A Study of Ixekizumab in Participants With Active Psoriatic Arthritis

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis.

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

Details

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

Criteria

Inclusion Criteria:

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

• Active psoriatic arthritis (PsA) defined as the presence of at least 3 tender and at least 3 swollen joints

• Presence of active psoriatic skin lesion or a personal 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

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 conventional DMARD

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

• Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab

• Serious disorder or illness other than psoriatic arthritis

• Serious infection within the last 3 months

• Breastfeeding or nursing (lactating) women