drugset

drugset / Trial / NCT06001177

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

NCT06001177 ↗

Phase 2 Completed 55 enrolled Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA Pfizer · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

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

Timeline

Start: 2023-12-13
Primary completion: 2025-01-03
Completion: 2025-01-13

Outcome

Missed primary endpoint

registry analysis (superiority test); 0.6 mg/kg KAN-101 vs Placebo; p = 0.1668 NCT06001177 ↗

Publications

Background 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	KAN-101	Peptide	—	Intravenous

Indications