Clinical trial NCT01870284: Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)
Official title: 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 Patients With Active Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Spondylitis, Ankylosing
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-06-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active AS.


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

Primary outcomes:
measure: Efficacy of Ixekizumab in Participants with Ankylosing Spondylitis (AS). Measure: Assessment of SpondyloArthritis International Society Criteria (ASAS20)
timeFrame: 16 Weeks
Secondary outcomes:
measure: Efficacy of Ixekizumab in Participants with AS. Measure: ASAS
timeFrame: 16 Weeks
measure: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)
timeFrame: Baseline through 16 Weeks
measure: Efficacy of Ixekizumab in Participants with AS. Measure: Non-Arthritic Disease Assessments
timeFrame: Baseline through 16 Weeks
measure: Efficacy of Ixekizumab in Participants with AS. Measure: Peripheral Joint Counts
timeFrame: 16 Weeks
measure: Efficacy of Ixekizumab in Participants with AS. Measure: Spinal Mobility
timeFrame: Baseline through 16 Weeks
measure: Efficacy of Ixekizumab in Participants with AS. Measure: modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS)
timeFrame: Baseline through 108 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 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.
state: Alabama
city: Little Rock
country: United States
facility: 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.
state: Arkansas
city: Upland
country: United States
facility: 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.
state: California
city: Denver
country: United States
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state: Colorado
city: Trumbull
country: United States
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state: Connecticut
city: Tampa
country: United States
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state: Florida
city: Atlanta
country: United States
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state: Georgia
city: Decatur
country: United States
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state: Georgia
city: Marietta
country: United States
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state: Georgia
city: Boise
country: United States
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state: Idaho
city: Idaho Falls
country: United States
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state: Idaho
city: Cedar Rapids
country: United States
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state: Iowa
city: Wichita
country: United States
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state: Kansas
city: Cumberland
country: United States
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state: Maryland
city: Hagerstown
country: United States
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state: Maryland
city: Worcester
country: United States
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state: Massachusetts
city: Ann Arbor
country: United States
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state: Michigan
city: Albany
country: United States
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state: New York
city: Brooklyn
country: United States
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state: New York
city: Mineola
country: United States
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state: New York
city: Asheville
country: United States
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state: North Carolina
city: Charlotte
country: United States
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state: North Carolina
city: Toledo
country: United States
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state: Ohio
city: Lake Oswego
country: United States
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state: Oregon
city: Portland
country: United States
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state: Oregon
city: Charleston
country: United States
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state: South Carolina
city: Columbia
country: United States
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state: South Carolina
city: North Charleston
country: United States
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state: South Carolina
city: Hixon
country: United States
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state: Tennessee
city: Jackson
country: United States
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state: Tennessee
city: Dallas
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Kennewick
country: United States
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state: Washington
city: Seattle
country: United States
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state: Washington
city: Buenos Aires
country: Argentina
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city: Caba
country: Argentina
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city: Córdoba
country: Argentina
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city: San Miguel De Tucuman
country: Argentina
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city: Genk
country: Belgium
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city: Gent
country: Belgium
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city: Liège
country: Belgium
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city: Mons
country: Belgium
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city: Edmonton
country: Canada
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state: Alberta
city: Winnipeg
country: Canada
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state: Manitoba
city: Toronto
country: Canada
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state: Ontario
city: Quebec City
country: Canada
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state: Quebec
city: Rimouski
country: Canada
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state: Quebec
city: Sainte-Foy
country: Canada
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state: Quebec
city: Brno
country: Czech Republic
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city: Bruntal
country: Czech Republic
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city: Kladno
country: Czech Republic
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city: Ostrava - Trebovice
country: Czech Republic
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city: Prague
country: Czech Republic
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city: Zlin
country: Czech Republic
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city: Amiens
country: France
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city: Bordeaux
country: France
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city: Montpellier
country: France
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city: Nantes
country: France
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city: Orleans
country: France
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city: Paris
country: France
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city: Rennes
country: France
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city: Strasbourg
country: France
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city: Bad Doberan
country: Germany
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city: Berlin
country: Germany
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city: Halle
country: Germany
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city: Heidelberg
country: Germany
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city: Ratingen
country: Germany
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city: Balatonfüred
country: Hungary
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city: Budapest
country: Hungary
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city: Debrecen
country: Hungary
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city: Kalocsa
country: Hungary
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city: Nyiregyhaza
country: Hungary
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city: Veszprem
country: Hungary
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city: Guadalajara
country: Mexico
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city: Mexico City
country: Mexico
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city: Monterrey
country: Mexico
facility: 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.
city: Morelia
country: Mexico
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city: San Luis
country: Mexico
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city: Amsterdam
country: Netherlands
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city: Breda
country: Netherlands
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city: Leiden
country: Netherlands
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city: Maastricht
country: Netherlands
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city: Nijmegen
country: Netherlands
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city: Rotterdam
country: Netherlands
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city: Sneek
country: Netherlands
facility: 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.
city: Katowice
country: Poland
facility: 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.
city: Krakow
country: Poland
facility: 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.
city: Lublin
country: Poland
facility: 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.
city: Poznan
country: Poland
facility: 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.
city: Warsaw
country: Poland
facility: 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.
city: Wroclaw
country: Poland
facility: 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.
city: Barnaul
country: Russian Federation
facility: 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.
city: Ekaterinburg
country: Russian Federation
facility: 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.
city: Kazan
country: Russian Federation
facility: 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.
city: Krasnoyarsk
country: Russian Federation
facility: 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.
city: Moscow
country: Russian Federation
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city: Novosibirsk
country: Russian Federation
facility: 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.
city: Petrozavodsk
country: Russian Federation
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city: Ryazan
country: Russian Federation
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city: Saint Petersburg
country: Russian Federation
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city: Barcelona
country: Spain
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city: Bilbao
country: Spain
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city: Cordoba
country: Spain
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city: La Coruña
country: Spain
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city: Madrid
country: Spain
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city: Málaga
country: Spain
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city: Oviedo
country: Spain
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city: Santander
country: Spain
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city: Sevilla
country: Spain
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city: Dnipropetrovsk
country: Ukraine
facility: 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.
city: Donetsk
country: Ukraine
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city: Ivano-Frankivsk
country: Ukraine
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city: Kharkiv
country: Ukraine
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city: Kyiv
country: Ukraine
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city: Lutsk
country: Ukraine
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city: Odesa
country: Ukraine
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city: Vinnytsia
country: Ukraine
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city: Vinnytsya
country: Ukraine
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city: Zaporizhzhia
country: Ukraine
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city: London
country: United Kingdom
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state: Greater London
city: Southampton
country: United Kingdom
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state: Hants
city: Norwich
country: United Kingdom
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state: Norfolk
city: Coventry
country: United Kingdom
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state: West Midlands
city: Wolverhampton
country: United Kingdom
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state: West Midlands
city: Bradford
country: United Kingdom
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state: West Yorkshire
city: Leeds
country: United Kingdom
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state: West Yorkshire
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: