A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease
NCT ID: NCT06001177
Last Updated: 2025-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
55 participants
INTERVENTIONAL
2023-12-13
2025-01-13
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group 1
All eligible participants will receive 3 intravenous (IV) infusions of KAN-101
KAN-101
Dose KAN-101 Intravenous (IV) Infusion
Group 2
All eligible participants will receive 3 intravenous (IV) infusions of placebo
Placebo
Placebo Intravenous (IV) Infusion
Interventions
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KAN-101
Dose KAN-101 Intravenous (IV) Infusion
Placebo
Placebo Intravenous (IV) Infusion
Other Intervention Names
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Eligibility Criteria
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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
* Screening intestinal biopsy demonstrating Vh:Cd ratio of 2.3 or higher
Exclusion Criteria
* HLA-DQ8 genotype
* Selective IgA deficiency
* Diagnosis of type-I diabetes
* Other Active gastrointestinal diseases
* History of dermatitis herpetiformis
18 Years
70 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Anokion SA
Locations
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Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Unlimited Medical Research Group
Hialeah Gardens, Florida, United States
Homestead Associates in Research Inc.
Miami, Florida, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
McMaster University
Hamilton, Ontario, Canada
LHSC
London, Ontario, Canada
Centre Intégré de Santé et de Services Sociaux-Chaudière Appalaches - Hôtel-Dieu de Lévis
Lévis, Quebec, Canada
Hopital Du Sacre-Coeur De Montreal
Montreal, Quebec, Canada
Diex Recherche Quebec Inc.
Québec, Quebec, Canada
Tays Research Services
Tampere, Pirkanmaa, Finland
Clinical Research Services Turku
Turku, Southwest Finland, Finland
CRST Helsinki Oy
Helsinki, Uusimaa, Finland
Studiengesellschaft BSF Unternehmergesellschaft
Halle, Saxony-Anhalt, Germany
Connolly Hospital
Dublin, Dublin, Ireland
Our Lady of Lourdes Hospital
Drogheda, Louth, Ireland
Midland Regional Hospital Mullingar
Mullingar, Westmeath, Ireland
Rabin Medical Center
Petah Tikva, Central District, Israel
Sheba Medical Center
Ramat Gan, Central District, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Soroka Medical Center
Beersheba, Southern District, Israel
Albert Schweitzer Ziekenhuis, locatie Dordwijk
Dordrecht, South Holland, Netherlands
Gastromed Sp. z o. o.
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Melita Medical
Wroclaw, Lower Silesian Voivodeship, Poland
WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Masovian Voivodeship, Poland
MZ Badania Slowik Zymla Spolka Jawna
Knurów, Silesian Voivodeship, Poland
Centrum Medyczne Med-Gastr Sp. z o.o.
Lodz, Łódź Voivodeship, Poland
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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KAN-101-03
Identifier Type: -
Identifier Source: org_study_id