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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: Ustekinumab 90 mg; Drug: Ustekinumab 45 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01550744

CNTO1275PSO3009 (Other Identifier)

CR100708

Details and patient eligibility

About

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.

Full 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.

Enrollment: 478 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

478 participants in 2 patient groups

Group 1: Approved q12w maintenance regimen

Experimental group

Description:

Active ustekinumab study agent q12 weeks with sham/placebo as necessary to maintain blind

Treatment:

Drug: Placebo

Drug: Ustekinumab 90 mg

Drug: Ustekinumab 45 mg

Group 2: Subject-tailored fixed-interval maintenance regimen

Experimental group

Description:

Subjects will undergo placebo withdrawal and will receive active study agent up to q24w intervals with sham/placebo injections to maintain the blind.

Treatment:

Drug: Placebo

Drug: Ustekinumab 90 mg

Drug: Ustekinumab 45 mg