drugset / Trial / NCT01483599
A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis
RandomizedParallel-groupTriple-blindTreatment
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
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 |