Assessment of KAN-101 in Celiac Disease (ACeD)

Celiac Disease Clinical Trial

Official title:

A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of KAN-101 in Patients With Celiac Disease (ACeD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04248855
• Other study ID #: KAN-101-01
• Status: Completed
• Phase: Phase 1
• Start date: January 21, 2020
• Est. completion date: October 8, 2021

Study information

• Verified date: September 2023
• Source: Anokion SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 8, 2021
• Est. primary completion date: October 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Key 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

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Drug:
• KAN-101
Intravenous (IV) infusion
• Placebo
Intravenous (IV) infusion

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California
United States	Innovative Medical Research of South Florida	Aventura	Florida
United States	Parexel International- EPCU Baltimore	Baltimore	Maryland
United States	WR-ClinSearch, LLC	Chattanooga	Tennessee
United States	Aventiv Research	Columbus	Ohio
United States	Tandem Clinical Research	Marrero	Louisiana
United States	Celiac Disease Center at Columbia University	New York	New York
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	Mayo Clinic	Rochester	Minnesota
United States	GCP Research	Saint Petersburg	Florida
United States	Diablo Clinical Research	Walnut Creek	California
United States	Advanced Clinical Research	West Jordan	Utah
United States	West Michigan Clinical Research Center	Wyoming	Michigan

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

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