A Randomized Trial of a Transglutaminase 2 Inhibitor for Celiac Disease

In a phase 2 proof-of-concept trial, patients with celiac disease controlled on a gluten-free diet were assigned to one of three dose levels of ZED1227 (a selective transglutaminase 2 inhibitor) or placebo. Patients were challenged with 3 g of gluten daily for 6 weeks. Comparison of duodenal-biopsy...

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Veröffentlicht in:	The New England journal of medicine 2021-07, Vol.385 (1), p.35-45
Hauptverfasser:	Schuppan, Detlef, Mäki, Markku, Lundin, Knut E.A, Isola, Jorma, Friesing-Sosnik, Tina, Taavela, Juha, Popp, Alina, Koskenpato, Jari, Langhorst, Jost, Hovde, Øistein, Lähdeaho, Marja-Leena, Fusco, Stefano, Schumann, Michael, Török, Helga P, Kupcinskas, Juozas, Zopf, Yurdagül, Lohse, Ansgar W, Scheinin, Mika, Kull, Karin, Biedermann, Luc, Byrnes, Valerie, Stallmach, Andreas, Jahnsen, Jørgen, Zeitz, Jonas, Mohrbacher, Ralf, Greinwald, Roland
Format:	Artikel
Sprache:	eng
Schlagworte:	Adverse events Allergy Atrophy Biopsy Celiac disease Diarrhea Diet Disease Dosage Drug dosages Endoscopy Epithelial cells Gastroenterology Gastroenterology General Glutamine Gluten Hyperplasia Immunology Immunology General Laboratories Lymphocytes Lymphocytes T Morphology Mucosa Nausea Nutrition Patients Peptides Placebos Quality of life Questionnaires Small intestine Transglutaminase 2 Villus Vomiting
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Beschreibung
Zusammenfassung:	In a phase 2 proof-of-concept trial, patients with celiac disease controlled on a gluten-free diet were assigned to one of three dose levels of ZED1227 (a selective transglutaminase 2 inhibitor) or placebo. Patients were challenged with 3 g of gluten daily for 6 weeks. Comparison of duodenal-biopsy samples between baseline and 6 weeks showed that ZED1227 attenuated gluten-induced mucosal damage.
ISSN:	0028-4793 1533-4406
DOI:	10.1056/NEJMoa2032441