A Phase 2a Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of KAN-101 In Participants With Celiac Disease

ClinicalTrials.gov processed this data on June 10, 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

NCT06001177
Other Study ID Numbers: KAN-101-03
First Submitted: August 7, 2023
First Posted: August 21, 2023
Last Update Posted: June 11, 2024
Last Verified: June 2024
History of Changes

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Study Description

Study KAN-101-03 is a multi-center, double-blind, placebo-controlled Phase 2a study to examine whether KAN-101 confers protection from gluten exposure induced histological changes in the duodenum and to further evaluate the safety/tolerability of KAN-101 in adult participants (≥18 years) with CeD on a gluten free diet. Up to 52 participants who meet study inclusion/exclusion criteria will be randomized 1:1 to receive KAN-101 or placebo.
Condition or Disease Intervention/Treatment
  • Celiac Disease
  • Coeliac Disease
  • Drug: KAN-101
  • Drug: Placebo

Study Design

Study TypeInterventional
Anticipated Enrollment52 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA Phase 2a Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of KAN-101 In Participants With Celiac Disease
Study Start DateDecember 13, 2023
Anticipated Primary Completion DateMarch 2025
Anticipated Study Completion DateJune 2025

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Group 1
    • All eligible participants will receive 3 intravenous (IV) infusions of KAN-101
  • Drug: KAN-101
    • Dose KAN-101 Intravenous (IV) Infusion
  • Group 2
    • All eligible participants will receive 3 intravenous (IV) infusions of placebo
  • Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Changes from baseline in Vh:Cd as assessed by esophagogastroduodenoscopy with biopsy after 2-week gluten challenge (GC) [29 days]
      Vh:Cd is the ratio of villous height to crypt depth, a histological assessment

    Secondary Outcome Measures

    1. Change in magnitude of IL-2 response from Day 15 (first day of GC) pre GC to Day 15 post GC [15 days]
      IL-2 is interleukin-2
    2. Changes from baseline in IEL density in duodenum biopsy after 2-week GC [29 days]
      IEL is intraepithelial lymphocyte
    3. Incidence and severity of treatment emergent adverse events as assessed by the CTCAE [42 days]
      Common Terminology Criteria for Adverse Events (CTCAE) is a scale with 5 grades to assess Adverse Event (AE) severity
    4. Incidence of KAN-101 ADA [42 days]
      ADA is antidrug antibody
    5. Titer of KAN-101 ADA [42 days]
      ADA is antidrug antibody
    6. KAN-101 plasma concentration: AUCinf [7 days]
      Pharmacokinetic (PK) sample collection at pre and post dose timepoints
    7. KAN-101 plasma concentration: AUClast [7 days]
      PK sample collection at pre and post dose timepoints
    8. KAN-101 plasma concentration: Cmax [7 days]
      PK sample collection at pre and post dose timepoints
    9. KAN-101 plasma concentration: Tmax [7 days]
      PK sample collection at pre and post dose timepoints
    10. KAN-101 plasma concentration: T1/2 [7 days]
      PK sample collection at pre and post dose timepoints

    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
    • Screening intestinal biopsy demonstrating Vh:Cd ratio of 2.3 or higher
    Exclusion Criteria
    • Refractory celiac disease
    • HLA-DQ8 genotype
    • Selective IgA deficiency
    • Diagnosis of type-I diabetes
    • Other 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
    • Peak Gastroenterology Associates | Colorado Springs, Colorado, United States, 80907
    • Unlimited Medical Research Group | Hialeah Gardens, Florida, United States, 33018
    • Homestead Associates in Research Inc. | Miami, Florida, United States, 33032
    • Ochsner Clinic Foundation | New Orleans, Louisiana, United States, 70121
    • Beth Israel Deaconess Medical Center | Boston, Massachusetts, United States, 02215
    • Centre Intégré de Santé et de Services Sociaux-Chaudière Appalaches - Hôtel-Dieu de Lévis | Lévis, Quebec, Canada, G6V 3Z1
    • Hopital Du Sacre-Coeur De Montreal | Montréal, Quebec, Canada, H4J 1C5
    • Studiengesellschaft BSF Unternehmergesellschaft | Halle, Sachsen-Anhalt, Germany, 6108
    • Centrum Medyczne Med-Gastr Sp. z o.o. | Łódź, Łódzkie, Poland, 91-034
    • MZ Badania Slowik Zymla Spolka Jawna | Knurów, Śląskie, Poland, 44-190
    Investigators