Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease

Phase 2 Completed 254 enrolled Amgen

RandomizedParallel-groupTriple-blindTreatment

Summary

The primary objective of this study is to evaluate the efficacy of abrilumab as measured by the proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission (CDAI \< 150) after treatment for 8 weeks.

Timeline

Start: 2012-12-04
Primary completion: 2014-12-26
Completion: 2018-04-10

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Abrilumab 70 mg Q4W; p = 0.76; Odds Ratio (OR) 1.15 (90% CI 0.54 to 2.44); Regression, Logistic NCT01696396 ↗

registry analysis (superiority test); Placebo vs Abrilumab 210 mg; p = 0.22; Odds Ratio (OR) 1.91 (90% CI 0.80 to 4.57); Regression, Logistic NCT01696396 ↗

registry analysis (superiority test); Placebo vs Abrilumab 21 mg Q4W; p = 0.25; Odds Ratio (OR) 2.05 (90% CI 0.74 to 5.73); Regression, Logistic NCT01696396 ↗

Publications

Background Dummer R, Hoeller C, Gruter IP, Michielin O. Combining talimogene laherparepvec with immunotherapies in melanoma and other solid tumors. Cancer Immunol Immunother. 2017 Jun;66(6):683-695. doi: 10.1007/s00262-017-1967-1. Epub 2017 Feb 25.

Drugs

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