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: September 15, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Psoriasis
Drug: Ustekinumab 45 mg
Drug: Ustekinumab 90 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Janssen Biotech, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 479
Study Start Date: March 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550744

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States
United States, California
Bakersfield, California, United States
Irvine, California, United States
Los Angeles, California, United States
San Diego, California, United States
San Francisco, California, United States
Santa Monica, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Connecticut
Bridgeport, Connecticut, United States
United States, Florida
Miami, Florida, United States
St. Augustine, Florida, United States
Tampa, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
Plainfield, Indiana, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Troy, Michigan, United States
United States, Minnesota
Fridley, Minnesota, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, Nevada
Henderson, Nevada, United States
United States, New Hampshire
Lebanon, New Hampshire, United States
United States, New Jersey
East Windsor, New Jersey, United States
United States, New York
Bronx, New York, United States
New York, New York, United States
Williamsville, New York, United States
United States, Ohio
Columbus, Ohio, United States
United States, Oklahoma
Norman, Oklahoma, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
Yardley, Pennsylvania, United States
United States, Rhode Island
Johnston, Rhode Island, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Arlington, Texas, United States
Dallas, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Norfolk, Virginia, United States
United States, Washington
Spokane, Washington, United States
United States, West Virginia
Clarksburg, West Virginia, United States
Sponsors and Collaborators
Janssen Biotech, Inc.
Investigators
Study Director: Janssen Biotech, Inc. Clinical Trial Janssen Biotech, Inc.
  More Information

No publications provided

Responsible Party: Janssen Biotech, Inc.
ClinicalTrials.gov Identifier: NCT01550744     History of Changes
Other Study ID Numbers: CR100708, CNTO1275PSO3009
Study First Received: March 8, 2012
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on October 20, 2014