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A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)
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).
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-11-15
Primary completion: 2024-12-31
Study completion finish: 2025-12-31
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT05574010
Intervention or treatment
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
Conditions
- • Celiac Disease
Find a site
Closest Location:
Royal Adelaide Hospital
Research sites nearby
Select from list below to view details:
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Campbelltown Hospital
Campbelltown, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Cohort 1 in Part A
| DRUG: Cohort 1 in Part A
|
EXPERIMENTAL: Cohort 2 in Part A
| DRUG: Cohort 2 in Part A
|
PLACEBO_COMPARATOR: Group 1 in Part B and Part C
| OTHER: Placebo: Group 1 in Part B and Part C
|
EXPERIMENTAL: Group 2 in Part B and Part C
| DRUG: Group 2 in Part B and Part C
|
EXPERIMENTAL: Group 3 in Part B and Part C
| DRUG: Group 3 in Part B and Part C
|
EXPERIMENTAL: Group 4 in Part B and Part C
| DRUG: Group 4 in Part B and Part C
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Incidence and severity of TEAEs as assessed by common terminology criteria for adverse events (CTCAE) in Part A | Primary endpoint in Part A. CTCAE is a scale with 5 grades to assess AE severity. | 28 days |
| Change in magnitude of IL-2 response pre- and post-GC in peripheral blood in Part B | Primary endpoint in Part B | Baseline to Day 15 |
| Change in magnitude of IL-2 response pre- and post-GC in peripheral blood | Primary endpoint in Part C | 0 (pre-GC) and 4 hours post-GC on Day 15 |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| KAN-101 plasma exposure in Part A: AUCinf | PK sample collection at pre- dose and post dose timepoints in Part A. | 0 (pre-dose) and up to 7 hours post dose |
| KAN-101 plasma exposure in Part A: AUClast | PK sample collection at pre- dose and post dose timepoints in Part A. | 0 (pre-dose) and up to 7 hours post dose |
| KAN-101 plasma exposure in Part A: Cmax | PK sample collection at pre- dose and post dose timepoints in Part A. | 0 (pre-dose) and up to 7 hours post dose |
| KAN-101 plasma exposure in Part A: Tmax | PK sample collection at pre- dose and post dose timepoints in Part A. | 0 (pre-dose) and up to 7 hours post dose |
| KAN-101 plasma exposure in Part A: t½ | PK sample collection at pre- dose and post dose timepoints in Part A. | 0 (pre-dose) and up to 7 hours post dose |
| KAN-101 plasma exposure in Part B and Part C: AUCinf | PK sample collection at pre- dose and post dose timepoints in Part B and Part C | 0 (pre-dose) and up to 4 hours post dose |
| KAN-101 plasma exposure in Part B and Part C: AUClast | PK sample collection at pre- dose and post dose timepoints in Part B and Part C. | 0 (pre-dose) and up to 4 hours post dose |
| KAN-101 plasma exposure in Part B and Part C: Cmax | PK sample collection at pre- dose and post dose timepoints in Part B and Part C. | 0 (pre-dose) and up to 4 hours post dose |
| KAN-101 plasma exposure in Part B and Part C: Tmax | PK sample collection at pre- dose and post dose timepoints in Part B and Part C. | 0 (pre-dose) and up to 4 hours post dose |
| KAN-101 plasma exposure in Part B and Part C: t½ | PK sample collection at pre- dose and post dose timepoints in Part B and Part C. | 0 (pre-dose) and up to 4 hours post dose |
| Incidence and severity of TEAE as assessed by the CTCAE in Part B and Part C. | Secondary endpoint in Part B and Part C | Week 52 |
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