drugset

drugset / Trial / NCT03585478

Latiglutenase as a Treatment for Celiac Disease

NCT03585478 ↗

Phase 2 Completed 79 enrolled Immunogenics, LLC National Center for Complementary and Integrative Health (NCCIH) · collab National Institutes of Health (NIH) · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

Single Center, Randomized, Double-Blind, Placebo Controlled, Gluten Challenge Trial in Patients with Well-Controlled Celiac Disease

Timeline

Start: 2019-03-01
Primary completion: 2021-01-22
Completion: 2021-01-22

Publications

Murray JA, Syage JA, Wu TT, Dickason MA, Ramos AG, Van Dyke C, Horwath I, Lavin PT, Maki M, Hujoel I, Papadakis KA, Bledsoe AC, Khosla C, Sealey-Voyksner JA; CeliacShield Study Group. Latiglutenase Protects the Mucosa and Attenuates Symptom Severity in Patients With Celiac Disease Exposed to a Gluten Challenge. Gastroenterology. 2022 Dec;163(6):1510-1521.e6. doi: 10.1053/j.gastro.2022.07.071. Epub 2022 Aug 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Latiglutenase	Protein / enzyme biologic	1200 mg	Oral

Indications