmax	0.7; 0.6	—
SECONDARY KAN-101 Plasma Concentration: T1/2	NA	—

Summary

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06001177). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.