NCT05574010

A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)

A Phase 1B Open-label/Phase 2 Double-blind Placebo- Controlled Study for Pharmacodynamic (PD) Activity, Pharmacokinetics (PK), Safety, and Tolerability of KAN-101 In Patients With Celiac Disease (CeD)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 128 (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

This study is to evaluate the Pharmacodynamic (PD), safety, tolerability, Pharmacokinetic (PK), and plasma biomarker response of KAN-101 in participants with Celiac Disease (CeD).

Detailed description

The study is a 3-part, multicenter Phase 1b/2 study of KAN-101 in participants with Celiac Disease (CeD) on a gluten free diet (GFD). The 3 parts include: * Part A - Open-label, multiple ascending dose * Part B - Double-blind, placebo-controlled, parallel design * Part C - Double-blind, placebo-controlled, parallel design Part A is a Phase 1b, open-label, multiple ascending dose (MAD) study design to assess the safety, tolerability, and pharmacokinetics (PK) of KAN-101 in adult participants (18 to 70 years inclusive) with histology-confirmed CeD. Up to 12 participants who meet study inclusion/exclusion criteria will receive 1 of 2 dose levels of KAN-101. The overall study duration will be about 56 days, including up to 28 days of screening, 7 days of treatment and 21 days of follow up. There will be a gluten challenge test (GC) on Day 15. Parts B and C are Phase 2, double-blind, placebo-controlled, parallel design study to characterize the biomarker response following GC, safety, tolerability, and PK of KAN-101 in adult participants with histology-confirmed CeD. Approximately 16 participants (4 participants per dose group) will be enrolled in Part B and 104 participants (26 participants per dose group) enrolled into Part C. Participants will be randomized 1:1:1:1 and stratified by participation in a biopsy substudy to 4 treatment groups: placebo and 3 treatment groups with KAN-101 doses based on information obtained from Part A.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
DRUG	Cohort 1 in Part A	Dose 1 KAN-101 Intravenous (IV) infusion
DRUG	Cohort 2 in Part A	Dose 2 KAN-101 Intravenous (IV) infusion
OTHER	Placebo: Group 1 in Part B and Part C	Placebo Intravenous (IV) infusion
DRUG	Group 2 in Part B and Part C	Dose 3 KAN-101 Intravenous (IV) infusion
DRUG	Group 3 in Part B and Part C	Dose 4 KAN-101 Intravenous (IV) infusion
DRUG	Group 4 in Part B and Part C	Dose 5 KAN-101 Intravenous (IV) infusion

Timeline

• Start date: 2022-11-15
• Primary completion: 2024-11-29
• Completion: 2025-05-19
• First posted: 2022-10-10
• Last updated: 2026-03-10
• Results posted: 2026-03-10

Locations

36 sites across 3 countries: United States, Australia, New Zealand

Regulatory

• FDA-regulated drug study