- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01550744
A Study of Ustekinumab to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis (PSTELLAR)
December 15, 2016 updated by: Janssen Biotech, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
478
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States
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California
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Bakersfield, California, United States
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Irvine, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Santa Monica, California, United States
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Colorado
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Denver, Colorado, United States
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Connecticut
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Bridgeport, Connecticut, United States
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Florida
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Coral Gables, Florida, United States
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St. Augustine, Florida, United States
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Tampa, Florida, United States
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Illinois
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Chicago, Illinois, United States
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Indiana
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Indianapolis, Indiana, United States
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Plainfield, Indiana, United States
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Kentucky
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Louisville, Kentucky, United States
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Louisiana
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New Orleans, Louisiana, United States
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Massachusetts
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Boston, Massachusetts, United States
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Michigan
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Troy, Michigan, United States
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Minnesota
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Fridley, Minnesota, United States
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Missouri
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Saint Louis, Missouri, United States
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Nevada
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Henderson, Nevada, United States
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New Hampshire
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Lebanon, New Hampshire, United States
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New Jersey
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East Windsor, New Jersey, United States
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New York
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Bronx, New York, United States
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New York, New York, United States
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Williamsville, New York, United States
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Ohio
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Gahanna, Ohio, United States
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Oklahoma
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Norman, Oklahoma, United States
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Oregon
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Portland, Oregon, United States
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Pennsylvania
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Pittsburgh, Pennsylvania, United States
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Yardley, Pennsylvania, United States
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Rhode Island
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Johnston, Rhode Island, United States
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Tennessee
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Nashville, Tennessee, United States
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Texas
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Arlington, Texas, United States
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Dallas, Texas, United States
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Utah
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Salt Lake City, Utah, United States
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Virginia
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Norfolk, Virginia, United States
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Washington
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Spokane, Washington, United States
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West Virginia
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Clarksburg, West Virginia, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Group 1: Approved q12w maintenance regimen
Active ustekinumab study agent q12 weeks with sham/placebo as necessary to maintain blind
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Form = Injection, route = subcutaneous
Form = Injection, route = subcutaneous
Form = Injection, route = subcutaneous
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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.
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Form = Injection, route = subcutaneous
Form = Injection, route = subcutaneous
Form = Injection, route = subcutaneous
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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])
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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.
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Up to 24 weeks (Week 88 up to Week 112 [total 7 visits])
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112
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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])
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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.
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Up to 24 weeks (Week 88 up to Week 112 [total 7 visits])
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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
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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.
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Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Loesche MA, Farahi K, Capone K, Fakharzadeh S, Blauvelt A, Duffin KC, DePrimo SE, Munoz-Elias EJ, Brodmerkel C, Dasgupta B, Chevrier M, Smith K, Horwinski J, Tyldsley A, Grice EA. Longitudinal Study of the Psoriasis-Associated Skin Microbiome during Therapy with Ustekinumab in a Randomized Phase 3b Clinical Trial. J Invest Dermatol. 2018 Sep;138(9):1973-1981. doi: 10.1016/j.jid.2018.03.1501. Epub 2018 Mar 17.
- Blauvelt A, Ferris LK, Yamauchi PS, Qureshi A, Leonardi CL, Farahi K, Fakharzadeh S, Hsu MC, Li S, Chevrier M, Smith K, Goyal K, Chen Y, Munoz-Elias EJ, Callis Duffin K. Extension of ustekinumab maintenance dosing interval in moderate-to-severe psoriasis: results of a phase IIIb, randomized, double-blinded, active-controlled, multicentre study (PSTELLAR). Br J Dermatol. 2017 Dec;177(6):1552-1561. doi: 10.1111/bjd.15722. Epub 2017 Nov 16.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
March 8, 2012
First Submitted That Met QC Criteria
March 8, 2012
First Posted (Estimate)
March 12, 2012
Study Record Updates
Last Update Posted (Estimate)
February 9, 2017
Last Update Submitted That Met QC Criteria
December 15, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR100708
- CNTO1275PSO3009 (Other Identifier: Janssen Biotech, Inc)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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