Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Psoriasis

In brief

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

Key facts

Study ID

NCT01708590

Run by

Bausch Health Americas, Inc.

People needed

661

Starts

2012-08-01

Expected to finish

2015-08-01

Last updated by the study team

2020-01-03

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 must be considered, in the opinion of the investigator, to be a suitable candidate for treatment with a biologic per regional labeling
• 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 stopped using certain psoriasis therapies as defined in the study protocol
• Subject has previously used any anti-IL-17 biologic therapy

Where it is running

• Research Site — Bakersfield, California, United States
• Research Site — Encino, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Francisco, California, United States
• Research Site — San Ramon, California, United States
• Research Site — Santa Monica, California, United States
• Research Site — Alpharetta, Georgia, United States
• Research Site — West Dundee, Illinois, United States
• Research Site — Richmond, Kentucky, United States
• Research Site — Columbia, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Fort Gratiot, Michigan, United States
• Research Site — St Louis, Missouri, United States
• Research Site — St Louis, Missouri, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Omaha, Nebraska, United States
• Research Site — Buffalo, New York, United States
• Research Site — Forest Hills, New York, United States
• Research Site — Rochester, New York, United States
• Research Site — Stony Brook, New York, United States
• Research Site — Wilmington, North Carolina, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Portland, Oregon, United States
• Research Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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