Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)
NCT ID: NCT01870284
Last Updated: 2014-09-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
PHASE3
Study Classification
INTERVENTIONAL
Study Start Date
2014-07-31
Study Completion Date
2018-04-30
Brief Summary
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This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active AS.
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Detailed Description
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Conditions
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Spondylitis, Ankylosing
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Ixekizumab Dosing Regimen 1
Administered by 80 milligram (mg) subcutaneous (SC) injection
Group Type
EXPERIMENTAL
Ixekizumab
Intervention Type
DRUG
Administered SC
Ixekizumab Dosing Regimen 2
Administered by 80 mg SC Injection
Group Type
EXPERIMENTAL
Ixekizumab
Intervention Type
DRUG
Administered SC
Placebo
Placebo for ixekizumab and placebo for adalimumab administered by SC injection
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Administered SC
Adalimumab
Administered by 40 mg SC injection
Group Type
ACTIVE_COMPARATOR
Adalimumab
Intervention Type
DRUG
Administered SC
Interventions
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Ixekizumab
Administered SC
Intervention Type
DRUG
Placebo
Administered SC
Intervention Type
DRUG
Adalimumab
Administered SC
Intervention Type
DRUG
Other Intervention Names
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LY2439821
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Birmingham, Alabama, United States
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Little Rock, Arkansas, United States
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Upland, California, United States
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Denver, Colorado, United States
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Trumbull, Connecticut, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Marietta, Georgia, United States
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Boise, Idaho, United States
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Idaho Falls, Idaho, United States
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Cedar Rapids, Iowa, United States
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Wichita, Kansas, United States
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Cumberland, Maryland, United States
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Mineola, New York, United States
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Toledo, Ohio, United States
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Lake Oswego, Oregon, United States
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Portland, Oregon, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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North Charleston, South Carolina, United States
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Hixon, Tennessee, United States
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Houston, Texas, United States
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Kennewick, Washington, United States
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Seattle, Washington, United States
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Buenos Aires, , Argentina
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Caba, , Argentina
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Córdoba, , Argentina
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San Miguel de Tucumán, , Argentina
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Genk, , Belgium
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Ghent, , Belgium
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Liège, , Belgium
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Mons, , Belgium
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Edmonton, Alberta, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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Rimouski, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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Brno, , Czechia
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Bruntál, , Czechia
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Kladno, , Czechia
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Ostrava - Trebovice, , Czechia
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Prague, , Czechia
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Zlín, , Czechia
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Amiens, , France
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Bordeaux, , France
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Montpellier, , France
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Nantes, , France
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Orléans, , France
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Paris, , France
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Rennes, , France
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Strasbourg, , France
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Bad Doberan, , Germany
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Berlin, , Germany
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Halle, , Germany
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Heidelberg, , Germany
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Ratingen, , Germany
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Balatonfüred, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Kalocsa, , Hungary
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Nyíregyháza, , Hungary
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Veszprém, , Hungary
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Guadalajara, , Mexico
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Mexico City, , Mexico
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Monterrey, , Mexico
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Morelia, , Mexico
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San Luis, , Mexico
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Amsterdam, , Netherlands
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Breda, , Netherlands
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Leiden, , Netherlands
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Maastricht, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Sneek, , Netherlands
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Katowice, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Barnaul, , Russia
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Kazan', , Russia
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Krasnoyarsk, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Petrozavodsk, , Russia
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Ryazan, , Russia
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Saint Petersburg, , Russia
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Yekaterinburg, , Russia
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A Coruña, , Spain
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Barcelona, , Spain
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Bilbao, , Spain
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Córdoba, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Oviedo, , Spain
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Santander, , Spain
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Seville, , Spain
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Dnipropetrovsk, , Ukraine
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Donetsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Lutsk, , Ukraine
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Odesa, , Ukraine
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Vinnytsia, , Ukraine
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Zaporizhzhia, , Ukraine
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London, Greater London, United Kingdom
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Southampton, Hants, United Kingdom
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Norwich, Norfolk, United Kingdom
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Coventry, West Midlands, United Kingdom
Site Status
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Wolverhampton, West Midlands, United Kingdom
Site Status
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Bradford, West Yorkshire, United Kingdom
Site Status
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Leeds, West Yorkshire, United Kingdom
Site Status
Countries
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United States
Argentina
Belgium
Canada
Czechia
France
Germany
Hungary
Mexico
Netherlands
Poland
Russia
Spain
Ukraine
United Kingdom
Other Identifiers
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I1F-MC-RHAO
Identifier Type: OTHER
Identifier Source: secondary_id
13650
Identifier Type: -
Identifier Source: org_study_id
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