The trial is taking place at:
N

North Carolina Clinical Research | Raleigh, NC

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

K

Kanyos Bio

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Celiac Disease

Treatments

Drug: Cohort 2 in Part A
Drug: Group 4 in Part B and Part C
Drug: Group 2 in Part B and Part C
Drug: Group 3 in Part B and Part C
Other: Placebo: Group 1 in Part B and Part C
Drug: Cohort 1 in Part A

Study type

Interventional

Funder types

Industry

Identifiers

NCT05574010
KAN-101-02

Details and patient eligibility

About

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).

Full 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.

Enrollment

126 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

126 participants in 6 patient groups, including a placebo group

Cohort 1 in Part A
Experimental group
Description:
All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 1
Treatment:
Drug: Cohort 1 in Part A
Cohort 2 in Part A
Experimental group
Description:
All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 2
Treatment:
Drug: Cohort 2 in Part A
Group 1 in Part B and Part C
Placebo Comparator group
Description:
All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of placebo
Treatment:
Other: Placebo: Group 1 in Part B and Part C
Group 2 in Part B and Part C
Experimental group
Description:
All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 3
Treatment:
Drug: Group 2 in Part B and Part C
Group 3 in Part B and Part C
Experimental group
Description:
All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 4
Treatment:
Drug: Group 3 in Part B and Part C
Group 4 in Part B and Part C
Experimental group
Description:
All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 5
Treatment:
Drug: Group 4 in Part B and Part C

Trial contacts and locations

31

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Central trial contact

Kanyos Bio, Inc. (a wholly owned subsidiary of Anokion S.A.)

Data sourced from clinicaltrials.gov

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