A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Spondyloarthritis

In brief

The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in tumor necrosis factor (TNF) inhibitor-experienced participants with radiographic axial spondyloarthritis (rad-axSpA).

Key facts

Study ID

NCT02696798

Run by

Eli Lilly and Company

People needed

316

Starts

2016-04-12

Expected to finish

2019-05-03

Last updated by the study team

2020-06-17

Who can join

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

You may qualify if…

• Are ambulatory.
• Have an established diagnosis of radiographic axial spondyloarthritis (rad-xSpA) with sacroiliitis defined radiographically according to the modified New York criteria.
• Participants have a history of back pain ≥3 months with age at onset <45 years.
• Have had prior treatment with at least 1 and not more than 2 TNF inhibitors.
• Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs.
• Have a history of prior therapy for axSpa for at least 12 weeks prior to screening.

You may not qualify if…

• Have total ankylosis of the spine.
• Have never taken a TNF inhibitor medication or have taken more than 2.
• Have recently received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year.
• Have an ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis.
• Have a compromised immune system.
• Have any other serious and/or uncontrolled diseases.
• Have either a current diagnosis or a recent history of malignant disease.
• Have had major surgery within 8 weeks of baseline, or will require surgery during the study.
• Are pregnant or breastfeeding.

Where it is running

• Rheumatology Center of San Diego — Escondido, California, United States
• Care Access Research - Huntington Beach — Huntington Beach, California, United States
• Desert Medical Advances — Palm Desert, California, United States
• Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC — Colorado Springs, Colorado, United States
• Denver Arthritis Center — Denver, Colorado, United States
• Clinical Research Center of CT/NY — Danbury, Connecticut, United States
• Arthritis Rheumatic Disease Specialties — Aventura, Florida, United States
• Sarasota Arthritis Center — Sarasota, Florida, United States
• Marietta Rheumatology — Marietta, Georgia, United States
• St Luke's Clinic - Intermountain Orthopaedics — Boise, Idaho, United States
• Institute of Arthritis Research — Idaho Falls, Idaho, United States
• Center for Arthritis & Osteoporosis — Elizabethtown, Kentucky, United States
• Klein and Associates MD, PA — Cumberland, Maryland, United States
• Osteoporosis And Clinical Trial Center — Hagerstown, Maryland, United States
• Arthritis Consultants — St Louis, Missouri, United States
• The Center for Rheumatology — Albany, New York, United States
• Shanahan Rheumatology & Immunotherapy — Raleigh, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Articularis Healthcare Group, INC dba Columbia Arthritis Ctr — Columbia, South Carolina, United States
• Low Country Research Center — North Charleston, South Carolina, United States
• Univ of Texas Health Science Center - Houston — Houston, Texas, United States
• Southwest Rheumatology, P.A. — Mesquite, Texas, United States
• Center for Arthritis and Rheumatic Diseases, PC — Chesapeake, Virginia, United States
• Arizona Arthritis Research, PLC — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.