A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)
NCT ID: NCT05574010
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1/PHASE2
126 participants
INTERVENTIONAL
2022-11-15
2025-05-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assessment of KAN-101 in Celiac Disease (ACeD)
NCT04248855
A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease
NCT06001177
Safety and Systemic Exposure Study of BL-7010 in Well-Controlled Celiac Patients.
NCT01990885
Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients
NCT04243551
Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease
NCT00492960
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
Part B and Part C: These parts of the study have a randomized, double- blinded, placebo-controlled, parallel study design.
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1 in Part A
All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 1
Cohort 1 in Part A
Dose 1 KAN-101 Intravenous (IV) infusion
Cohort 2 in Part A
All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 2
Cohort 2 in Part A
Dose 2 KAN-101 Intravenous (IV) infusion
Group 1 in Part B and Part C
All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of placebo
Placebo: Group 1 in Part B and Part C
Placebo Intravenous (IV) infusion
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
Group 2 in Part B and Part C
Dose 3 KAN-101 Intravenous (IV) infusion
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 3 in Part B and Part C
Dose 4 KAN-101 Intravenous (IV) infusion
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
Group 4 in Part B and Part C
Dose 5 KAN-101 Intravenous (IV) infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cohort 1 in Part A
Dose 1 KAN-101 Intravenous (IV) infusion
Cohort 2 in Part A
Dose 2 KAN-101 Intravenous (IV) infusion
Placebo: Group 1 in Part B and Part C
Placebo Intravenous (IV) infusion
Group 2 in Part B and Part C
Dose 3 KAN-101 Intravenous (IV) infusion
Group 3 in Part B and Part C
Dose 4 KAN-101 Intravenous (IV) infusion
Group 4 in Part B and Part C
Dose 5 KAN-101 Intravenous (IV) infusion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
Anokion SA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
GCP Research
St. 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
St 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
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
P3 Research - Tauranga
Tauranga, Bay of Plenty, New Zealand
P3 Research - Dunedin
Dunedin, Otago, New Zealand
P3 Research - Palmerston North
Paraparaumu, Wellington Region, New Zealand
Optimal Clinical Trials
Auckland, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
P3 Research - Wellington
Wellington, , New Zealand
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Murray JA, Wassaf D, Dunn K, Arora S, Winkle P, Stacey H, Cooper S, Goldstein KE, Manchanda R, Kontos S, Grebe KM. Safety and tolerability of KAN-101, a liver-targeted immune tolerance therapy, in patients with coeliac disease (ACeD): a phase 1 trial. Lancet Gastroenterol Hepatol. 2023 Aug;8(8):735-747. doi: 10.1016/S2468-1253(23)00107-3. Epub 2023 Jun 14.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KAN-101-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.