A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriatic Arthritis

In brief

The main purpose of this study is to evaluate how effective and safe the study drug known as ixekizumab is in participants with active psoriatic arthritis.

Key facts

Study ID

NCT02349295

Run by

Eli Lilly and Company

People needed

363

Starts

2014-12-31

Expected to finish

2019-06-26

Last updated by the study team

2020-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• Have had prior treatment with at least 1 and not more than 2 tumor necrosis factor (TNF) inhibitors. The participant must have discontinued at least 1 TNF inhibitor due to either an inadequate response (based on a minimum of 12 weeks on therapy) or documented intolerance.

You may not qualify if…

• Current use of biologic agents for treatment of Ps or PsA
• Inadequate response to greater than 2 biologic 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

Where it is running

• Arizona Arthritis & Rheumatology Research — Glendale, Arizona, United States
• Arizona Arthritis & Rheumatology Research, PLLC — Mesa, Arizona, United States
• Arizona Arthritis & Rheumatology Research — Phoenix, Arizona, United States
• Little Rock Diagnostic Clinic — Little Rock, Arkansas, United States
• University of California - San Diego — La Jolla, California, United States
• Purushotham & Akther Kotha MD Inc — La Mesa, California, United States
• Stanford University Hospital — Palo Alto, California, United States
• East Bay Rheumatology Medical Group — San Leandro, California, United States
• Office: Dr Robin K Dore — Tustin, California, United States
• Rheumatology Associates of South Florida — Boca Raton, Florida, United States
• Jeffrey Alper MD Research — Naples, Florida, United States
• Arthritis & Osteoporosis Treatment Center, PA — Orange Park, Florida, United States
• Florida Medical Clinic PA — Zephyrhills, Florida, United States
• Diagnostic Rheumatology and Research — Indianapolis, Indiana, United States
• Physicians Clinic of Iowa — Cedar Rapids, Iowa, United States
• Heartland Research Associates — Wichita, Kansas, United States
• Bluegrass Community Research. Inc — Lexington, Kentucky, United States
• Johns Hopkins Arthritis Center — Baltimore, Maryland, United States
• Klein and Associates MD, PA — Cumberland, Maryland, United States
• Klein and Associates MD, PA — Hagerstown, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Beals Institute PC — Lansing, Michigan, United States
• North MS Medical Clinics, Inc. — Tupelo, Mississippi, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Rheumatology Associates PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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