A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriasis

In brief

The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash).

Key facts

Study ID

NCT02207244

Run by

Janssen Research & Development, LLC

People needed

992

Starts

2014-11-03

Expected to finish

2020-07-01

Last updated by the study team

2021-07-22

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) at least 6 months before the first administration of study agent
• 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) score >=3 at Screening and at Baseline
• Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline
• Must be a candidate for either systemic therapy or phototherapy for psoriasis

You may not qualify if…

• Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
• Participants who have ever received guselkumab or adalimumab
• 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 any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
• Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug

Where it is running

• Study site — Bakersfield, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Monica, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Coral Gables, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Newnan, Georgia, United States
• Study site — Sandy Springs, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Rolling Meadows, 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 — Andover, Massachusetts, United States
• Study site — Fort Gratiot, Michigan, United States
• Study site — Troy, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — New York, New York, United States
• Study site — Gahanna, Ohio, United States
• Study site — Norman, Oklahoma, United States
• Study site — Portland, Oregon, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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