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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Biotech, Inc.
ClinicalTrials.gov Identifier:
NCT01550744
First received: March 8, 2012
Last updated: December 15, 2016
Last verified: December 2016

March 8, 2012
December 15, 2016
March 2012
May 2015   (Final data collection date for primary outcome measure)
The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) [ Time Frame: Up to 24 weeks (Week 88 up to Week 112 [total 7 visits]) ]
Clinical responses for week (wk)28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe.
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 ]
Complete list of historical versions of study NCT01550744 on ClinicalTrials.gov Archive Site
  • The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time [ Time Frame: Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112 ]
    Clinical responses for week (wk) 28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe.
  • The Number of Visits for Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 75 Response [ Time Frame: Up to 24 weeks (Week 88 up to Week 112 [total 7 visits]) ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (>=) 75 percent (%) improvement in PASI score from baseline.
  • The Percentage of Participants With a PASI 75 Response Over Time [ Time Frame: Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112 ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (>=) 75 percent (%) improvement in PASI score from baseline.
  • PGA response over time as defined by minimal or clear disease [ Time Frame: Week 28 to Week 112 ]
    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 ]
    A PASI 75 response is defined as ≥ 75% improvement in PASI score from baseline.
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
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.
 
Completed
478
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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01550744
CR100708, CNTO1275PSO3009
Yes
Not Provided
Not Provided
Not Provided
Janssen Biotech, Inc.
Janssen Biotech, Inc.
Not Provided
Study Director: Janssen Biotech, Inc. Clinical Trial Janssen Biotech, Inc.
Janssen Biotech, Inc.
December 2016

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