Assessment of KAN-101 in Celiac Disease (ACeD)

NCT04248855 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: KAN-101-01
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 13

Brief Summary

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

1. 1.Part A - first in human study in which patients receive a single dose of KAN-101
2. 2.Part B - patients will receive three doses of either KAN-101 or placebo

Conditions

Celiac Disease

Keywords

Phase 1; Double blind; Multicenter

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)

  Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher

  Up to 28 Days

Secondary Outcomes (2)

• Cmax

  0, 7, 15, 30, 60, 120, 180, 240, 300, 360 minutes post dose on Days 1 and and 7

• AUC Last

  0, 7, 15, 30, 60, 120, 180, 240, 300, 360 minutes post dose on Days 1 and and 7

Study Arms (7)

SAD Cohort 1

EXPERIMENTAL

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

Drug: KAN-101

SAD Cohort 2

EXPERIMENTAL

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

Drug: KAN-101

SAD Cohort 3

EXPERIMENTAL

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

Drug: KAN-101

SAD Cohort 4

EXPERIMENTAL

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

Drug: KAN-101

MAD Cohort 5

EXPERIMENTAL

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

Drug: KAN-101; Drug: Placebo

MAD Cohort 6

EXPERIMENTAL

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

Drug: KAN-101; Drug: Placebo

MAD Cohort 7

EXPERIMENTAL

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

Drug: KAN-101; Drug: Placebo

Interventions

KAN-101 DRUG

Intravenous (IV) infusion

MAD Cohort 5; MAD Cohort 6; MAD Cohort 7; SAD Cohort 1; SAD Cohort 2; SAD Cohort 3; SAD Cohort 4

Placebo DRUG

Intravenous (IV) infusion

MAD Cohort 5; MAD Cohort 6; MAD Cohort 7

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 70 years inclusive
• 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
• Has HLA-DQ2.5 genotype (HLA-DQA1\*05 and HLA-DQB1\*02) (homozygotes or heterozygotes)
• Has followed a GFD for \> 12 months immediately prior to study entry
• Negative or weak positive for tTG-IgA and negative or weak positive for DGP-IgA/IgG during screening
• Male or female. Females of childbearing potential must use at least 2 acceptable birth control methods
• Capable of understanding and complying with protocol requirements
• Patient understands and has signed the informed consent form

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (13)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Innovative Medical Research of South Florida

Aventura, Florida, 33180, United States

Location

GCP Research

St. Petersburg, Florida, 33705, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Parexel International- EPCU Baltimore

Baltimore, Maryland, 21225, United States

Location

West Michigan Clinical Research Center

Wyoming, Michigan, 49519, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Celiac Disease Center at Columbia University

New York, New York, 10032, United States

Location

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Aventiv Research

Columbus, Ohio, 43213, United States

Location

WR-ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

Related Publications (1)

• 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.

  PMID: 37329900 DERIVED

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Kanyos Bio (A wholly owned subsidiary of Anokion SA)

clinicaltrials@anokion.com

+1 857-320-6607

Study Officials

• Study Director

  Kanyos Bio, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 30, 2020
• Study Start: January 21, 2020
• Primary Completion: October 8, 2021
• Study Completion: October 8, 2021
• Last Updated: August 6, 2024
• Results First Posted: March 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)