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

NCT06001177

CompletedPhase 2

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

Conditions: Celiac Disease, Coeliac Disease

Interventions: KAN-101, Placebo

Countries: United States, Canada, Finland, Germany, Ireland, Israel, Netherlands, Poland

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

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* Refractory celiac disease
* HLA-DQ8 genotype
* Selective IgA deficiency
* Diagnosis of type-I diabetes
* Other Active gastrointestinal diseases
* History of dermatitis herpetiformis
Locations (28)
  • Colorado Springs, Colorado, United States
  • Hialeah Gardens, Florida, United States
  • Miami, Florida, United States
  • Wichita, Kansas, United States
  • New Orleans, Louisiana, United States
  • Boston, Massachusetts, United States
  • Hamilton, Ontario, Canada
  • London, Ontario, Canada
  • Lévis, Quebec, Canada
  • Montreal, Quebec, Canada
  • Québec, Quebec, Canada
  • Tampere, Pirkanmaa, Finland
  • Turku, Southwest Finland, Finland
  • Helsinki, Uusimaa, Finland
  • Halle, Saxony-Anhalt, Germany
  • Dublin, Dublin, Ireland
  • Drogheda, Louth, Ireland
  • Mullingar, Westmeath, Ireland
  • Petah Tikva, Central District, Israel
  • Ramat Gan, Central District, Israel
  • Jerusalem, Jerusalem, Israel
  • Beersheba, Southern District, Israel
  • Dordrecht, South Holland, Netherlands
  • Torun, Kuyavian-Pomeranian Voivodeship, Poland
  • Wroclaw, Lower Silesian Voivodeship, Poland
  • Warsaw, Masovian Voivodeship, Poland
  • Knurów, Silesian Voivodeship, Poland
  • Lodz, Łódź Voivodeship, Poland