A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)
- Conditions
- Celiac Disease
- Interventions
- Drug: Group 3 in Part B and Part CDrug: Group 4 in Part B and Part CDrug: Cohort 1 in Part ADrug: Cohort 2 in Part ADrug: Group 2 in Part B and Part C
- Registration Number
- NCT05574010
- Lead Sponsor
- Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
- Brief Summary
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).
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 126
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 3 in Part B and Part C 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 Group 4 in Part B and Part C 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 Cohort 1 in Part A Cohort 1 in Part A All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 1 Cohort 2 in Part A Cohort 2 in Part A All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 2 Group 2 in Part B and Part C 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
- Primary Outcome Measures
Name Time Method Change in magnitude of IL-2 response pre- and post-GC in peripheral blood 0 (pre-GC) and 4 hours post-GC on Day 15 Primary endpoint in Part C
Change in magnitude of IL-2 response pre- and post-GC in peripheral blood in Part B Baseline to Day 15 Primary endpoint in Part B
Incidence and severity of TEAEs as assessed by common terminology criteria for adverse events (CTCAE) in Part A 28 days Primary endpoint in Part A. CTCAE is a scale with 5 grades to assess AE severity.
- Secondary Outcome Measures
Name Time Method KAN-101 plasma exposure in Part B and Part C: Tmax 0 (pre-dose) and up to 4 hours post dose PK sample collection at pre- dose and post dose timepoints in Part B and Part C.
KAN-101 plasma exposure in Part A: AUCinf 0 (pre-dose) and up to 7 hours post dose PK sample collection at pre- dose and post dose timepoints in Part A.
KAN-101 plasma exposure in Part A: AUClast 0 (pre-dose) and up to 7 hours post dose PK sample collection at pre- dose and post dose timepoints in Part A.
KAN-101 plasma exposure in Part A: Cmax 0 (pre-dose) and up to 7 hours post dose PK sample collection at pre- dose and post dose timepoints in Part A.
KAN-101 plasma exposure in Part A: Tmax 0 (pre-dose) and up to 7 hours post dose PK sample collection at pre- dose and post dose timepoints in Part A.
KAN-101 plasma exposure in Part A: t½ 0 (pre-dose) and up to 7 hours post dose PK sample collection at pre- dose and post dose timepoints in Part A.
KAN-101 plasma exposure in Part B and Part C: AUCinf 0 (pre-dose) and up to 4 hours post dose PK sample collection at pre- dose and post dose timepoints in Part B and Part C.
KAN-101 plasma exposure in Part B and Part C: AUClast 0 (pre-dose) and up to 4 hours post dose PK sample collection at pre- dose and post dose timepoints in Part B and Part C.
KAN-101 plasma exposure in Part B and Part C: Cmax 0 (pre-dose) and up to 4 hours post dose PK sample collection at pre- dose and post dose timepoints in Part B and Part C.
KAN-101 plasma exposure in Part B and Part C: t½ 0 (pre-dose) and up to 4 hours post dose PK sample collection at pre- dose and post dose timepoints in Part B and Part C.
Incidence and severity of TEAE as assessed by the CTCAE in Part B and Part C. Week 52 Secondary endpoint in Part B and Part C
Trial Locations
- Locations (36)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
GCP Research
🇺🇸Saint Petersburg, Florida, United States
Agile Clinical Research Trials
🇺🇸Sandy Springs, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Sneeze, Wheeze & Itch Associates, LLC
🇺🇸Normal, Illinois, United States
Indiana University Health University Hospital
🇺🇸Indianapolis, Indiana, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Prism Research LLC dba Nucleus Network
🇺🇸Saint Paul, Minnesota, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Quality Clinical Research
🇺🇸Omaha, Nebraska, United States
Celiac Disease Center at Columbia University
🇺🇸New York, New York, United States
North Carolina Clinical Research
🇺🇸Raleigh, North Carolina, United States
Aventiv Research, Inc. d/b/a Centricity Research
🇺🇸Columbus, Ohio, United States
Great Lakes Gastroenterology Research, LLC
🇺🇸Mentor, Ohio, United States
Northshore Gastroenterology Research, LLC
🇺🇸Westlake, Ohio, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Digestive Research of Central Texas
🇺🇸Waco, Texas, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
P3 Research - Tauranga
🇳🇿Tauranga, Bay Of Plenty, New Zealand
P3 Research - Dunedin
🇳🇿Dunedin, Otago, New Zealand
P3 Research - Palmerston North
🇳🇿Paraparaumu, Wellington, New Zealand
Optimal Clinical Trials
🇳🇿Auckland, New Zealand
Velocity Clinical Research, Salt Lake City
🇺🇸West Jordan, Utah, United States
Campbelltown Hospital
🇦🇺Campbelltown, New South Wales, Australia
Wesley Research Institute
🇦🇺Auchenflower, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
The Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
St John of God Midland Public and Private Hospitals
🇦🇺Midland, Western Australia, Australia
PCRN Trials
🇳🇿Takapuna, Auckland, New Zealand
Waikato Hospital
🇳🇿Hamilton, New Zealand
P3 Research - Wellington
🇳🇿Wellington, New Zealand