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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02024646
• Date of registration: 27/12/2013
• Prospective Registration: Yes
• Primary sponsor: Bausch Health Americas, Inc.
• Public title: Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis AMVISION-2
• Scientific title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis: AMVISION-2
• Date of first enrolment: March 2014
• Target sample size: 484
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02024646
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Canada, France, Germany, Greece, Hungary, Latvia, Mexico, Poland, Russian Federation, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Psoriatic Arthritis

Intervention(s)

Drug: 210 mg brodalumab

Drug: 140 mg brodalumab

Drug: Placebo

Primary Outcome(s)

ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16 [Time Frame: Baseline and 16 Weeks]

Secondary ID(s)

2013-003553-16

20110144

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 20/08/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02024646