A Study of Ixekizumab (LY2439821) in bDMARD-Naive 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 safety and efficacy of the study drug known as ixekizumab in biological disease-modifying anti-rheumatic drugs (bDMARDs)-naive participants with radiographic axial spondyloarthritis (rad-axSpA).
Key facts
- Study ID
- NCT02696785
- Run by
- Eli Lilly and Company
- People needed
- 341
- Starts
- 2016-05-02
- Expected to finish
- 2018-10-17
- Last updated by the study team
- 2019-11-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Are ambulatory.
- 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.
- In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (for duration 4 weeks) or cannot tolerate NSAIDS.
- If taking NSAIDS be on a 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 total ankylosis of the spine.
- Have received any prior, or are currently receiving, treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents.
- 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
- Arizona Arthritis Research, PLC — Phoenix, Arizona, 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
- New England Research Associates — Trumbull, Connecticut, United States
- Sarasota Arthritis Center — Sarasota, Florida, United States
- Marietta Rheumatology — Marietta, Georgia, United States
- Center for Arthritis & Osteoporosis — Elizabethtown, Kentucky, United States
- Klein and Associates MD, PA — Cumberland, Maryland, United States
- Klein and Associates MD, PA — Hagerstown, Maryland, United States
- Arthritis Consultants — St Louis, Missouri, United States
- Glacier View Research Institute — Kalispell, Montana, United States
- Physician Research Collaboration, LLC — Lincoln, Nebraska, United States
- Shanahan Rheumatology & Immunotherapy — Raleigh, North Carolina, 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
- 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. — Brno, Czechia
- 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. — Berlin, Germany
- "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 — Hyōgo, Japan
- 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. — Warszawa, Netherlands
- 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. — Gwangjin-gu, South Korea
- 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. — Seoul, South Korea
Full record on ClinicalTrials.gov
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