Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis



Status:Completed
Conditions:Arthritis, Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:March 2014
End Date:October 2015

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A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis: AMVISION-2

The primary objective of this study is to evaluate the efficacy of brodalumab, compared to
placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate the
efficacy of brodalumab compared to placebo at week 16. The safety objective of this study is
to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.


Inclusion Criteria:

Subjects has a diagnosis of psoriatic arthritis (by the Classification of Psoriatic
Arthritis criteria (CASPAR), with ≥ 3 tender and ≥ 3 swollen joints (excluding distal
interphalangeal joints). Subjects must have at least

1 psoriatic skin lesion. Exclusion Criteria:

• -Subject has known history of active tuberculosis.

- Subject has a planned surgical intervention between baseline and the week 52
evaluation.

- Subject has an active infection or history of infections.

- Subject has any systemic disease (eg, renal failure, heart failure, hypertension,
liver disease, diabetes, anemia) considered by the Investigator to be clinically
significant and uncontrolled.

- Subject has any concurrent medical condition or electrocardiogram (ECG) abnormality
that, in the opinion of the investigator, could cause this study to be detrimental to
the subject.

Subject has severe depression measured by Personal Health Questionnaire Depression Scale
(PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide Severity Rating
Scale (e-CSSRS)

• Subject has a history or evidence of psychiatric disorder or substance abuse considered
by the Investigator to pose a risk to subject safety
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