A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)

April 3, 2024 updated by: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA

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)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is a 3-part, multicenter Phase 1b/2 study of KAN-101 in participants with Celiac Disease (CeD) on a gluten free diet (GFD). The 3 parts include:

  • Part A - Open-label, multiple ascending dose
  • Part B - Double-blind, placebo-controlled, parallel design
  • Part C - 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 12 participants who meet study inclusion/exclusion criteria will receive 1 of 2 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.

Parts B and C are 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. Approximately 16 participants (4 participants per dose group) will be enrolled in Part B and 104 participants (26 participants per dose group) enrolled into Part C. Participants 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 based on information obtained from Part A.

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kanyos Bio, Inc. (a wholly owned subsidiary of Anokion S.A.)
  • Phone Number: +1 857-320-6607
  • Email: clinicaltrials@anokion.com

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
          • Study Coordinator
          • Phone Number: +61 8 7074 2200
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Recruiting
        • Box Hill Hospital
        • Contact:
          • Study Coordinator
          • Phone Number: 043-870-2279
      • Parkville, Victoria, Australia, 3050
        • Recruiting
        • The Royal Melbourne Hospital
        • Contact:
          • Study Coordinator
          • Phone Number: (03) 9342-8076
  • New Zealand
      • Auckland, New Zealand, 1023
        • Recruiting
        • Optimal Clinical Trials
        • Contact:
          • Study Coordinator
          • Phone Number: 649-303-4987
      • Hamilton, New Zealand, 3204
        • Recruiting
        • Waikato Hospital
        • Contact:
          • Study Coordinator
          • Phone Number: +64 2 154 9659
      • Wellington, New Zealand, 6021
        • Recruiting
        • P3 Research - Wellington
        • Contact:
          • Study Coordinator
          • Phone Number: 644-801-0002
    • Auckland
      • Takapuna, Auckland, New Zealand, 0622
        • Recruiting
        • PCRN Trials
        • Contact:
          • Study Coordinator
          • Phone Number: 649-242-3321
    • Bay Of Plenty
      • Tauranga, Bay Of Plenty, New Zealand, 3110
        • Recruiting
        • P3 Research - Tauranga
        • Contact:
          • Study Coordinator
          • Phone Number: 647-579-0453
    • Hawke's Bay
      • Hastings, Hawke's Bay, New Zealand, 4122
        • Withdrawn
        • P3 Research - Hawke's Bay
    • Otago
      • Dunedin, Otago, New Zealand, 9016
        • Recruiting
        • P3 Research - Dunedin
        • Contact:
          • Study Coordinator
          • Phone Number: 643-974-8174
    • Wellington
      • Paraparaumu, Wellington, New Zealand, 5032
        • Recruiting
        • P3 Research - Palmerston North
        • Contact:
          • Study Coordinator
          • Phone Number: 646-241-8009
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama At Birmingham
        • Contact:
          • Study Coordinator
          • Phone Number: 205-962-6865
    • California
      • Anaheim, California, United States, 92801
        • Recruiting
        • Anaheim Clinical Trials, LLC
        • Contact:
          • Study Coordinator
          • Phone Number: 949-295-7809
    • Florida
      • Saint Petersburg, Florida, United States, 33705
        • Recruiting
        • GCP Research
        • Contact:
          • Study Coordinator
          • Phone Number: 727-520-1427
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Recruiting
        • Agile Clinical Research Trials
        • Contact:
          • Study Coordinator
          • Phone Number: 404-400-2255
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health University Hospital
        • Contact:
          • Study Coordinator
          • Phone Number: 317-278-9294
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Contact:
          • Study Coordinator
          • Phone Number: 319-356-3935
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Study Coordinator
          • Phone Number: 507-284-3075
      • Saint Paul, Minnesota, United States, 55114
        • Recruiting
        • Prism Research LLC dba Nucleus Network
        • Contact:
          • Study Coordinator
          • Phone Number: 651-300-2888
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Quality Clinical Research
        • Contact:
          • Study Coordinator
          • Phone Number: 402-934-0044
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • North Carolina Clinical Research
        • Contact:
          • Study Coordinator
          • Phone Number: 919-881-0309
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Recruiting
        • Aventiv Research, Inc. d/b/a Centricity Research
        • Contact:
          • Study Coordinator
          • Phone Number: 614-501-6164
      • Mentor, Ohio, United States, 44060
        • Recruiting
        • Great Lakes Gastroenterology Research, LLC
        • Contact:
          • Study Coordinator
          • Phone Number: 440-205-1225
      • Westlake, Ohio, United States, 44145
        • Recruiting
        • Northshore Gastroenterology Research, LLC
        • Contact:
          • Study Coordinator
          • Phone Number: 440-250-7584
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Study Coordinator
          • Phone Number: 615-936-1745
    • Texas
      • Waco, Texas, United States, 76712
        • Recruiting
        • Digestive Research of Central Texas
        • Contact:
          • Study Coordinator
          • Phone Number: 210-900-5821
    • Utah
      • Ogden, Utah, United States, 84405
        • Recruiting
        • Advanced Research Institute
        • Contact:
          • Study Coordinator
          • Phone Number: 801-409-2040
      • West Jordan, Utah, United States, 84088
        • Recruiting
        • Velocity Clinical Research, Salt Lake City
        • Contact:
          • Study Coordinator
          • Phone Number: 801-542-8190

