A Long-Term Efficacy and Safety 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 the safety and long-term efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis.
Key facts
- Study ID
- NCT02584855
- Run by
- Eli Lilly and Company
- People needed
- 394
- Starts
- 2015-09-14
- Expected to finish
- 2018-10-30
- Last updated by the study team
- 2019-11-15
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)
You may not qualify if…
- 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
Where it is running
- Arizona Arthritis & Rheumatology Research, PLLC — Mesa, Arizona, United States
- Arizona Arthritis Research, PLC — Phoenix, Arizona, United States
- University of California, Davis - Health Systems — Sacramento, California, United States
- East Bay Rheumatology Medical Group — San Leandro, California, United States
- Arthritis & Osteoporosis Treatment Center, PA — Orange Park, Florida, United States
- Florida Medical Clinic PA — Zephyrhills, Florida, United States
- Physicians Clinic of Iowa — Cedar Rapids, Iowa, United States
- Heartland Research Associates — Wichita, Kansas, United States
- Klein and Associates MD, PA — Cumberland, Maryland, United States
- Klein and Associates MD, PA — Hagerstown, Maryland, United States
- University of Massachusetts Medical Center — Worcester, Massachusetts, United States
- Glacier View Research Institute — Kalispell, Montana, United States
- Arthritis, Rheumatic & Back Disease Associates — Voorhees Township, New Jersey, United States
- Weill Cornell Physicians at Brooklyn Heights — Brooklyn, New York, United States
- Robert A. Harrell, III, MD — Durham, North Carolina, United States
- Pennsylvania Regional Center for Arthritis & Osteoarthritis — Wyomissing, Pennsylvania, United States
- Pioneer Research Solutions — Cypress, Texas, United States
- Arthritis Care & Diagnostic Center P.A. — Dallas, Texas, United States
- Kadlec Clinic Rheumatology — Kennewick, Washington, United States
- Seattle Rheumatology Associates, P.L.L.C. — Seattle, Washington, United States
- Arthritis Northwest Rheumatology — Spokane, Washington, United States
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Plovdiv, Bulgaria
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Plovdiv, Bulgaria
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Rousse, Bulgaria
- Arizona Arthritis & Rheumatology Research — Glendale, Arizona, United States
Full record on ClinicalTrials.gov
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