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A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in People With Celiac Disease

Sponsor
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05574010
Collaborator
Pfizer (Industry)
138
Enrollment
2
Locations
7
Arms
28.6
Anticipated Duration (Months)
69
Patients Per Site
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to evaluate the Pharmacodynamic (PD), safety, tolerability, Pharmacokinetic (PK), and plasma biomarker response of KAN-101 in participants with Celiac Disease (CeD).

Condition or Disease Intervention/Treatment Phase
  • Drug: Cohort 1 in Part A
  • Drug: Cohort 2 in Part A
  • Drug: Cohort 3 in Part A
  • Other: Placebo: Group 1 in Part B
  • Drug: Group 2 in Part B
  • Drug: Group 3 in Part B
  • Drug: Group 4 in Part B
 Phase 1/Phase 2

Detailed Description

The study is a 2-part, multicenter Phase 1b/2 study of KAN-101 in participants with Celiac

Disease (CeD) on a gluten free diet (GFD). The 2 parts include:

  • Part A - Open-label, multiple ascending dose

  • Part B - Double-blind, placebo-controlled, parallel design

Part A is a Phase 1b, open-label, multiple ascending dose (MAD) study design to assess the safety, tolerability, and pharmacokinetics (PK) of KAN-101 in adult participants (18 to 70 years inclusive) with histology-confirmed CeD. Up to 18 participants who meet study inclusion/exclusion criteria will receive 1 of 3 dose levels of KAN-101. The overall study duration will be about 56 days, including up to 28 days of screening, 7 days of treatment and 21 days of follow up. There will be a gluten challenge test (GC) on Day 15.

Part B is a Phase 2, double-blind, placebo-controlled, parallel design study to characterize the biomarker response following GC, safety, tolerability, and PK of KAN-101 in adult participants with histology-confirmed CeD. 120 participants (30 participants per dose group) will be randomized 1:1:1:1 and stratified by participation in a biopsy substudy to 4 treatment groups: placebo and 3 treatment groups with KAN-101 doses to be determined based on information obtained from Part A.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
138 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Part A: This part of the study is an open label with up to 6 participants in each dose cohort. There will be 3 dose cohorts. Part B: This part of the study has a randomized, double- blinded, placebo-controlled, parallel study design.Part A: This part of the study is an open label with up to 6 participants in each dose cohort. There will be 3 dose cohorts. Part B: This part of the study has a randomized, double- blinded, placebo-controlled, parallel study design.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Part A is open label Part B is a double-blinded study. Study participants and their caregivers, investigators and other site staff, and sponsor staff involved in the study team will be blinded.
Primary Purpose:
Treatment
Official Title:
A Phase 1B Open-label/Phase 2 Double-blind Placebo- Controlled Study for Pharmacodynamic (PD) Activity, Pharmacokinetics (PK), Safety, and Tolerability of KAN-101 In Patients With Celiac Disease (CeD)
Actual Study Start Date :
Nov 15, 2022
Anticipated Primary Completion Date :
Apr 17, 2024
Anticipated Study Completion Date :
Apr 2, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1 in Part A

All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 1

Drug: Cohort 1 in Part A
Dose 1 KAN-101 Intravenous (IV) infusion
Other Names:
  • KAN-101

    		•
    Experimental: Cohort 2 in Part A

    All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 2

    Drug: Cohort 2 in Part A
    Dose 2 KAN-101 Intravenous (IV) infusion
    Other Names:
  • KAN-101

    		•
    Experimental: Cohort 3 in Part A

    All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 3

    Drug: Cohort 3 in Part A
    Dose 3 KAN-101 Intravenous (IV) infusion
    Other Names:
  • KAN-101

    		•
    Placebo Comparator: Group 1 in Part B

    All eligible Part B participants will receive 3 intravenous (IV) infusions of placebo

    Other: Placebo: Group 1 in Part B
    Placebo Intravenous (IV) infusion
    Other Names:
  • Placebo

    		•
    Experimental: Group 2 in Part B

    All eligible Part B participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 4

    Drug: Group 2 in Part B
    Dose 4 KAN-101 Intravenous (IV) infusion
    Other Names:
  • KAN-101

