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

Phase 3

Completed

• Conditions: Psoriatic Arthritis
• Interventions: Drug: 210 mg brodalumab; Drug: 140 mg brodalumab; Drug: Placebo

• Registration Number: NCT02024646
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-27
• Study First Submitted QC: 2013-12-27
• Study First Posted: 2013-12-31
• Study Start: 2014-03
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Disposition First Submitted: 2016-03-14
• Disposition First Submitted QC: 2016-03-14
• Disposition First Posted: 2016-04-13
• Results First Submitted: 2016-11-02
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-08
• Last Update Submitted: 2020-08-08
• Results First Posted: 2020-08-20
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 484

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
210 mg brodalumab	210 mg brodalumab	Administered via subcutaneous injections.
140 mg brodalumab	140 mg brodalumab	Administered via subcutaneous injection.
Placebo	Placebo	Administered via subcutaneous injection until week 24.

Primary Outcome Measures

Name	Time	Method
ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16	Baseline and 16 Weeks	ACR20 is used as a measurement of the proportion of subjects who are reaching a 20% improvement of tender an swollen joint counts. The higher percent of subjects reaching a higher improvement percentage shows greater success.

Trial Locations

Locations (1)

Research Site; 🇷🇺 Voronezh, Russian Federation