Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis

Summary

The purpose of the study is to evaluate the efficacy, safety, pharmacokinetics, immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device in participants with moderate to severe plaque-type psoriasis.

Timeline

Start

2017-02-28

Primary completion

2018-02-06

Completion

2018-02-06

Outcome

Met primary endpoint

registry NUMBER Placebo: 0 Percentage of participants NUMBER Guselkumab: 80.6 Percentage of participants analysis (superiority test); Placebo vs Guselkumab; p <0.001; Fisher Exact NCT02905331 ↗

registry NUMBER Placebo: 0 Percentage of participants NUMBER Guselkumab: 75.8 Percentage of participants analysis (superiority test); Placebo vs Guselkumab; p < 0.001; Fisher Exact NCT02905331 ↗

Publications

• Strober B, Coates LC, Lebwohl MG, Deodhar A, Leibowitz E, Rowland K, Kollmeier AP, Miller M, Wang Y, Li S, Chakravarty SD, Chan D, Shawi M, Yang YW, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Saf. 2024 Jan;47(1):39-57. doi: 10.1007/s40264-023-01361-w. Epub 2023 Oct 31.
• Ferris LK, Ott E, Jiang J, Hong HC, Li S, Han C, Baran W. Efficacy and safety of guselkumab, administered with a novel patient-controlled injector (One-Press), for moderate-to-severe psoriasis: results from the phase 3 ORION study. J Dermatolog Treat. 2020 Mar;31(2):152-159. doi: 10.1080/09546634.2019.1587145. Epub 2019 Mar 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Guselkumab	Monoclonal antibody	100 mg	Subcutaneous

Indications