drugset / Trial / NCT01550744
A Study of Ustekinumab to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of the study is to assess the effect of extending maintenance dosing intervals beyond 12 weeks on the clinical efficacy and safety of ustekinumab in subjects with moderate-to-severe plaque psoriasis.
Timeline
- Start
- 2012-03
- Primary completion
- 2015-05
- Completion
- 2015-07
Publications
- Loesche MA, Farahi K, Capone K, Fakharzadeh S, Blauvelt A, Duffin KC, DePrimo SE, Munoz-Elias EJ, Brodmerkel C, Dasgupta B, Chevrier M, Smith K, Horwinski J, Tyldsley A, Grice EA. Longitudinal Study of the Psoriasis-Associated Skin Microbiome during Therapy with Ustekinumab in a Randomized Phase 3b Clinical Trial. J Invest Dermatol. 2018 Sep;138(9):1973-1981. doi: 10.1016/j.jid.2018.03.1501. Epub 2018 Mar 17.
- Blauvelt A, Ferris LK, Yamauchi PS, Qureshi A, Leonardi CL, Farahi K, Fakharzadeh S, Hsu MC, Li S, Chevrier M, Smith K, Goyal K, Chen Y, Munoz-Elias EJ, Callis Duffin K. Extension of ustekinumab maintenance dosing interval in moderate-to-severe psoriasis: results of a phase IIIb, randomized, double-blinded, active-controlled, multicentre study (PSTELLAR). Br J Dermatol. 2017 Dec;177(6):1552-1561. doi: 10.1111/bjd.15722. Epub 2017 Nov 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ustekinumab | Monoclonal antibody | 45 mg | Subcutaneous |
| Subject | Ustekinumab | Monoclonal antibody | 90 mg | Subcutaneous |