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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)

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ClinicalTrials.gov Identifier: NCT01550744
Recruitment Status : Completed
First Posted : March 12, 2012
Results First Posted : November 7, 2016
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Biotech, Inc.

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Ustekinumab 45 mg Drug: Ustekinumab 90 mg Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 478 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2012
Primary Completion Date : May 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Ustekinumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group 1: Approved q12w maintenance regimen
Active ustekinumab study agent q12 weeks with sham/placebo as necessary to maintain blind
Drug: Ustekinumab 45 mg
Form = Injection, route = subcutaneous
Drug: Ustekinumab 90 mg
Form = Injection, route = subcutaneous
Drug: Placebo
Form = Injection, route = subcutaneous
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.
Drug: Ustekinumab 45 mg
Form = Injection, route = subcutaneous
Drug: Ustekinumab 90 mg
Form = Injection, route = subcutaneous
Drug: Placebo
Form = Injection, route = subcutaneous



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550744


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Sponsors and Collaborators
Janssen Biotech, Inc.
Investigators
Study Director: Janssen Biotech, Inc. Clinical Trial Janssen Biotech, Inc.

Responsible Party: Janssen Biotech, Inc.
ClinicalTrials.gov Identifier: NCT01550744     History of Changes
Other Study ID Numbers: CR100708
CNTO1275PSO3009 ( Other Identifier: Janssen Biotech, Inc )
First Posted: March 12, 2012    Key Record Dates
Results First Posted: November 7, 2016
Last Update Posted: February 9, 2017
Last Verified: December 2016

Keywords provided by Janssen Biotech, Inc.:
Psoriasis
Ustekinumab
STELARA
Skin disease
Monoclonal

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ustekinumab
Dermatologic Agents