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)

ClinicalTrials.gov processed this data on June 11, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

RECRUITING (See Contacts and Locations)
Verified June 2024 by Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA, Pfizer

Sponsor

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

Information Provided by (Responsible Party)

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

Clinicaltrials.gov Identifier

NCT05574010
Other Study ID Numbers: KAN-101-02
First Submitted: October 7, 2022
First Posted: October 10, 2022
Last Update Posted: June 12, 2024
Last Verified: June 2024
History of Changes

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Study 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.
Condition or Disease Intervention/Treatment
  • Celiac Disease
  • Drug: Cohort 1 in Part A
  • Drug: Cohort 2 in Part A
  • Other: Placebo: Group 1 in Part B and Part C
  • Drug: Group 2 in Part B and Part C
  • Drug: Group 3 in Part B and Part C
  • Drug: Group 4 in Part B and Part C

Study Design

Study TypeInterventional
Anticipated Enrollment126 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA 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)
Study Start DateNovember 15, 2022
Anticipated Primary Completion DateDecember 31, 2024
Anticipated Study Completion DateDecember 31, 2025

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • 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
  • 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
    • 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
      • 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
        • 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
          • 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

            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
            3. Change in magnitude of IL-2 response pre- and post-GC in peripheral blood [0 (pre-GC) and 4 hours post-GC on Day 15]
              Primary endpoint in Part C

            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 and Part C: AUCinf [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
            7. KAN-101 plasma exposure in Part B and Part C: AUClast [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.
            8. KAN-101 plasma exposure in Part B and Part C: Cmax [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.
            9. KAN-101 plasma exposure in Part B and Part C: Tmax [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.
            10. KAN-101 plasma exposure in Part B and Part C: t½ [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.
            11. Incidence and severity of TEAE as assessed by the CTCAE in Part B and Part C. [Week 52]
              Secondary endpoint in Part B and Part C

            Eligibility Criteria

            Ages Eligible for Study 18 Years to 70 Years (Adult, Older Adult)
            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

            Sponsors and Collaborators Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA, Pfizer
            Pfizer
            Locations
            • University of Alabama at Birmingham | Birmingham, Alabama, United States, 35233
            • Anaheim Clinical Trials, LLC | Anaheim, California, United States, 92801
            • GCP Research | Saint Petersburg, Florida, United States, 33705
            • Agile Clinical Research Trials | Sandy Springs, Georgia, United States, 30328
            • Sneeze, Wheeze & Itch Associates, LLC | Normal, Illinois, United States, 61761
            • Indiana University Health University Hospital | Indianapolis, Indiana, United States, 46202
            • University of Iowa | Iowa City, Iowa, United States, 52242
            • Mayo Clinic | Rochester, Minnesota, United States, 55905
            • Prism Research LLC dba Nucleus Network | Saint Paul, Minnesota, United States, 55114
            • Washington University School of Medicine | Saint Louis, Missouri, United States, 63110
            • Quality Clinical Research | Omaha, Nebraska, United States, 68114
            • North Carolina Clinical Research | Raleigh, North Carolina, United States, 27607
            • Aventiv Research, Inc. d/b/a Centricity Research | Columbus, Ohio, United States, 43213
            • Great Lakes Gastroenterology Research, LLC | Mentor, Ohio, United States, 44060
            • Northshore Gastroenterology Research, LLC | Westlake, Ohio, United States, 44145
            • Vanderbilt University Medical Center | Nashville, Tennessee, United States, 37212
            • The University of Texas Health Science Center at Houston | Houston, Texas, United States, 77030
            • Digestive Research of Central Texas | Waco, Texas, United States, 76712
            • Advanced Research Institute | Ogden, Utah, United States, 84405
            • Velocity Clinical Research, Salt Lake City | West Jordan, Utah, United States, 84088
            • Royal Adelaide Hospital | Adelaide, South Australia, Australia, 5000
            • Box Hill Hospital | Box Hill, Victoria, Australia, 3128
            • The Royal Melbourne Hospital | Parkville, Victoria, Australia, 3050
            • St John of God Midland Public and Private Hospitals | Midland, Western Australia, Australia, 6056
            • PCRN Trials | Takapuna, Auckland, New Zealand, 0622
            • P3 Research - Tauranga | Tauranga, Bay Of Plenty, New Zealand, 3110
            • P3 Research - Hawke's Bay | Hastings, Hawke's Bay, New Zealand, 4122
            • P3 Research - Dunedin | Dunedin, Otago, New Zealand, 9016
            • P3 Research - Palmerston North | Paraparaumu, Wellington, New Zealand, 5032
            • Optimal Clinical Trials | Auckland, New Zealand, 1023
            • Waikato Hospital | Hamilton, New Zealand, 3204
            • P3 Research - Wellington | Wellington, New Zealand, 6021
            Investigators