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

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

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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