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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
Placebo Comparator: Group 1 in Part B and Part C
All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of placebo
Other: Placebo: Group 1 in Part B and Part C
Placebo Intravenous (IV) infusion
Other Names:
  • Placebo
Experimental: Group 2 in Part B and Part C
All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 3
Drug: Group 2 in Part B and Part C
Dose 3 KAN-101 Intravenous (IV) infusion
Other Names:
  • KAN-101
Experimental: Group 3 in Part B and Part C
All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 4
Drug: Group 3 in Part B and Part C
Dose 4 KAN-101 Intravenous (IV) infusion
Other Names:
  • KAN-101
Experimental: Group 4 in Part B and Part C
All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 5
Drug: Group 4 in Part B and Part C
Dose 5 KAN-101 Intravenous (IV) infusion
Other Names:
  • KAN-101

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of TEAEs as assessed by common terminology criteria for adverse events (CTCAE) in Part A
Time Frame: 28 days
Primary endpoint in Part A. CTCAE is a scale with 5 grades to assess AE severity.
28 days
Change in magnitude of IL-2 response pre- and post-GC in peripheral blood in Part B
Time Frame: Baseline to Day 15
Primary endpoint in Part B
Baseline to Day 15
Change in magnitude of IL-2 response pre- and post-GC in peripheral blood
Time Frame: 0 (pre-GC) and 4 hours post-GC on Day 15
Primary endpoint in Part C
0 (pre-GC) and 4 hours post-GC on Day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KAN-101 plasma exposure in Part A: AUCinf
Time Frame: 0 (pre-dose) and up to 7 hours post dose
PK sample collection at pre- dose and post dose timepoints in Part A.
0 (pre-dose) and up to 7 hours post dose
KAN-101 plasma exposure in Part A: AUClast
Time Frame: 0 (pre-dose) and up to 7 hours post dose
PK sample collection at pre- dose and post dose timepoints in Part A.
0 (pre-dose) and up to 7 hours post dose
KAN-101 plasma exposure in Part A: Cmax
Time Frame: 0 (pre-dose) and up to 7 hours post dose
PK sample collection at pre- dose and post dose timepoints in Part A.
0 (pre-dose) and up to 7 hours post dose
KAN-101 plasma exposure in Part A: Tmax
Time Frame: 0 (pre-dose) and up to 7 hours post dose
PK sample collection at pre- dose and post dose timepoints in Part A.
0 (pre-dose) and up to 7 hours post dose
KAN-101 plasma exposure in Part A: t½
Time Frame: 0 (pre-dose) and up to 7 hours post dose
PK sample collection at pre- dose and post dose timepoints in Part A.
0 (pre-dose) and up to 7 hours post dose
KAN-101 plasma exposure in Part B and Part C: AUCinf
Time Frame: 0 (pre-dose) and up to 4 hours post dose
PK sample collection at pre- dose and post dose timepoints in Part B and Part C
0 (pre-dose) and up to 4 hours post dose
KAN-101 plasma exposure in Part B and Part C: AUClast
Time Frame: 0 (pre-dose) and up to 4 hours post dose
PK sample collection at pre- dose and post dose timepoints in Part B and Part C.
0 (pre-dose) and up to 4 hours post dose
KAN-101 plasma exposure in Part B and Part C: Cmax
Time Frame: 0 (pre-dose) and up to 4 hours post dose
PK sample collection at pre- dose and post dose timepoints in Part B and Part C.
0 (pre-dose) and up to 4 hours post dose
KAN-101 plasma exposure in Part B and Part C: Tmax
Time Frame: 0 (pre-dose) and up to 4 hours post dose
PK sample collection at pre- dose and post dose timepoints in Part B and Part C.
0 (pre-dose) and up to 4 hours post dose
KAN-101 plasma exposure in Part B and Part C: t½
Time Frame: 0 (pre-dose) and up to 4 hours post dose
PK sample collection at pre- dose and post dose timepoints in Part B and Part C.
0 (pre-dose) and up to 4 hours post dose
Incidence and severity of TEAE as assessed by the CTCAE in Part B and Part C.
Time Frame: Week 52
Secondary endpoint in Part B and Part C
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Pfizer

Investigators

  • Study Director: Study Director, Anokion SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 7, 2022

First Submitted That Met QC Criteria

October 7, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAN-101-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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