Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Plaque Psoriasis

In brief

The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis. A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.

Key facts

Study ID: NCT01708629
Run by: Bausch Health Americas, Inc.
People needed: 1881
Starts: 2012-09-01
Expected to finish: 2015-10-01
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 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 — Mobile, Alabama, United States
Research Site — Phoenix, Arizona, United States
Research Site — Beverly Hills, California, United States
Research Site — Burbank, California, United States
Research Site — Encino, California, United States
Research Site — Fremont, California, United States
Research Site — Fullerton, California, United States
Research Site — Irvine, California, United States
Research Site — Los Angeles, California, United States
Research Site — Riverside, California, United States
Research Site — Sacramento, California, United States
Research Site — San Diego, California, United States
Research Site — San Diego, California, United States
Research Site — San Francisco, California, United States
Research Site — Denver, Colorado, United States
Research Site — Farmington, Connecticut, United States
Research Site — Trumbull, Connecticut, United States
Research Site — Boca Raton, Florida, United States
Research Site — Coral Gables, Florida, United States
Research Site — Hollywood, Florida, United States
Research Site — Jacksonville, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Ocala, Florida, United States
Research Site — Tamarac, Florida, United States
Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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