BI 655066 (Risankizumab) Proof of Concept Dose Finding Study in Ankylosing Spondylitis (AS)

NCT02047110 ↗

Phase 2 Completed 159 enrolled AbbVie Boehringer Ingelheim · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The overall purpose of the trial is to assess the clinical efficacy of three different subcutaneous doses of BI 655066 (risankizumab) in adult patients with AS, in order to provide clinical proof of concept and to select dose (s) for confirmatory clinical trials.

Timeline

Start: 2014-01-28
Primary completion: 2015-03-05
Completion: 2016-07-25

Outcome

Missed primary endpoint

registry Placebo vs Risankizumab 180 mg; p = 0.4243; Risk Difference (RD) -2.5 (90% CI -21.8 to 17.0) NCT02047110 ↗

paper Treatment with risankizumab did not meet the study primary endpoint PMID 29945918 ↗

Publications

Baeten D, Ostergaard M, Wei JC, Sieper J, Jarvinen P, Tam LS, Salvarani C, Kim TH, Solinger A, Datsenko Y, Pamulapati C, Visvanathan S, Hall DB, Aslanyan S, Scholl P, Padula SJ. Risankizumab, an IL-23 inhibitor, for ankylosing spondylitis: results of a randomised, double-blind, placebo-controlled, proof-of-concept, dose-finding phase 2 study. Ann Rheum Dis. 2018 Sep;77(9):1295-1302. doi: 10.1136/annrheumdis-2018-213328. Epub 2018 Jun 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Risankizumab	Monoclonal antibody	18 mg	Subcutaneous
Subject	Risankizumab	Monoclonal antibody	90 mg	Subcutaneous
Subject	Risankizumab	Monoclonal antibody	180 mg	Subcutaneous