A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)

Phase 3 Completed 1484 enrolled Eli Lilly and Company

RandomizedParallel-groupDouble-blindTreatment

Summary

The reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for moderate to severe plaque psoriasis.

Timeline

Start: 2018-06-26
Primary completion: 2020-03-05
Completion: 2020-06-03

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs 250mg Q4W Mirikizumab; p <0.001; Risk Difference (RD) 73.5 (95% CI 68.2 to 78.7) NCT03535194 ↗

registry analysis (superiority test); Placebo vs 250mg Q4W Mirikizumab; p <0.001; Risk Difference (RD) 68.0 (95% CI 62.7 to 73.3) NCT03535194 ↗

release “mirikizumab met the primary and all key secondary endpoints in a phase 3 study comparing the efficacy and safety of mirikizumab to placebo and Cosentyx®” lilly.com ↗

Publications

Papp K, Warren RB, Green L, Reich K, Langley RG, Paul C, Asahina A, Johnson L, Arora V, Osuntokun O, Lebwohl M. Safety and efficacy of mirikizumab versus secukinumab and placebo in the treatment of moderate-to-severe plaque psoriasis (OASIS-2): a phase 3, multicentre, randomised, double-blind study. Lancet Rheumatol. 2023 Sep;5(9):e542-e552. doi: 10.1016/S2665-9913(23)00120-0. Epub 2023 Aug 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirikizumab	Monoclonal antibody	125 mg	Subcutaneous
Subject	Mirikizumab	Monoclonal antibody	250 mg	Subcutaneous
Comparator	Secukinumab	Monoclonal antibody	300 mg	Subcutaneous