P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Moderate to Severe Plaque Psoriasis

In brief

The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses

Key facts

Study ID

NCT01708603

Run by

Bausch Health Americas, Inc.

People needed

1831

Starts

2012-08-01

Expected to finish

2015-10-01

Last updated by the study team

2020-01-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has had stable moderate to severe plaque psoriasis for at least 6 months
• Subject has involved body surface area (BSA) ≥ 10%, PASI ≥ 12, and sPGA ≥ 3 at screening and at baseline

You may not qualify if…

• Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at (eg, eczema) that would interfere with study evaluations
• Subject has known history of Crohn's disease
• Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
• Subject has not stopped using certain psoriasis therapies as defined in the study protocol
• Subject has previously used ustekinumab or any anti-IL-17 biologic therapy
• Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study
• Female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile

Where it is running

• Research Site — Tampa, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Newnan, Georgia, United States
• Research Site — Snellville, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Skokie, Illinois, United States
• Research Site — Carmel, Indiana, United States
• Research Site — Plainfield, Indiana, United States
• Research Site — South Bend, Indiana, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Lake Charles, Louisiana, United States
• Research Site — Lake Charles, Louisiana, United States
• Research Site — New Orleans, Louisiana, United States
• Research Site — Rockville, Maryland, United States
• Research Site — Silver Spring, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — North Andover, Massachusetts, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Fridley, Minnesota, United States
• Research Site — Omaha, Nebraska, United States
• Research Site — Henderson, Nevada, United States
• Research Site — Brooklyn, New York, United States
• Research Site — Pembroke Pines, Florida, United States

Full record on ClinicalTrials.gov

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