Assessment of KAN-101 in Celiac Disease (ACeD)

Phase 1

Completed

• Conditions: Celiac Disease
• Interventions: Drug: KAN-101; Drug: Placebo

• Registration Number: NCT04248855
• Lead Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA

Brief Summary

A safety study of KAN-101 in patients with celiac disease. The study has two parts:

1. Part A - first in human study in which patients receive a single dose of KAN-101

2. Part B - patients will receive three doses of either KAN-101 or placebo

Detailed Description

Study KAN-101-01 is a Phase 1, FIH study designed to evaluate the safety and tolerability of KAN-101 in patients with celiac disease on a gluten free diet (GFD).

An overview of the two parts and proposed dose groups is given below:

1. Part A (SAD): Patients will receive a single dose of KAN-101.

2. Part B (MAD): Patients will receive three doses of either KAN-101 or placebo.

Study Timeline

• Study Start: 2020-01-21
• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-30
• Primary Completion: 2021-10-08
• Study Completion: 2021-10-08
• Results First Submitted: 2022-10-04
• Results First Submitted QC: 2023-09-14
• Results First Posted: 2024-03-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1. Adults aged 18 to 70 years inclusive
2. Diagnosed with celiac disease based on positive serology (eg, tissue transglutaminase IgA antibody and/or deamidated gliadin peptide IgG) and intestinal histology consistent with ≥ Marsh Type II or with evidence of villous atrophy
3. Has HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygotes or heterozygotes)
4. Has followed a GFD for > 12 months immediately prior to study entry
5. Negative or weak positive for tTG-IgA and negative or weak positive for DGP-IgA/IgG during screening
6. Male or female. Females of childbearing potential must use at least 2 acceptable birth control methods
7. Capable of understanding and complying with protocol requirements
8. Patient understands and has signed the informed consent form

Key

Exclusion Criteria

1. Refractory celiac disease
2. Selective IgA deficiency
3. Positive for HLA-DQ8 (DQA1*03, DQB1*0302)
4. Previous treatment with tolerance-inducing therapies for celiac disease
5. Known wheat allergy
6. Part B only: History of hyperacute or prolonged symptoms following gluten exposure
7. Uncontrolled or significant medical conditions (including active infections or chronic hepatitis) which, in the opinion of the Investigator, preclude participation
8. History of dermatitis herpetiformis
9. Pregnant or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
MAD Cohort 7	KAN-101	All randomized patients will receive 3 doses of either KAN-101 Dose C or placebo
MAD Cohort 7	Placebo	All randomized patients will receive 3 doses of either KAN-101 Dose C or placebo
SAD Cohort 1	KAN-101	All enrolled patients will receive one dose of KAN-101 Dose A
SAD Cohort 3	KAN-101	All enrolled patients will receive one dose of KAN-101 Dose C
SAD Cohort 4	KAN-101	All enrolled patients will receive one dose of KAN-101 Dose D
MAD Cohort 5	Placebo	All randomized patients will receive 3 doses of either KAN-101 Dose A or placebo
MAD Cohort 6	Placebo	All randomized patients will receive 3 doses of either KAN-101 Dose B or placebo
SAD Cohort 2	KAN-101	All enrolled patients will receive one dose of KAN-101 Dose B
MAD Cohort 5	KAN-101	All randomized patients will receive 3 doses of either KAN-101 Dose A or placebo
MAD Cohort 6	KAN-101	All randomized patients will receive 3 doses of either KAN-101 Dose B or placebo

Primary Outcome Measures

Name	Time	Method
Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)	Up to 28 Days	Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher

Secondary Outcome Measures

Name	Time	Method
Cmax	0, 7, 15, 30, 60, 120, 180, 240, 300, 360 minutes post dose on Days 1 and and 7	Geometric mean of maximum drug concentration (Cmax)
AUC Last	0, 7, 15, 30, 60, 120, 180, 240, 300, 360 minutes post dose on Days 1 and and 7	Area under the plasma concentration-time curve from time 0 to the last measurable time point (AUC last)

Trial Locations

Locations (13)

West Michigan Clinical Research Center; 🇺🇸 Wyoming, Michigan, United States

Aventiv Research; 🇺🇸 Columbus, Ohio, United States

Anaheim Clinical Trials; 🇺🇸 Anaheim, California, United States

Tandem Clinical Research; 🇺🇸 Marrero, Louisiana, United States

Celiac Disease Center at Columbia University; 🇺🇸 New York, New York, United States

Diablo Clinical Research; 🇺🇸 Walnut Creek, California, United States

WR-ClinSearch, LLC; 🇺🇸 Chattanooga, Tennessee, United States

North Carolina Clinical Research; 🇺🇸 Raleigh, North Carolina, United States

Parexel International- EPCU Baltimore; 🇺🇸 Baltimore, Maryland, United States

Advanced Clinical Research; 🇺🇸 West Jordan, Utah, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

GCP Research; 🇺🇸 Saint Petersburg, Florida, United States

Innovative Medical Research of South Florida; 🇺🇸 Aventura, Florida, United States