Conditions: Psoriasis
Keywords: Psoriasis Ustekinumab STELARA Skin disease Monoclonal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 478
Healthy volunteers: no

Brief 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.

Detailed description:
In this study, a proportion of subjects will receive study agent at its recommended dose and interval (45mg for subjects less than or equal to 100kg, or 90mg for subjects greater than 100kg; every 12 weeks after 2 starter doses at Weeks 0 and 4). The majority of subjects will have the opportunity to receive study agent less frequently during the randomization period depending on the subject's response. The study consists of a 4-week screening period; a 28-week open-label run-in period; a double-blind treatment period from Week 28 to Week 104; a 12 week post-treatment period; and a 20-week safety follow-up. Participants will be randomized for the double blind period into one of two study groups. Group 1 participants will receive an injection of the study medication at a 12 week dosing interval. Group 2 participants will undergo a placebo withdrawal and may receive study agents at an extended interval greater than 12 weeks. During the double-blind treatment period, subjects in Groups 1 and 2 will receive placebo as necessary to maintain the blind.

Arms:
arm 1: Active ustekinumab study agent q12 weeks with sham/placebo as necessary to maintain blind arm 2: Subjects will undergo placebo withdrawal and will receive active study agent up to q24w intervals with sham/placebo injections to maintain the blind.

Interventions: intervention 1: Ustekinumab 45 mg intervention 2: Ustekinumab 90 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Form = Injection, route = subcutaneous intervention 2: Form = Injection, route = subcutaneous intervention 3: Form = Injection, route = subcutaneous

Protocol document: