A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Axial Spondyloarthritis

In brief

The purpose of this study is to evaluate, in participants having achieved a state of sustained remission, if the ixekizumab treatment groups are superior to the placebo group in maintaining response during the randomized withdrawal-retreatment period in participants with axial spondyloarthritis.

Key facts

Study ID

NCT03129100

Run by

Eli Lilly and Company

People needed

773

Starts

2017-05-09

Expected to finish

2021-05-27

Last updated by the study team

2022-06-13

Who can join

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

You may qualify if…

• Have completed the final study visit in Study RHBV (NCT02696785), RHBW (NCT02696798), or RHBX (NCT02757352).
• (Note: Participants from Study RHBX are not eligible if they permanently discontinued ixekizumab and were receiving a tumor necrosis factor [TNF] inhibitor).
• Must agree to use a reliable method of birth control.

You may not qualify if…

• Have significant uncontrolled disorders or abnormal laboratory values that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered.
• Have a known hypersensitivity to ixekizumab or any component of this investigational product.
• Had investigational product permanently discontinued during a previous ixekizumab study.
• Had temporary investigational product interruption at any time during or at the final study visit of a previous ixekizumab study and, in the opinion of the investigator, restarting ixekizumab poses an unacceptable risk for the participant's participation in the study.
• Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol.
• Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

Where it is running

• 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
• 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
• 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
• Klein and Associates MD, PA — Hagerstown, Maryland, United States
• Arthritis Consultants Inc. — St Louis, Missouri, United States
• Glacier View Research Institute — Kalispell, Montana, United States
• Physician Research Collaboration, LLC — Lincoln, Nebraska, United States
• Shanahan Rheumatology & Immunotherapy, PLLC — 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
• Articularis Healthcare d/b/a/ Low Country Rheumatology, PA — Summerville, South Carolina, United States
• Univ of Texas Health Science Center - Houston — Houston, Texas, United States
• Arthritis Northwest PLLC — Spokane, Washington, United States
• Clinica Adventista de Belgrano — Ciudad de Buenos Aires, Buenos Aires, Argentina
• CER Instituto Medico — Quilmes, Buenos Aires, Argentina
• Arizona Arthritis & Rheumatology Research — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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