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

Phase 1

Recruiting

• Conditions: celiac disease; MedDRA version: 20.0Level: LLTClassification code: 10007864Term: Celiac disease Class: 10017947; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2023-507240-37-00
• Lead Sponsor: Kanyos Bio Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-27
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Adults aged 18 to 70 years inclusive., Previously documented diagnosis of CeD based on positive serology (eg, tissue transglutaminase IgA antibody and/or DGP IgG) AND intestinal histology consistent with = Marsh Type II or with evidence of villous atrophy., HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygotes or heterozygotes)., Negative or weak positive for transglutaminase IgA and negative or weak positive for DGP-IgA/IgG during screening., Have followed a gluten-free diet for =12 months immediately prior to study entry (self-reported)., Screening intestinal biopsy demonstrating Vh:Cd ratio of 2.3 or higher.

Exclusion Criteria

Refractory CeD, defined as severe persistent or recurrent malabsorptive signs or symptoms with substantial villous atrophy (eg, documented Marsh score 3c in source data) despite strict adherence to a GFD for at least 12 months in absence of other disorders., Previous treatment with tolerance-inducing therapies for CeD., Selective IgA deficiency., Positive for HLA-DQ8 genotype (DQA1*03, DQB1*0302) even if DQ2.5 is also present., Known wheat allergy., Diagnosis of type-I diabetes., History of dermatitis herpetiformis., Pregnant or breastfeeding., Known history of severe hypersensitivity reactions or anaphylaxis to gluten., Active gastrointestinal disease other than CeD (eg, inflammatory bowel disease, any forms of colitis except well-controlled microscopic colitis, uncontrolled IBS, peptic ulcer disease, eosinophilic esophagitis, and active GI infections).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess the ability of KAN-101 to attenuate gluten challenge (GC)-induced changes in duodenal histology as measured by changes in villus-height:crypt depth (Vh:Cd) ratio after a 2-week GC.;Secondary Objective: Examine the impact of KAN-101 on biomarker response (interleukin-2 [IL-2]) in peripheral blood following GC., Determine the effects of KAN-101 on histologic features (intraepithelial lymphocytes [IELs] density) in duodenum biopsies following 2-week GC., Assess the safety and tolerability of KAN-101 in participants with CeD., Assess the pharmacokinetics (PK) of multiple doses of KAN-101 in participants with CeD.;Primary end point(s): Changes from baseline in Vh:Cd ratio as assessed by esophagogastroduodenoscopy (EGD) with biopsy after 2-week GC (at Day 29).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):IL-2 change from Day 15 (first day of GC) pre GC to Day 15 post GC.;Secondary end point(s):Changes from baseline in IEL density in duodenum biopsy after 2-week GC (at Day 29).;Secondary end point(s):•Incidence and severity of treatment emergent AEs as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v6.0 (or higher). •Incidence and titer of KAN-101 anti-drug antibodies (ADA).;Secondary end point(s):Plasma concentration of KAN-101, and associated KAN-101 parameters: AUCinf, AUClast, Cmax, Tmax and t½.