Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    kanyos
Previous Study | Return to List | Next Study

Assessment of KAN-101 in Celiac Disease (ACeD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04248855
Recruitment Status : Completed
First Posted : January 30, 2020
Last Update Posted : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
Anokion SA ( Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA )

Tracking Information
First Submitted Date  ICMJE January 28, 2020
First Posted Date  ICMJE January 30, 2020
Last Update Posted Date November 22, 2021
Actual Study Start Date  ICMJE January 21, 2020
Actual Primary Completion Date October 8, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
  • Geometric mean of maximum plasma concentration (Cmax) [ Time Frame: Up to 15 days ]
  • Area under the plasma concentration-time curve from time 0 to the last measurable time point (AUC last) [ Time Frame: Up to 15 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of KAN-101 in Celiac Disease (ACeD)
Official Title  ICMJE A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of KAN-101 in Patients With Celiac Disease (ACeD)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Celiac Disease
Intervention  ICMJE
  • Drug: KAN-101
    Intravenous (IV) infusion
  • Drug: Placebo
    Intravenous (IV) infusion
Study Arms  ICMJE
  • Experimental: SAD Cohort 1
    All enrolled patients will receive one dose of KAN-101 Dose A
    Intervention: Drug: KAN-101
  • Experimental: SAD Cohort 2
    All enrolled patients will receive one dose of KAN-101 Dose B
    Intervention: Drug: KAN-101
  • Experimental: SAD Cohort 3
    All enrolled patients will receive one dose of KAN-101 Dose C
    Intervention: Drug: KAN-101
  • Experimental: SAD Cohort 4
    All enrolled patients will receive one dose of KAN-101 Dose D
    Intervention: Drug: KAN-101
  • Experimental: MAD Cohort 5
    All randomized patients will receive 3 doses of either KAN-101 Dose A or placebo
    Interventions:
    • Drug: KAN-101
    • Drug: Placebo
  • Experimental: MAD Cohort 6
    All randomized patients will receive 3 doses of either KAN-101 Dose B or placebo
    Interventions:
    • Drug: KAN-101
    • Drug: Placebo
  • Experimental: MAD Cohort 7
    All randomized patients will receive 3 doses of either KAN-101 Dose C or placebo
    Interventions:
    • Drug: KAN-101
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2021)
41
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2020)
36
Actual Study Completion Date  ICMJE October 8, 2021
Actual Primary Completion Date October 8, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04248855
Other Study ID Numbers  ICMJE KAN-101-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anokion SA ( Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA )
Study Sponsor  ICMJE Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Anokion SA
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP