Celiac Disease Clinical Trial
— SynCeDOfficial title:
A Phase 2a Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of KAN-101 In Participants With Celiac Disease
The study goal is to evaluate the efficacy, safety, and tolerability of KAN-101 in participants with Celiac Disease (CeD)
Status | Recruiting |
Enrollment | 52 |
Est. completion date | June 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Centre Intégré de Santé et de Services Sociaux-Chaudière Appalaches - Hôtel-Dieu de Lévis | Lévis | Quebec |
Canada | Hopital Du Sacre-Coeur De Montreal | Montréal | Quebec |
United States | Peak Gastroenterology Associates | Colorado Springs | Colorado |
United States | Unlimited Medical Research Group | Hialeah Gardens | Florida |
United States | Homestead Associates in Research Inc. | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA | Pfizer |
United States, Canada,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes from baseline in Vh:Cd as assessed by esophagogastroduodenoscopy with biopsy after 2-week gluten challenge (GC) | Vh:Cd is the ratio of villous height to crypt depth, a histological assessment | 29 days | |
Secondary | Change in magnitude of IL-2 response from Day 15 (first day of GC) pre GC to Day 15 post GC | IL-2 is interleukin-2 | 15 days | |
Secondary | Changes from baseline in IEL density in duodenum biopsy after 2-week GC | IEL is intraepithelial lymphocyte | 29 days | |
Secondary | Incidence and severity of treatment emergent adverse events as assessed by the CTCAE | Common Terminology Criteria for Adverse Events (CTCAE) is a scale with 5 grades to assess Adverse Event (AE) severity | 42 days | |
Secondary | Incidence of KAN-101 ADA | ADA is antidrug antibody | 42 days | |
Secondary | Titer of KAN-101 ADA | ADA is antidrug antibody | 42 days | |
Secondary | KAN-101 plasma concentration: AUCinf | Pharmacokinetic (PK) sample collection at pre and post dose timepoints | 7 days | |
Secondary | KAN-101 plasma concentration: AUClast | PK sample collection at pre and post dose timepoints | 7 days | |
Secondary | KAN-101 plasma concentration: Cmax | PK sample collection at pre and post dose timepoints | 7 days | |
Secondary | KAN-101 plasma concentration: Tmax | PK sample collection at pre and post dose timepoints | 7 days | |
Secondary | KAN-101 plasma concentration: T1/2 | PK sample collection at pre and post dose timepoints | 7 days |
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