AMG 827 in Subjects With Psoriatic Arthritis

• Status: Terminated
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic arthritis

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen; Bausch Health Americas, Inc.
• Treatments: Antibodies, Monoclonal; Brodalumab

Criteria

Inclusion Criteria:

• Subject has had a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis (CASPAR) criteria) for at least 6 months

• Subject has ≥ 3 tender and ≥ 3 swollen joints

Exclusion Criteria:

• Subject has an active infection or history of infections (systemic anti-infectives were used within 28 days; requiring hospitalization or intravenous anti-infectives within 8 weeks; recurrent or chronic)

• Significant concurrent medical conditions

• Pregnant or breast feeding

• Significant Laboratory abnormalities

• Use of sulfasalazine, hydroxychloroquine, systemically administered calcineurin inhibitors, azathioprine, parenteral corticosteroids including intramuscular or intraarticular administration, or live vaccines within 28 days

• Use of anti-TNF therapy within 2 months

• Use of an anti-interleukin (IL)12/IL-23 drug or other experimental or commercially available biologic therapies for psoriasis and/or psoriatic arthritis within 3 months

• Prior use of rituximab

• Prior use of anti-IL-17 biologic therapy, including AMG 827