Psoriasis Clinical Trial
A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
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.
Full 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
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There is 1 Location for this study
Birmingham Alabama, , United States
Bakersfield California, , United States
Los Angeles California, , United States
Santa Monica California, , United States
Coral Gables Florida, , United States
Ocala Florida, , United States
Alpharetta Georgia, , United States
Atlanta Georgia, , United States
Arlington Heights Illinois, , United States
Chicago Illinois, , United States
Skokie Illinois, , United States
Indianapolis Indiana, , United States
Plainfield Indiana, , United States
Louisville Kentucky, , United States
Boston Massachusetts, , United States
Troy Michigan, , United States
Buffalo New York, , United States
New York New York, , United States
Portland Oregon, , United States
Pittsburgh Pennsylvania, , United States
Johnston Rhode Island, , United States
Nashville Tennessee, , United States
Arlington Texas, , United States
Austin Texas, , United States
Dallas Texas, , United States
San Antonio Texas, , United States
Webster Texas, , United States
Norfolk Virginia, , United States
Spokane Washington, , United States
Fremantle , , Australia
Victoria Park , , Australia
Woden , , Australia
Woolloongabba , , Australia
Surrey British Columbia, , Canada
Vancouver British Columbia, , Canada
Moncton New Brunswick, , Canada
Halifax Nova Scotia, , Canada
Ajax Ontario, , Canada
Richmond Hill Ontario, , Canada
Montreal Quebec, , Canada
Quebec , , Canada
Berlin , , Germany
Bonn , , Germany
Essen , , Germany
Gera , , Germany
Hamburg , , Germany
Leipzig , , Germany
Lübeck , , Germany
Mahlow , , Germany
Munster , , Germany
Witten , , Germany
Anyang , , Korea, Republic of
Incheon , , Korea, Republic of
Seoul , , Korea, Republic of
Bialystok , , Poland
Bydgoszcz , , Poland
Gdansk , , Poland
Krakow , , Poland
Lodz , , Poland
Lublin , , Poland
Olsztyn , , Poland
Poznan , , Poland
Poznań , , Poland
Torun , , Poland
Warszawa , , Poland
Wroclaw , , Poland
Åódź , , Poland
Chelyabinsk , , Russian Federation
Ekaterinburg , , Russian Federation
Krasnodar , , Russian Federation
Lipetsk , , Russian Federation
St-Petersburg , , Russian Federation
Stavropol , , Russian Federation
Ufa , , Russian Federation
Alcorcon , , Spain
Alicante , , Spain
Barcelona , , Spain
La Coruña , , Spain
Madrid , , Spain
Taichung , , Taiwan
Tainan , , Taiwan
Taipei , , Taiwan
Taoyuan , , Taiwan
Dudley , , United Kingdom
Dundee , , United Kingdom
London , , United Kingdom
Salford , , United Kingdom
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