TerminatedPhase 1/2

A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)

Stopped: Sponsor decision

United States128 participantsStarted 2022-11-15

Plain-language summary

This study is to evaluate the Pharmacodynamic (PD), safety, tolerability, Pharmacokinetic (PK), and plasma biomarker response of KAN-101 in participants with Celiac Disease (CeD).

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Exclusion Criteria: * Refractory celiac disease * HLA-DQ8 genotype * Previous oral gluten challenge within 12 months * Selective IgA deficiency * Diagnosis of Type-1 diabetes * Active gastrointestinal diseases * History of dermatitis herpetiformis

What they're measuring

Incidence and Severity of TEAEs as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) in Part A

Timeframe: From screening until the safety follow-up visit on Day 28

Change in Pre- and Post-Gluten Challenge (GC) IL-2 Response From Baseline to Day 15

Timeframe: From Baseline screening to Day 15

Change in IL-2 Response From Day 15 Pre-GC to Day 15 Post GC

Timeframe: 0 (pre-GC) and 4 hours post-GC on Day 15

Trial details

NCT IDNCT05574010

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-29

Results submitted2025-12-10

View on ClinicalTrials.gov More Celiac Disease trials