Clinical trial NCT02203032: A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
Official title: A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Psoriasis
Plaque-type psoriasis
Guselkumab
Ustekinumab
CNTO 1959
Monoclonal antibody
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2014-07-29
Enrollment: 872
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash) who had inadequate response to ustekinumab.

Detailed description: This is a randomized (assignment of study drug by chance), double-blind (participants nor study staff will know the identity of study drugs), multicenter study to evaluate efficacy and safety of guselkumab for the treatment of participants with moderate to severe plaque-type psoriasis who had an inadequate response to ustekinumab. The study will consist of a screening period, open-label and double-blind treatment periods, and a follow-up period. The treatment period will have 2 phases: an open-label treatment phase during which all participants will receive ustekinumab at Weeks 0 and 4 and a blinded treatment phase during which participants with an inadequate Investigator's Global Assessment response (IGA≥2) to ustekinumab at Week 16 will be randomized to receive either guselkumab or ustekinumab through Week 44. Participants with an IGA response of 0 or 1 (cleared or minimal disease) at Week 16 will continue to receive open-label treatment with ustekinumab every 12 weeks through Week 40. All participants will complete a follow-up phase through Week 52 for efficacy and through Week 60 for safety evaluations. The total duration of the study will be approximately 64 weeks (includes a 4-week screening period). Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis for at least 6 months before the first administration of study drug
* Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (\>=) 12 at Screening and at Baseline
* Have an Investigator's Global Assessment (IGA) \>=3 at Screening and at Baseline
* Have an involved body surface area (BSA) \>= 10 percent (%) at Screening and at Baseline
* Be a candidate for phototherapy or systemic treatment for psoriasis (either naïve or history of previous treatment)

Exclusion Criteria:

* Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Has unstable cardiovascular disease, defined as a recent clinical deterioration (example \[eg\], unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
* Currently has a malignancy or has a history of malignancy within 5 years before Screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration, or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study drug administration)
* Has previously received guselkumab or ustekinumab

Primary outcomes:
measure: Number of Visits at Which Participants Achieved an Investigator's Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40
timeFrame: Week 28 through Week 40
Secondary outcomes:
measure: Number of Visits at Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 90 Response From Week 28 Through Week 40
timeFrame: Week 28 through Week 40
measure: Number of Visits at Which Participants Achieved an IGA Score of Cleared (0) From Week 28 Through Week 40
timeFrame: Week 28 through Week 40
measure: Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) at Week 28
timeFrame: Week 28
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Bakersfield
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Coral Gables
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Alpharetta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Arlington Heights
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Skokie
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: Boston
country: United States
state: Massachusetts
city: Troy
country: United States
state: Michigan
city: Buffalo
country: United States
state: New York
city: New York
country: United States
state: New York
city: Portland
country: United States
state: Oregon
city: Pittsburgh
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: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Webster
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Fremantle
country: Australia
city: Victoria Park
country: Australia
city: Woden
country: Australia
city: Woolloongabba
country: Australia
city: Surrey
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Moncton
country: Canada
state: New Brunswick
city: Halifax
country: Canada
state: Nova Scotia
city: Ajax
country: Canada
state: Ontario
city: Richmond Hill
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Essen
country: Germany
city: Gera
country: Germany
city: Hamburg
country: Germany
city: Leipzig
country: Germany
city: Lübeck
country: Germany
city: Mahlow
country: Germany
city: Munster
country: Germany
city: Witten
country: Germany
city: Anyang
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Gdansk
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Olsztyn
country: Poland
city: Poznan
country: Poland
city: Poznań
country: Poland
city: Torun
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Łódź
country: Poland
city: Chelyabinsk
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Lipetsk
country: Russian Federation
city: St-Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Ufa
country: Russian Federation
city: Alcorcon
country: Spain
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: La Coruña
country: Spain
city: Madrid
country: Spain
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Dudley
country: United Kingdom
city: Dundee
country: United Kingdom
city: London
country: United Kingdom
city: Salford
country: United Kingdom
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: