Safety and Efficacy of Varying Methods of ALV003 Administration for the Treatment of Celiac Disease

NCT01255696 ↗

Phase 2 Completed 61 enrolled Alvine Pharmaceuticals Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.

Timeline

Start: 2010-11
Primary completion: 2011-05
Completion: 2011-06

Outcome

Met primary endpoint

paper Between groups, morphologic changes and CD3(+) intraepithelial lymphocyte counts differed significantly from baseline to week 6 (P = .0133 and P = .0123, respectively). PMID 24583059 ↗

Publications

Lahdeaho ML, Kaukinen K, Laurila K, Vuotikka P, Koivurova OP, Karja-Lahdensuu T, Marcantonio A, Adelman DC, Maki M. Glutenase ALV003 attenuates gluten-induced mucosal injury in patients with celiac disease. Gastroenterology. 2014 Jun;146(7):1649-58. doi: 10.1053/j.gastro.2014.02.031. Epub 2014 Feb 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Latiglutenase	Protein / enzyme biologic	—	Oral