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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 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 6, 2013
Last verified: June 2013
History of Changes
  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:

Drug Information available for: Ustekinumab
U.S. FDA Resources

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: 478
Study Start Date: March 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01550744

  Show 41 Study Locations
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: June 6, 2013
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, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013