Recruitment

Recruitment Status
Completed
Estimated Enrollment
800

Inclusion Criterias

Have an Investigator's Global Assessment (IGA) >=3 at Screening and at Baseline
Be a candidate for phototherapy or systemic treatment for psoriasis (either naïve or history of previous treatment)
Have an involved body surface area (BSA) >= 10 percent (%) at Screening and at Baseline
...
Have an Investigator's Global Assessment (IGA) >=3 at Screening and at Baseline
Be a candidate for phototherapy or systemic treatment for psoriasis (either naïve or history of previous treatment)
Have an involved body surface area (BSA) >= 10 percent (%) at Screening and at Baseline
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

Exclusion Criterias

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 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
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
...
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 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
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 previously received guselkumab or ustekinumab

Summary

Conditions
Psoriasis
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 99 years
Gender
Both males and females

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 ina...

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.

Inclusion Criterias

Have an Investigator's Global Assessment (IGA) >=3 at Screening and at Baseline
Be a candidate for phototherapy or systemic treatment for psoriasis (either naïve or history of previous treatment)
Have an involved body surface area (BSA) >= 10 percent (%) at Screening and at Baseline
...
Have an Investigator's Global Assessment (IGA) >=3 at Screening and at Baseline
Be a candidate for phototherapy or systemic treatment for psoriasis (either naïve or history of previous treatment)
Have an involved body surface area (BSA) >= 10 percent (%) at Screening and at Baseline
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

Exclusion Criterias

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 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
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
...
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 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
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 previously received guselkumab or ustekinumab

Locations

Bonn
Poznań
Lipetsk
Essen
Bakersfield, California
...
Bonn
Poznań
Lipetsk
Essen
Bakersfield, California
Skokie, Illinois
Plainfield, Indiana
Anyang
Witten
Pittsburgh, Pennsylvania
Barcelona
Moncton, New Brunswick
Alcorcon
Quebec
Lodz
Dudley
Indianapolis, Indiana
Alpharetta, Georgia
New York, New York
Tainan
Halifax, Nova Scotia
Surrey, British Columbia
Troy, Michigan
Victoria Park
Boston, Massachusetts
Dallas, Texas
Gera
Incheon
Olsztyn
Ekaterinburg
Seoul
San Antonio, Texas
Atlanta, Georgia
Fremantle
Łódź
Arlington Heights, Illinois
Lübeck
Vancouver, British Columbia
Los Angeles, California
Ajax, Ontario
Wroclaw
Austin, Texas
Salford
Norfolk, Virginia
Hamburg
Woolloongabba
Bialystok
Madrid
Montreal, Quebec
Mahlow
Alicante
Leipzig
Louisville, Kentucky
Berlin
Chicago, Illinois
Woden
Stavropol
Arlington, Texas
Krasnodar
London
Coral Gables, Florida
Johnston, Rhode Island
Santa Monica, California
Warszawa
St-Petersburg
Portland, Oregon
Gdansk
Bydgoszcz
Taichung
Krakow
Munster
Torun
Taipei
Lublin
La Coruña
Nashville, Tennessee
Chelyabinsk
Poznan
Birmingham, Alabama
Dundee
Richmond Hill, Ontario
Webster, Texas
Taoyuan
Spokane, Washington
Ufa
Buffalo, New York
Ocala, Florida

Tracking Information

NCT #
NCT02203032
Collaborators
Not Provided
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC