Study of Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis (AMVISION-1)

Bausch Health

Status and phase: Terminated; Phase 3

Conditions: Psoriatic Arthritis

Treatments: Drug: 140 mg brodalumab; Drug: Placebo; Drug: 210 mg brodalumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02029495

20090406

2013-003554-25 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis.

Full description

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 and week 24. The safety objective of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.

Enrollment: 478 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis criteria (CASPAR), with ≥ 3 tender and ≥ 3 swollen joints (excluding the distal interphalangeal joints)).
• Subjects must have at least 1 psoriatic skin lesion as well as either ≥ 1 erosion on a centrally read radiograph or an elevated CRP.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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478 participants in 3 patient groups, including a placebo group

210 mg brodalumab

Experimental group

Description:

Administered via subcutaneous injections

Treatment:

Drug: 210 mg brodalumab

140 mg brodalumab

Experimental group

Description:

Administered via subcutaneous injection

Treatment:

Drug: 140 mg brodalumab

Placebo

Placebo Comparator group

Description:

Administered via subcutaneous injection until week 24.

Treatment:

Drug: Placebo