A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Celiac Disease, Coeliac Disease

In brief

The study goal is to evaluate the efficacy, safety, and tolerability of KAN-101 in participants with Celiac Disease (CeD)

Key facts

Study ID

NCT06001177

Run by

Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA

People needed

55

Starts

2023-12-13

Expected to finish

2025-01-13

Last updated by the study team

2025-12-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Screening intestinal biopsy demonstrating Vh:Cd ratio of 2.3 or higher

You may not qualify if…

• Refractory celiac disease
• HLA-DQ8 genotype
• Selective IgA deficiency
• Diagnosis of type-I diabetes
• Other Active gastrointestinal diseases
• History of dermatitis herpetiformis

Where it is running

• 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

Full record on ClinicalTrials.gov

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