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Assessment of KAN-101 in Celiac Disease (ACeD)

Primary Purpose

Celiac Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
KAN-101
Placebo
Sponsored by
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease focused on measuring Phase 1, Double blind, Multicenter

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Anaheim Clinical Trials
  • Diablo Clinical Research
  • GCP Research
  • Tandem Clinical Research
  • Parexel International- EPCU Baltimore
  • West Michigan Clinical Research Center
  • Mayo Clinic
  • Celiac Disease Center at Columbia University
  • North Carolina Clinical Research
  • Aventiv Research
  • Advanced Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

SAD Cohort 1

SAD Cohort 2

SAD Cohort 3

SAD Cohort 4

MAD Cohort 5

MAD Cohort 6

MAD Cohort 7

Arm Description

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Geometric mean of maximum plasma concentration (Cmax)
Area under the plasma concentration-time curve from time 0 to the last measurable time point (AUC last)

Full Information

First Posted
January 28, 2020
Last Updated
November 18, 2021
Sponsor
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
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1. Study Identification

Unique Protocol Identification Number
NCT04248855
Brief Title
Assessment of KAN-101 in Celiac Disease (ACeD)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
October 8, 2021 (Actual)
Study Completion Date
October 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A safety study of KAN-101 in patients with celiac disease. The study has two parts: Part A - first in human study in which patients receive a single dose of KAN-101 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: Part A (SAD): Patients will receive a single dose of KAN-101. Part B (MAD): Patients will receive three doses of either KAN-101 or placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
Phase 1, Double blind, Multicenter

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAD Cohort 1
Arm Type
Experimental
Arm Description
All enrolled patients will receive one dose of KAN-101 Dose A
Arm Title
SAD Cohort 2
Arm Type
Experimental
Arm Description
All enrolled patients will receive one dose of KAN-101 Dose B
Arm Title
SAD Cohort 3
Arm Type
Experimental
Arm Description
All enrolled patients will receive one dose of KAN-101 Dose C
Arm Title
SAD Cohort 4
Arm Type
Experimental
Arm Description
All enrolled patients will receive one dose of KAN-101 Dose D
Arm Title
MAD Cohort 5
Arm Type
Experimental
Arm Description
All randomized patients will receive 3 doses of either KAN-101 Dose A or placebo
Arm Title
MAD Cohort 6
Arm Type
Experimental
Arm Description
All randomized patients will receive 3 doses of either KAN-101 Dose B or placebo
Arm Title
MAD Cohort 7
Arm Type
Experimental
Arm Description
All randomized patients will receive 3 doses of either KAN-101 Dose C or placebo
Intervention Type
Drug
Intervention Name(s)
KAN-101
Intervention Description
Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenous (IV) infusion
Primary Outcome Measure Information:
Title
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
Time Frame
Up to 28 Days
Secondary Outcome Measure Information:
Title
Geometric mean of maximum plasma concentration (Cmax)
Time Frame
Up to 15 days
Title
Area under the plasma concentration-time curve from time 0 to the last measurable time point (AUC last)
Time Frame
Up to 15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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 Key Exclusion Criteria: 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
Facility Information:
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Diablo Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
GCP Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Parexel International- EPCU Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Facility Name
West Michigan Clinical Research Center
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Celiac Disease Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
North Carolina Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Aventiv Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessment of KAN-101 in Celiac Disease (ACeD)

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