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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
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 2 dose cohorts. Part B and Part C: These parts of the study have a randomized, double- blinded, placebo-controlled, parallel study design.
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Part A is open label Part B and Part C are 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.

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Study Coordinator
205-962-6865

More Details

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

Study Contact

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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.