A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis

Phase 2 Completed 172 enrolled AbbVie

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to assess the safety and efficacy of risankizumab for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents.

Timeline

Start: 2018-12-27
Primary completion: 2020-10-28
Completion: 2021-04-26

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Risankizumab 150 mg; p = 0.084; Adjusted Difference 13.0 (95% CI -1.7 to 27.7); Cochran-Mantel-Haenszel NCT03706040 ↗

paper The study's primary endpoint was not met, with no significant difference in the proportion of patients achieving an EASI 75 response at week 16 with risankizumab 150 mg or 300 mg versus placebo. PMID 36588137 ↗

Publications

Tyring SK, Rich P, Tada Y, Beeck S, Messina I, Liu J, Huang X, Shumack S. Risankizumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study. Dermatol Ther (Heidelb). 2023 Feb;13(2):595-608. doi: 10.1007/s13555-022-00876-x. Epub 2023 Jan 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Risankizumab	Monoclonal antibody	150 mg	Subcutaneous
Subject	Risankizumab	Monoclonal antibody	300 mg	Subcutaneous