A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis



Status:Completed
Conditions:Arthritis, Arthritis, Neurology, Orthopedic
Therapuetic Areas:Neurology, Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:11/30/2018
Start Date:May 2, 2016
End Date:October 17, 2018

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A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD-Naive Patients With Radiographic Axial Spondyloarthritis

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).


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
20
sites
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: John Reveille
Phone: 713-500-6900
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Colorado Springs, Colorado 80920
Principal Investigator: Michael Sayers
Phone: 719-475-9616
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Columbia, SC
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Cumberland, Maryland 21502
Principal Investigator: Steven Klein
Phone: 301-724-4337
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Denver, Colorado 80230
Principal Investigator: Ryan Antolini
Phone: 303-394-2828
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Elizabethtown, Kentucky 42701
Principal Investigator: Daksha Mehta
Phone: 270-769-2535
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Hagerstown, Maryland 21740
Principal Investigator: Mary Howell
Phone: 301-791-6680
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19582 Beach Boulevard
Huntington Beach, California 92648
Principal Investigator: Christine Thai
Phone: 949-385-0469
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Kalispell, Montana 59901
Principal Investigator: Roger Diegel
Phone: 406-755-1460
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Lincoln, Nebraska 68512
Principal Investigator: Melvin Churchill
Phone: 402-420-1212
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Marietta, Georgia 30060
Principal Investigator: Roel Querubin
Phone: 770-590-8328
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North Charleston, South Carolina 29406
Principal Investigator: Clarence Legerton
Phone: 843-572-1818
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Palm Desert, California 92260
Principal Investigator: Maria Greenwald
Phone: 760-341-6800
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Phoenix, Arizona 85032
Principal Investigator: Eric Peters
Phone: 480-626-6653
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Raleigh, North Carolina 27617
Principal Investigator: Joseph Shanahan
Phone: 919-405-2040
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Saint Louis, Missouri 63141
Principal Investigator: Akgun Ince
Phone: 314-567-5100
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Sarasota, Florida 34239
Principal Investigator: Jeffrey Kaine
Phone: 941-485-8314
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Spokane, Washington 99204
Principal Investigator: Eric Mueller
Phone: 509-838-6500
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Trumbull, Connecticut 06611
Principal Investigator: Geoffrey Gladstein
Phone: 203-374-9816
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