Clinical trial NCT01550744: A Study of Ustekinumab to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Psoriasis
Ustekinumab
STELARA
Skin disease
Monoclonal
Lead sponsor: Janssen Biotech, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-12
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1)
timeFrame: Up to 24 weeks (Week 88 up to Week 112 [total 7 visits])
Secondary outcomes:
measure: The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
timeFrame: Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112
measure: The Number of Visits for Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 75 Response
timeFrame: Up to 24 weeks (Week 88 up to Week 112 [total 7 visits])
measure: The Percentage of Participants With a PASI 75 Response Over Time
timeFrame: Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Bakersfield
country: United States
state: California
city: Irvine
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Bridgeport
country: United States
state: Connecticut
city: Coral Gables
country: United States
state: Florida
city: St. Augustine
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Plainfield
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Troy
country: United States
state: Michigan
city: Fridley
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Henderson
country: United States
state: Nevada
city: Lebanon
country: United States
state: New Hampshire
city: East Windsor
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Gahanna
country: United States
state: Ohio
city: Norman
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Pittsburgh
country: United States
state: Pennsylvania
city: Yardley
country: United States
state: Pennsylvania
city: Johnston
country: United States
state: Rhode Island
city: Nashville
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Clarksburg
country: United States
state: West Virginia
Study officials:
affiliation: Janssen Biotech, Inc.
name: Janssen Biotech, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.