Larazotide acetate — clinical evidence
Assessed outcomes with certainty ratings, contributing trials and the reasoning for each rating.
§3Clinical evidence
§3.1Inflammatory bowel disease and mucosal barrier disorders
Anchor outcome. Clinical remission.
Effect as recorded. A phase 2b trial met its primary endpoint on symptom scores at the 0.5 mg dose; the subsequent phase 3 trial was discontinued for futility at interim analysis; phase 2b positive; phase 3 futility.[1,2]
Certainty. Moderate certainty The Institute rates this moderate certainty for the conclusion that larazotide does not provide clinically meaningful benefit in coeliac disease at the doses studied. A positive phase 2b followed by a phase 3 futility stop is a textbook illustration of why phase 2 results should not be treated as conclusive, and the Institute cites this programme in its methodology documentation for that reason.
Contributing trials. CELIAC-PH2B · CELIAC-PH3-CEDLARA. Full structured abstracts are published for each.
Full evidence extract for inflammatory bowel disease and mucosal barrier disorders · Indication assessment
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
- Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, Cates CJ, Cheng HY, Corbett MS, Eldridge SM, Emberson JR, Hernán MA, Hopewell S, Hróbjartsson A, Junqueira DR, Jüni P, Kirkham JJ, Lasserson T, Li T, McAleenan A. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ 2019;366:l4898. doi:10.1136/bmj.l4898 · PMID 31462531
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.