A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease

Summary

The primary objective of the study was to investigate long-term safety of risankizumab (BI 655066/ABBV-066) in participants with moderately to severely active Crohn's disease who showed a clinical response or remission on previous treatment with risankizumab in Study NCT02031276 (BI trial 1311.6/ AbbVie M15-993) and were now receiving long-term treatment. Additional objectives of this study were to further investigate long-term efficacy, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of risankizumab.

Timeline

Start

2015-09-16

Primary completion

2019-06-19

Completion

2019-06-19

Publications

• Ferrante M, Feagan BG, Panes J, Baert F, Louis E, Dewit O, Kaser A, Duan WR, Pang Y, Lee WJ, Gustafson D, Liao X, Wallace K, Kalabic J, D'Haens GR. Long-Term Safety and Efficacy of Risankizumab Treatment in Patients with Crohn's Disease: Results from the Phase 2 Open-Label Extension Study. J Crohns Colitis. 2021 Dec 18;15(12):2001-2010. doi: 10.1093/ecco-jcc/jjab093.

Drugs

Indications