Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)
Launched by ELI LILLY AND COMPANY · Jun 3, 2013
Trial Information
Current as of April 26, 2025
Withdrawn
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984)
- • Have active AS defined as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 and the spinal pain (back pain) score ≥4 on a numeric rating scale (NRS)
- • Participants should have been on nonsteroidal anti-inflammatory drugs (NSAIDs) with an inadequate response
- • Participants who are regularly taking NSAIDs or cyclooxygenase-2 (COX-2) inhibitors as part of their AS therapy are required to be on a stable dose
- • Participants who have been on a tumor necrosis factor alpha (TNF) inhibitor (not more than one) must have experienced an inadequate response
- • Total duration of prior therapy (NSAIDs and/or adequate physical therapy) should be at least 12 weeks
- • Men must agree to use a reliable method of birth control or remain abstinent during the study
- • Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
- Exclusion Criteria:
- • Participants with a total ankylosis of the spine
- • Prior or current treatment with adalimumab
- • Participants previously treated with any biological or other immunomodulating agents except for those targeting TNF
- • Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than ankylosing spondylitis
- • Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
- • Serious disorder or illness other than ankylosing spondylitis
- • Serious infection within the last 3 months
- • Breastfeeding or nursing (lactating) women
About Eli Lilly And Company
Eli Lilly and Company is a global healthcare leader dedicated to creating innovative medicines that improve patient outcomes across a range of therapeutic areas, including diabetes, oncology, immunology, and neurodegenerative diseases. With a rich history of scientific research and a commitment to advancing healthcare, Lilly invests significantly in clinical trials to develop new treatments and enhance existing therapies. The company prioritizes patient safety and ethical standards in its clinical research, fostering collaboration with healthcare professionals and stakeholders to ensure the delivery of high-quality, evidence-based solutions that address unmet medical needs worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Liège, , Belgium
Monterrey, , Mexico
Idaho Falls, Idaho, United States
Charlotte, North Carolina, United States
Dallas, Texas, United States
Bordeaux, , France
Nantes, , France
Trumbull, Connecticut, United States
Portland, Oregon, United States
Ann Arbor, Michigan, United States
Amsterdam, , Netherlands
Asheville, North Carolina, United States
Moscow, , Russian Federation
Paris, , France
Charleston, South Carolina, United States
Little Rock, Arkansas, United States
Atlanta, Georgia, United States
Seattle, Washington, United States
Gent, , Belgium
Genk, , Belgium
Madrid, , Spain
La Coruña, , Spain
Worcester, Massachusetts, United States
Santander, , Spain
Maastricht, , Netherlands
Montpellier, , France
Veszprem, , Hungary
Mexico City, , Mexico
Decatur, Georgia, United States
Sainte Foy, Quebec, Canada
Wolverhampton, West Midlands, United Kingdom
Bilbao, , Spain
Upland, California, United States
Amiens, , France
Marietta, Georgia, United States
Southampton, Hants, United Kingdom
Mineola, New York, United States
Toledo, Ohio, United States
Albany, New York, United States
North Charleston, South Carolina, United States
Breda, , Netherlands
Birmingham, Alabama, United States
Katowice, , Poland
Krakow, , Poland
Wroclaw, , Poland
Ivano Frankivsk, , Ukraine
Lutsk, , Ukraine
Tampa, Florida, United States
Winnipeg, Manitoba, Canada
Orleans, , France
Berlin, , Germany
Kennewick, Washington, United States
Guadalajara, , Mexico
Denver, Colorado, United States
Cumberland, Maryland, United States
Budapest, , Hungary
Cordoba, , Spain
Hagerstown, Maryland, United States
Lake Oswego, Oregon, United States
Wichita, Kansas, United States
Nyiregyhaza, , Hungary
Coventry, West Midlands, United Kingdom
Debrecen, , Hungary
Vinnytsya, , Ukraine
Columbia, South Carolina, United States
Hixon, Tennessee, United States
Jackson, Tennessee, United States
Kyiv, , Ukraine
Zaporizhzhia, , Ukraine
Brooklyn, New York, United States
Petrozavodsk, , Russian Federation
Ryazan, , Russian Federation
Saint Petersburg, , Russian Federation
Donetsk, , Ukraine
Odesa, , Ukraine
Bad Doberan, , Germany
Warsaw, , Poland
Barcelona, , Spain
Kazan, , Russian Federation
London, Greater London, United Kingdom
San Miguel De Tucuman, , Argentina
Sevilla, , Spain
Leiden, , Netherlands
Balatonfüred, , Hungary
Kalocsa, , Hungary
Nijmegen, , Netherlands
Rotterdam, , Netherlands
Sneek, , Netherlands
Poznan, , Poland
Barnaul, , Russian Federation
Ekaterinburg, , Russian Federation
Málaga, , Spain
Dnipropetrovsk, , Ukraine
Bradford, West Yorkshire, United Kingdom
Leeds, West Yorkshire, United Kingdom
Mons, , Belgium
Strasbourg, , France
Toronto, Ontario, Canada
Quebec City, Quebec, Canada
Boise, Idaho, United States
Cedar Rapids, Iowa, United States
Houston, Texas, United States
Buenos Aires, , Argentina
Caba, , Argentina
Córdoba, , Argentina
Edmonton, Alberta, Canada
Rimouski, Quebec, Canada
Brno, , Czech Republic
Bruntal, , Czech Republic
Kladno, , Czech Republic
Ostrava Trebovice, , Czech Republic
Prague, , Czech Republic
Zlin, , Czech Republic
Rennes, , France
Halle, , Germany
Heidelberg, , Germany
Ratingen, , Germany
Morelia, , Mexico
San Luis, , Mexico
Lublin, , Poland
Krasnoyarsk, , Russian Federation
Novosibirsk, , Russian Federation
Oviedo, , Spain
Kharkiv, , Ukraine
Vinnytsia, , Ukraine
Norwich, Norfolk, United Kingdom
Patients applied
Trial Officials
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Study Director
Eli Lilly and Company
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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