A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT02203032

Run by

Janssen Research & Development, LLC

People needed

872

Starts

2014-10-07

Expected to finish

2016-05-24

Last updated by the study team

2017-09-12

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Bakersfield, California, United States
• Study site — Los Angeles, California, United States
• Study site — Santa Monica, California, United States
• Study site — Coral Gables, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Alpharetta, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Arlington Heights, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Skokie, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Plainfield, Indiana, United States
• Study site — Louisville, Kentucky, United States
• Study site — Boston, Massachusetts, United States
• Study site — Troy, Michigan, United States
• Study site — Buffalo, New York, United States
• Study site — New York, New York, United States
• Study site — Portland, Oregon, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Johnston, Rhode Island, United States
• Study site — Nashville, Tennessee, United States
• Study site — Arlington, Texas, United States
• Study site — Austin, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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