A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriasis

In brief

The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of participants with moderate to severe plaque-type psoriasis.

Key facts

Study ID

NCT03090100

Run by

Janssen Research & Development, LLC

People needed

1048

Starts

2017-04-27

Expected to finish

2018-09-20

Last updated by the study team

2019-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of plaque-type psoriasis (with or without [Psoriatic Arthritis]PsA) for at least 6 months before the first administration of study drug
• A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 and agree to urine pregnancy testing before receiving injections
• Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug
• Agree not to receive a Bacille Calmette-Guérin (BCG) vaccination during the study, or within 12 months after the last administration of study drug
• Agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during study

You may not qualify if…

• Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
• Has previously received guselkumab or secukinumab
• Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
• Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
• Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins

Where it is running

• Southern California Permanente Medical Group — Los Angeles, California, United States
• Dermatology Specialists — Oceanside, California, United States
• MedDerm Associates — San Diego, California, United States
• San Luis Dermatology & Laser Clinic, Inc — San Luis Obispo, California, United States
• Southern California Dermatology — Santa Ana, California, United States
• Clinical Research Center of Connecticut — Danbury, Connecticut, United States
• Olympian Clinical Research — Clearwater, Florida, United States
• Florida Academic Dermatology Centers — Coral Gables, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Park Avenue Dermatology — Orange Park, Florida, United States
• Atlanta Dermatology, Vein & Research Center — Alpharetta, Georgia, United States
• Advanced Medical Research — Atlanta, Georgia, United States
• Marietta Dermatology Clinical Research — Marietta, Georgia, United States
• Arlington Dermatology — Rolling Meadows, Illinois, United States
• Northshore Universite Healthsystem — Skokie, Illinois, United States
• Dawes Fretzin Clinical Research Group — Indianapolis, Indiana, United States
• Indiana Clinical Trial Center — Plainfield, Indiana, United States
• Dermatology Specialists — Louisville, Kentucky, United States
• DermAssociates, PC — Rockville, Maryland, United States
• Great Lakes Research Group — Bay City, Michigan, United States
• Henry Ford Medical Center — Detroit, Michigan, United States
• Hamzavi Dermatology — Fort Gratiot, Michigan, United States
• Somerset Skin Centre — Troy, Michigan, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• University of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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