Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis

Summary

The primary objective of this study is to evaluate the effect of abrilumab on induction of remission in adults with moderate to severe ulcerative colitis after 8 weeks of treatment as assessed by a total Mayo Score ≤ 2 points, with no individual subscore \> 1 point.

Timeline

Start

2012-11-16

Primary completion

2015-07-13

Completion

2018-04-10

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Abrilumab 70 mg Q4W; p = 0.021; Odds Ratio (OR) 3.35 (90% CI 1.41 to 7.95); Regression, Logistic NCT01694485 ↗

registry analysis (superiority test); Placebo vs Abrilumab 210 mg; p = 0.030; Odds Ratio (OR) 3.33 (90% CI 1.34 to 8.26); Regression, Logistic NCT01694485 ↗

Publications

• Sandborn WJ, Cyrille M, Hansen MB, Feagan BG, Loftus EV Jr, Rogler G, Vermeire S, Cruz ML, Yang J, Boedigheimer MJ, Abuqayyas L, Evangelista CM, Sullivan BA, Reinisch W. Efficacy and Safety of Abrilumab in a Randomized, Placebo-Controlled Trial for Moderate-to-Severe Ulcerative Colitis. Gastroenterology. 2019 Mar;156(4):946-957.e18. doi: 10.1053/j.gastro.2018.11.035. Epub 2018 Nov 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abrilumab	Monoclonal antibody	7 mg	Subcutaneous
Subject	Abrilumab	Monoclonal antibody	21 mg	Subcutaneous
Subject	Abrilumab	Monoclonal antibody	70 mg	Subcutaneous
Subject	Abrilumab	Monoclonal antibody	210 mg	Subcutaneous

Indications