A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Axial Spondyloarthritis

In brief

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biologic disease modifying antirheumatic drug (bDMARD) naïve participants with nonradiographic axial spondyloarthritis (nonrad-axSpA).

Key facts

Study ID

NCT02757352

Run by

Eli Lilly and Company

People needed

303

Starts

2016-08-02

Expected to finish

2019-05-07

Last updated by the study team

2020-03-13

Who can join

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

You may qualify if…

• Are ambulatory.
• Diagnosis of nonradiographic axial spondyloarthritis (nr-axSpA) and fulfilling the 2009 Assessment of Spondyloarthritis International Society (ASAS) classification criteria.
• Have a history of back pain ≥3 months with age at onset <45 years.
• Have active nr-axSpA defined as BASDAI ≥4 and total back pain ≥4 on a numeric rating scale (NRS) at screening and baseline.
• Have objective signs of inflammation by presence of sacroiliitis on MRI and/or presence of elevated C-reactive protein (CRP).
• In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS.
• If taking NSAIDS be on stable dose for at least 2 weeks prior to randomization.
• Have a history of prior therapy for axSpA for at least 12 weeks prior to screening.

You may not qualify if…

• Have radiographic sacroiliitis fulfilling the 1984 modified New York criteria.
• Have received any prior, or are currently receiving treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents.
• Have 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.
• Have evidence of active anterior uveitis (an acute episode) within the last 42 days prior to baseline randomization.

Where it is running

• TriWest Research Assocaites — El Cajon, California, United States
• 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
• Inlande Rheumatology Clinical Trials — Upland, California, United States
• Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC — Colorado Springs, Colorado, United States
• Clinical Research Center of CT/NY — Danbury, Connecticut, United States
• Sarasota Arthritis Center — Sarasota, Florida, United States
• West Broward Rheumatology Associates, Inc — Tamarac, Florida, United States
• Marietta Rheumatology — Marietta, Georgia, United States
• Institute of Arthritis Research — Idaho Falls, Idaho, United States
• The Arthritis & Diabetes Clinic Inc. — Monroe, Louisiana, United States
• Osteoporosis And Clinical Trial Center — Cumberland, Maryland, United States
• Osteoporosis And Clinical Trial Center — Hagerstown, Maryland, United States
• Glacier View Research Institute — Kalispell, Montana, United States
• Physician Research Collaboration, LLC — Lincoln, Nebraska, United States
• Weill Cornell Physicians at Brooklyn Heights — Brooklyn, New York, United States
• Shanahan Rheumatology & Immunotherapy — Raleigh, North Carolina, United States
• Carolina Arthritis Associates — Wilmington, 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
• Seattle Rheumatology Associates, P.L.L.C. — Seattle, Washington, United States
• Arthritis Northwest Rheumatology — Spokane, Washington, United States
• Arizona Arthritis Research, PLC — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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