A Study of Ixekizumab in Participants With Active Psoriatic Arthritis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 412

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 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 392
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 3 months prior to randomization
•Breastfeeding or nursing (lactating) women

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on ACR20 at 24 Weeks;Secondary Objective: ·Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on modified Total Sharp Score (mTSS) through 24 weeks<br>·Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on ACR20 through 24 Weeks<br>·Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on Non-Arthritic Disease Assessments through 24 Weeks<br>·Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on Patient Reported Outcomes (PROs) through 24 Weeks;Primary end point(s): American College of Rheumatology 20 Index (ACR20);Timepoint(s) of evaluation of this end point: At 24 Weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ·modified Total Sharp Score (mTSS)<br>·ACR20<br>·Non-Arthritic Disease Assessments<br>·Patient Reported Outcomes (PRO)<br>;Timepoint(s) of evaluation of this end point: Baseline through 24 Weeks