    		•
    Experimental: Group 3 in Part B

    All eligible Part B participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 5

    Drug: Group 3 in Part B
    Dose 5 KAN-101 Intravenous (IV) infusion
    Other Names:
  • KAN-101

    		•
    Experimental: Group 4 in Part B

    All eligible Part B participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 6

    Drug: Group 4 in Part B
    Dose 6 KAN-101 Intravenous (IV) infusion
    Other Names:
  • KAN-101

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence and severity of TEAEs as assessed by common terminology criteria for adverse events (CTCAE) in Part A [28 days]

      Primary endpoint in Part A. CTCAE is a scale with 5 grades to assess AE severity.

    2. Change in magnitude of IL-2 response pre- and post-GC in peripheral blood in Part B [Baseline to Day 15]

      Primary endpoint in Part B.

    Secondary Outcome Measures

    1. KAN-101 plasma exposure in Part A: AUCinf [0 (pre-dose) and up to 7 hours post dose]

      PK sample collection at pre- dose and post dose timepoints in Part A.

    2. KAN-101 plasma exposure in Part A: AUClast [0 (pre-dose) and up to 7 hours post dose]

      PK sample collection at pre- dose and post dose timepoints in Part A.

    3. KAN-101 plasma exposure in Part A: Cmax [0 (pre-dose) and up to 7 hours post dose]

      PK sample collection at pre- dose and post dose timepoints in Part A.

    4. KAN-101 plasma exposure in Part A: Tmax [0 (pre-dose) and up to 7 hours post dose]

      PK sample collection at pre- dose and post dose timepoints in Part A.

    5. KAN-101 plasma exposure in Part A: t½ [0 (pre-dose) and up to 7 hours post dose]

      PK sample collection at pre- dose and post dose timepoints in Part A.

    6. KAN-101 plasma exposure in Part B: AUCinf [0 (pre-dose) and up to 4 hours post dose]

      PK sample collection at pre- dose and post dose timepoints in Part B

    7. KAN-101 plasma exposure in Part B: AUClast [0 (pre-dose) and up to 4 hours post dose]

      PK sample collection at pre- dose and post dose timepoints in Part B.

    8. KAN-101 plasma exposure in Part B: Cmax [0 (pre-dose) and up to 4 hours post dose]

      PK sample collection at pre- dose and post dose timepoints in Part B.

    9. KAN-101 plasma exposure in Part B: Tmax [0 (pre-dose) and up to 4 hours post dose]

      PK sample collection at pre- dose and post dose timepoints in Part B.

    10. KAN-101 plasma exposure in Part B: t½ [0 (pre-dose) and up to 4 hours post dose]

      PK sample collection at pre- dose and post dose timepoints in Part B.

    11. Incidence and severity of TEAE as assessed by the CTCAE in Part B. [Week 52]

      Secondary endpoint in Part B

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Previous diagnosis of celiac disease based on histology and positive celiac serology

    • HLA-DQ2.5 genotype

    • Gluten-free diet for at least 12 months

    • Negative or weak positive for transglutaminase IgA and negative or weak positive for DGP-IgA/IgG during screening

    Exclusion Criteria:

    • Refractory celiac disease

    • HLA-DQ8 genotype

    • Previous oral gluten challenge within 12 months

    • Selective IgA deficiency

    • Diagnosis of Type-1 diabetes

    • Active gastrointestinal diseases

    • History of dermatitis herpetiformis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prism Research LLC dba Nucleus Network Saint Paul Minnesota United States 55114
    2 Aventiv Research, Inc. d/b/a Centricity Research Columbus Ohio United States 43213

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Marcie Fowler, PhD, Anokion SA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
    ClinicalTrials.gov Identifier:
    NCT05574010
    Other Study ID Numbers:
    • KAN-101-02
    First Posted:
    Oct 10, 2022
    Last Update Posted:
    Jan 20, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
    celiac disease
    HLA-DQ2.5
    gluten free diet
    Additional relevant MeSH terms:
    Celiac Disease

    Study Results

    No Results Posted as of Jan 20, 2023