drugset / Trial / NCT02207231
A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis.
Timeline
- Start
- 2014-11-26
- Primary completion
- 2015-09-29
- Completion
- 2020-06-17
Outcome
Met primary endpoint
registry NUMBER Placebo: 6.9 percentage of participants NUMBER Guselkumab: 85.1 percentage of participants analysis (unspecified test); Placebo vs Guselkumab; p <0.001 NCT02207231 ↗
registry NUMBER Placebo: 2.9 percentage of participants NUMBER Guselkumab: 73.3 percentage of participants analysis (unspecified test); Placebo vs Guselkumab; p <0.001 NCT02207231 ↗
Publications
- Puig L, Costanzo A, de Jong EMGJ, Torres T, Warren RB, Wapenaar R, Wegner S, Gorecki P, Gramiccia T, Jazra M, Buyze J, Conrad C. Progression of Quality of Life in Patients with Plaque Psoriasis Who Achieved Three or More Years of Complete Skin Clearance with Guselkumab Treatment: a Post hoc Analysis of the VOYAGE 1 Clinical Trial. Dermatol Ther (Heidelb). 2024 Sep;14(9):2539-2558. doi: 10.1007/s13555-024-01245-6. Epub 2024 Aug 17.
- Blauvelt A, Langley RG, Branigan PJ, Liu X, Chen Y, DePrimo S, Ma K, Scott B, Campbell K, Munoz-Elias EJ, Papp KA. Guselkumab Reduces Disease- and Mechanism-Related Biomarkers More Than Adalimumab in Patients with Psoriasis: A VOYAGE 1 Substudy. JID Innov. 2024 Jun 5;4(5):100287. doi: 10.1016/j.xjidi.2024.100287. eCollection 2024 Sep.
- Egeberg A, Conrad C, Gorecki P, Wegner S, Buyze J, Acciarri L, Thaci D. Response Types and Factors Associated with Response Types to Biologic Therapies in Patients with Moderate-to-Severe Plaque Psoriasis from Two Randomized Clinical Trials. Dermatol Ther (Heidelb). 2024 Mar;14(3):745-758. doi: 10.1007/s13555-024-01123-1. Epub 2024 Mar 15.
- 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.
- Puig L, Costanzo A, de Jong EMGJ, Torres T, Warren RB, Wapenaar R, Wegner S, Gorecki P, Gramiccia T, Jazra M, Buyze J, Conrad C. Guselkumab-Treated Patients with Plaque Psoriasis Who Achieved Complete Skin Clearance for >/= 156 Consecutive Weeks: A Post-Hoc Analysis From the VOYAGE 1 Clinical Trial. Am J Clin Dermatol. 2024 Mar;25(2):315-325. doi: 10.1007/s40257-023-00816-1. Epub 2023 Oct 7.
- Kim BS, Jo SJ, Youn S, Reich K, Saadoun C, Chang CL, Yang YW, Huang YH, Tsai TF. Five-year Maintenance of Clinical Response and Consistent Safety Profile for Guselkumab in Asian patients with Psoriasis from VOYAGE 1 and VOYAGE 2. Dermatol Ther (Heidelb). 2023 Nov;13(11):2721-2737. doi: 10.1007/s13555-023-01026-7. Epub 2023 Sep 26.
- Orbai AM, Chakravarty SD, You Y, Shawi M, Yang YW, Merola JF. Efficacy of Guselkumab in Treating Nails, Scalp, Hands, and Feet in Patients with Psoriasis and Self-reported Psoriatic Arthritis. Dermatol Ther (Heidelb). 2023 Nov;13(11):2859-2868. doi: 10.1007/s13555-023-01012-z. Epub 2023 Sep 15.
- Reich K, Gordon KB, Strober BE, Armstrong AW, Miller M, Shen YK, You Y, Han C, Yang YW, Foley P, Griffiths CEM. Five-year maintenance of clinical response and health-related quality of life improvements in patients with moderate-to-severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2. Br J Dermatol. 2021 Dec;185(6):1146-1159. doi: 10.1111/bjd.20568. Epub 2021 Sep 8.
- Armstrong AW, Reich K, Foley P, Han C, Song M, Shen YK, You Y, Papp KA. Improvement in Patient-Reported Outcomes (Dermatology Life Quality Index and the Psoriasis Symptoms and Signs Diary) with Guselkumab in Moderate-to-Severe Plaque Psoriasis: Results from the Phase III VOYAGE 1 and VOYAGE 2 Studies. Am J Clin Dermatol. 2019 Feb;20(1):155-164. doi: 10.1007/s40257-018-0396-z.
- Foley P, Gordon K, Griffiths CEM, Wasfi Y, Randazzo B, Song M, Li S, Shen YK, Blauvelt A. Efficacy of Guselkumab Compared With Adalimumab and Placebo for Psoriasis in Specific Body Regions: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Dermatol. 2018 Jun 1;154(6):676-683. doi: 10.1001/jamadermatol.2018.0793.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |
| Subject | Guselkumab | Monoclonal antibody | 100 mg | Subcutaneous |