A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis

Summary

The purpose of this study is to evaluate the efficacy and safety of CNTO 1959 in the treatment of patients with moderate to severe plaque psoriasis.

Timeline

Start

2011-11-10

Primary completion

2012-11-27

Completion

2013-08-05

Outcome

Met primary endpoint

paper was significantly higher in each guselkumab group than in the placebo group: 34% in the 5-mg group, 61% in the 15-mg group PMID 26154787 ↗

registry analysis (superiority or other test); Placebo vs CNTO1959 5 mg; p = 0.002; Cochran-Mantel-Haenszel chi-square test NCT01483599 ↗

registry analysis (superiority or other test); Placebo vs CNTO1959 15 mg; p < 0.001; Cochran-Mantel-Haenszel chi-square test NCT01483599 ↗

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.
• Gordon KB, Duffin KC, Bissonnette R, Prinz JC, Wasfi Y, Li S, Shen YK, Szapary P, Randazzo B, Reich K. A Phase 2 Trial of Guselkumab versus Adalimumab for Plaque Psoriasis. N Engl J Med. 2015 Jul 9;373(2):136-44. doi: 10.1056/NEJMoa1501646.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Adalimumab	Monoclonal antibody	40 mg	Subcutaneous
Subject	Guselkumab	Monoclonal antibody	5 mg	Subcutaneous
Subject	Guselkumab	Monoclonal antibody	15 mg	Subcutaneous
Subject	Guselkumab	Monoclonal antibody	50 mg	Subcutaneous
Subject	Guselkumab	Monoclonal antibody	100 mg	Subcutaneous
Subject	Guselkumab	Monoclonal antibody	200 mg	Subcutaneous

Indications