Assessment of KAN-101 in Celiac Disease (ACeD)

NCT ID: NCT04248855

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-21
• Study Completion Date: 2021-10-08

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.

Conditions

Celiac Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SAD Cohort 1

All enrolled patients will receive one dose of KAN-101 Dose A

Group Type: EXPERIMENTAL

KAN-101

Intervention Type: DRUG

Intravenous (IV) infusion

SAD Cohort 2

All enrolled patients will receive one dose of KAN-101 Dose B

Group Type: EXPERIMENTAL

KAN-101

Intervention Type: DRUG

Intravenous (IV) infusion

SAD Cohort 3

All enrolled patients will receive one dose of KAN-101 Dose C

Group Type: EXPERIMENTAL

KAN-101

Intervention Type: DRUG

Intravenous (IV) infusion

SAD Cohort 4

All enrolled patients will receive one dose of KAN-101 Dose D

Group Type: EXPERIMENTAL

KAN-101

Intervention Type: DRUG

Intravenous (IV) infusion

MAD Cohort 5

All randomized patients will receive 3 doses of either KAN-101 Dose A or placebo

Group Type: EXPERIMENTAL

KAN-101

Intervention Type: DRUG

Intravenous (IV) infusion

Placebo

Intervention Type: DRUG

Intravenous (IV) infusion

MAD Cohort 6

All randomized patients will receive 3 doses of either KAN-101 Dose B or placebo

Group Type: EXPERIMENTAL

KAN-101

Intervention Type: DRUG

Intravenous (IV) infusion

Placebo

Intervention Type: DRUG

Intravenous (IV) infusion

MAD Cohort 7

All randomized patients will receive 3 doses of either KAN-101 Dose C or placebo

Group Type: EXPERIMENTAL

KAN-101

Intervention Type: DRUG

Intravenous (IV) infusion

Placebo

Intervention Type: DRUG

Intravenous (IV) infusion

Interventions

KAN-101

Intravenous (IV) infusion

Intervention Type: DRUG

Placebo

Intravenous (IV) infusion

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Kanyos Bio, Inc.

Locations

Anaheim Clinical Trials

Anaheim, California, United States

Diablo Clinical Research

Walnut Creek, California, United States

Innovative Medical Research of South Florida

Aventura, Florida, United States

GCP Research

St. Petersburg, Florida, United States

Tandem Clinical Research

Marrero, Louisiana, United States

Parexel International- EPCU Baltimore

Baltimore, Maryland, United States

West Michigan Clinical Research Center

Wyoming, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Celiac Disease Center at Columbia University

New York, New York, United States

North Carolina Clinical Research

Raleigh, North Carolina, United States

Aventiv Research

Columbus, Ohio, United States

WR-ClinSearch, LLC

Chattanooga, Tennessee, United States

Advanced Clinical Research

West Jordan, Utah, United States

Countries

United States

References

Murray JA, Wassaf D, Dunn K, Arora S, Winkle P, Stacey H, Cooper S, Goldstein KE, Manchanda R, Kontos S, Grebe KM. Safety and tolerability of KAN-101, a liver-targeted immune tolerance therapy, in patients with coeliac disease (ACeD): a phase 1 trial. Lancet Gastroenterol Hepatol. 2023 Aug;8(8):735-747. doi: 10.1016/S2468-1253(23)00107-3. Epub 2023 Jun 14.

Reference Type: DERIVED

PMID: 37329900 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

KAN-101-01

Identifier Type: -

Identifier Source: org_study_id