A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis Naive to Systemic Treatment

Phase 3 Completed 162 enrolled Eli Lilly and Company

RandomizedParallel-groupSingle-blindTreatment

Summary

The main purpose of this study is to evaluate the efficacy of ixekizumab compared to fumaric acid esters (FAE) and methotrexate (MTX) in participants with moderate-to-severe plaque psoriasis who are naive to systemic treatment.

Timeline

Start: 2016-01-20
Primary completion: 2016-11-29
Completion: 2017-11-14

Outcome

Met primary endpoint

registry analysis (unspecified test); Ixekizumab vs Fumaric Acid Esters; p <.0001; Risk Ratio (RR) 4.08 (95% CI 2.46 to 6.77); Fisher Exact NCT02634801 ↗

registry analysis (unspecified test); Ixekizumab vs Methotrexate; p = 0.0137; Risk Ratio (RR) 1.29 (95% CI 1.06 to 1.56); Fisher Exact NCT02634801 ↗

Publications

Reich K, Augustin M, Thaci D, Pinter A, Leutz A, Henneges C, Schneider E, Schacht A, Dossenbach M, Mrowietz U. A 24-week multicentre, randomized, open-label, parallel-group study comparing the efficacy and safety of ixekizumab vs. fumaric acid esters and methotrexate in patients with moderate-to-severe plaque psoriasis naive to systemic treatment. Br J Dermatol. 2020 Apr;182(4):869-879. doi: 10.1111/bjd.18384. Epub 2019 Nov 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ixekizumab	Monoclonal antibody	80 mg	Subcutaneous
Comparator	Methotrexate	Small molecule	30 mg	Oral