Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

Phase 3 Completed 201 enrolled Eli Lilly and Company

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of ixekizumab in pediatric participants with moderate-to-severe plaque psoriasis.

Timeline

Start: 2017-03-28
Primary completion: 2019-02-07
Completion: 2021-03-23

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Ixekizumab; p <0.001; Mean Difference (Final Values) 63.7 (95% CI 51.0 to 76.4); Fisher Exact NCT03073200 ↗

registry analysis (superiority test); Placebo vs Ixekizumab; p <0.001; Mean Difference (Final Values) 70.2 (95% CI 59.3 to 81); Fisher Exact NCT03073200 ↗

release “Taltz met co-primary endpoints as well as all major secondary endpoints in a Phase 3 study in pediatric patients with moderate to severe plaque psoriasis” lilly.com ↗

Publications

Paller AS, Seyger MMB, Magarinos GA, Pinter A, Cather JC, Rodriguez-Capriles C, Zhu D, Somani N, Garrelts A, Papp KA; IXORA-PEDS Investigators. Long-term Efficacy and Safety of Up to 108 Weeks of Ixekizumab in Pediatric Patients With Moderate to Severe Plaque Psoriasis: The IXORA-PEDS Randomized Clinical Trial. JAMA Dermatol. 2022 May 1;158(5):533-541. doi: 10.1001/jamadermatol.2022.0655.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etanercept	Protein / enzyme biologic	—	Subcutaneous
Subject	Ixekizumab	Monoclonal antibody	—	Subcutaneous