A Study of Ustekinumab to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:March 2012
End Date:July 2015

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A Phase 3b, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis

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.

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.

Key Eligibility Criteria

- Male or female

- Have had a diagnosis of plaque-type psoriasis at least 6 months prior to the first
administration of study agent (subjects with concurrent psoriatic arthritis may be
enrolled).

- Have plaque-type psoriasis covering at least 10% of their total BSA at screening and
at the time of the first administration of study agent.

- Have a PGA score of ≥ 3 at screening and at the time of the first administration of
study agent.
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