A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

• Status: Completed
• Trial end date: 2018-10-30
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the safety and long-term efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Antirheumatic Agents; Ixekizumab

Criteria

Inclusion Criteria:

• Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria

• Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints

• Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)

• Men must agree to use a reliable method of birth control or remain abstinent during the study

• Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

• Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)

Exclusion Criteria:

• Current or prior use of biologic agents for treatment of Ps or PsA

• Inadequate response to greater than or equal to 4 conventional disease-modifying antirheumatic drugs (DMARDS)

• Current use of more than one cDMARDs

• Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA

• Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy

• Serious disorder or illness other than psoriatic arthritis

• Serious infection within the last 3 months

• Breastfeeding or nursing (lactating) women