A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis

Summary

The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis.

Timeline

Start

2019-05-13

Primary completion

2020-02-20

Completion

2020-07-15

Outcome

Met primary endpoint

registry analysis (superiority test); Risankizumab vs Placebo; p <0.001; Mean Difference 59.0 (95% CI 48.4 to 69.6); Chi-squared NCT03875482 ↗

registry analysis (superiority test); Risankizumab vs Placebo; p <0.001; Mean Difference 68.5 (95% CI 57.2 to 79.7); Chi-squared NCT03875482 ↗

Publications

• Blauvelt A, Gordon KB, Lee P, Bagel J, Sofen H, Lockshin B, Soliman AM, Geng Z, Zhan T, Alperovich G, Stein Gold L. Efficacy, safety, usability, and acceptability of risankizumab 150 mg formulation administered by prefilled syringe or by an autoinjector for moderate to severe plaque psoriasis. J Dermatolog Treat. 2022 Jun;33(4):2085-2093. doi: 10.1080/09546634.2021.1914812. Epub 2021 May 5.

Drugs

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

Indications