Overview

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