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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Biotech, Inc.
ClinicalTrials.gov Identifier:
NCT01550744
First received: March 8, 2012
Last updated: June 16, 2014
Last verified: June 2014

March 8, 2012
June 16, 2014
March 2012
May 2015   (final data collection date for primary outcome measure)
The number of visits for which subjects achieve a physician global assessment (PGA) response as defined by minimal or clear disease [ Time Frame: Week 88 to Week 112 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01550744 on ClinicalTrials.gov Archive Site
  • PGA response over time as defined by minimal or clear disease [ Time Frame: Week 28 to Week 112 ] [ Designated as safety issue: No ]
    PGA response is defined by minimal or clear disease.
  • Psoriasis Area Severity Index (PASI) response over time [ Time Frame: Week 28 or Week 88 to Week 112 ] [ Designated as safety issue: No ]
    A PASI 75 response is defined as ≥ 75% improvement in PASI score from baseline.
Same as current
Not Provided
Not Provided
 
A Study of Ustekinumab to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
  • Drug: Ustekinumab 45 mg
    Form = Injection, route = subcutaneous
  • Drug: Ustekinumab 90 mg
    Form = Injection, route = subcutaneous
  • Drug: Placebo
    Form = Injection, route = subcutaneous
  • Experimental: Group 1: Approved q12w maintenance regimen
    Active ustekinumab study agent q12 weeks with sham/placebo as necessary to maintain blind
    Interventions:
    • Drug: Ustekinumab 45 mg
    • Drug: Ustekinumab 90 mg
    • Drug: Placebo
  • Experimental: Group 2: Subject-tailored fixed-interval maintenance regimen
    Subjects will undergo placebo withdrawal and will receive active study agent up to q24w intervals with sham/placebo injections to maintain the blind.
    Interventions:
    • Drug: Ustekinumab 45 mg
    • Drug: Ustekinumab 90 mg
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
479
July 2015
May 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01550744
CR100708, CNTO1275PSO3009
Yes
Janssen Biotech, Inc.
Janssen Biotech, Inc.
Not Provided
Study Director: Janssen Biotech, Inc. Clinical Trial Janssen Biotech, Inc.
Janssen Biotech, Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP