A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis
NCT ID: NCT02696798
Last Updated: 2020-06-17
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
316 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-04-12
Study Completion Date
2019-05-03
Brief Summary
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The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in tumor necrosis factor (TNF) inhibitor-experienced participants with radiographic axial spondyloarthritis (rad-axSpA).
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Detailed Description
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Conditions
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Spondyloarthritis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Q2W Ixekizumab
Double Blind Period: Starting dose of 80 or 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 14.
Extended Treatment Period: 80 mg ixekizumab given SC Q2W from week 16 to week 52.
Group Type
EXPERIMENTAL
Ixekizumab
Intervention Type
DRUG
Administered SC
Q4W Ixekizumab
Double Blind Period: Starting dose of 80 or 160 mg ixekizumab given SC at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 14.
Extended Treatment Period: 80 mg ixekizumab given SC Q4W from week 16 to week 52.
Group Type
EXPERIMENTAL
Ixekizumab
Intervention Type
DRUG
Administered SC
Placebo
Double Blind Period: Placebo given SC Q2W to week 14.
Extended Treatment Period: Starting dose of 160 mg ixekizumab given SC at week 16 followed by 80 mg ixekizumab given SC Q2W or Q4W from week 16 to week 52.
Group Type
PLACEBO_COMPARATOR
Ixekizumab
Intervention Type
DRUG
Administered SC
Placebo
Intervention Type
DRUG
Administered SC
Interventions
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Ixekizumab
Administered SC
Intervention Type
DRUG
Placebo
Administered SC
Intervention Type
DRUG
Other Intervention Names
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LY2439821
Eligibility Criteria
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Inclusion Criteria
* Are ambulatory.
* Have an established 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.
* Have had prior treatment with at least 1 and not more than 2 TNF inhibitors.
* Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs.
* Have a history of prior therapy for axSpa for at least 12 weeks prior to screening.
* Have an established 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.
* Have had prior treatment with at least 1 and not more than 2 TNF inhibitors.
* Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs.
* 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 never taken a TNF inhibitor medication or have taken more than 2.
* 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.
* Have never taken a TNF inhibitor medication or have taken more than 2.
* 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.
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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Arizona Arthritis Research, PLC
Phoenix, Arizona, United States
Site Status
Rheumatology Center of San Diego
Escondido, California, United States
Site Status
Care Access Research - Huntington Beach
Huntington Beach, California, United States
Site Status
Desert Medical Advances
Palm Desert, California, United States
Site Status
Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC
Colorado Springs, Colorado, United States
Site Status
Denver Arthritis Center
Denver, Colorado, United States
Site Status
Clinical Research Center of CT/NY
Danbury, Connecticut, United States
Site Status
Arthritis Rheumatic Disease Specialties
Aventura, Florida, United States
Site Status
Sarasota Arthritis Center
Sarasota, Florida, United States
Site Status
Marietta Rheumatology
Marietta, Georgia, United States
Site Status
St Luke's Clinic - Intermountain Orthopaedics
Boise, Idaho, United States
Site Status
Institute of Arthritis Research
Idaho Falls, Idaho, United States
Site Status
Center for Arthritis & Osteoporosis
Elizabethtown, Kentucky, United States
Site Status
Klein and Associates MD, PA
Cumberland, Maryland, United States
Site Status
Osteoporosis And Clinical Trial Center
Hagerstown, Maryland, United States
Site Status
Arthritis Consultants
St Louis, Missouri, United States
Site Status
The Center for Rheumatology
Albany, New York, United States
Site Status
Shanahan Rheumatology & Immunotherapy
Raleigh, North Carolina, United States
Site Status
Oregon Health and Science University
Portland, Oregon, United States
Site Status
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Site Status
Articularis Healthcare Group, INC dba Columbia Arthritis Ctr
Columbia, South Carolina, United States
Site Status
Low Country Research Center
North Charleston, South Carolina, United States
Site Status
Univ of Texas Health Science Center - Houston
Houston, Texas, United States
Site Status
Southwest Rheumatology, P.A.
Mesquite, Texas, United States
Site Status
Center for Arthritis and Rheumatic Diseases, PC
Chesapeake, Virginia, United States
Site Status
Arthritis Northwest Rheumatology
Spokane, Washington, United States
Site Status
Rheumatology and Immunotherapy Center
Franklin, Wisconsin, United States
Site Status
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Rosario, , Argentina
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Rosario, , Argentina
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San Miguel de Tucumán, , Argentina
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San Miguel de Tucumán, , Argentina
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Curitiba, , Brazil
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Goiás, , Brazil
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Juiz de Fora, , Brazil
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Porto Alegre, , Brazil
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São Paulo, , Brazil
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St. John's, , Canada
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Trois-Rivières, , Canada
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Victoria, , Canada
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Helsinki, , Finland
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Hyvinkää, , Finland
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Oulu, , Finland
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Clermont, , France
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Le Kremlin-Bicêtre, , France
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Montpellier, , France
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Orléans, , France
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Paris, , France
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Tours, , France
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Berlin, , Germany
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Ashkelon, , Israel
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Haifa, , Israel
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Petah Tikva, , Israel
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Tel Aviv, , Israel
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Milan, , Italy
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Reggio Emilia, , Italy
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Roma, , Italy
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Siena, , Italy
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Hyōgo, , Japan
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Yamagata, , Japan
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Chihuahua City, , Mexico
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Guadalajara, , Mexico
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Mexicali, , Mexico
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Mérida, , Mexico
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Monterrey, , Mexico
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San Luis Potosí City, , Mexico
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Amsterdam, , Netherlands
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Sneek, , Netherlands
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Bydgoszcz, , Poland
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Elblag, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Świdnik, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Office: Perez-De Jesus, Amarilis
Caguas, PR, Puerto Rico
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GCM Medical Group PSC
San Juan, PR, Puerto Rico
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Mindful Medical Research
San Juan, PR, Puerto Rico
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Santurce, , Puerto Rico
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Daejeon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Córdoba, , Spain
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Elche, , Spain
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Madrid, , Spain
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Sabadell, , Spain
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Seville, , Spain
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Basingstoke, , United Kingdom
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Norwich, , United Kingdom
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Solihull, , United Kingdom
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Stoke-on-Trent, , United Kingdom
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Wolverhampton, , United Kingdom
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Wythenshawe, , United Kingdom
Site Status
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United States
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France
Germany
Israel
Italy
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Poland
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United Kingdom
References
Explore related publications, articles, or registry entries linked to this study.
Navarro-Compan V, Reveille JD, Rahman P, Maldonado-Cocco JA, Magrey M, Bolce R, Panni T, Kronbergs A, Rudwaleit M. Ixekizumab Improves Signs, Symptoms, and Quality of Life in Patients with Axial Spondyloarthritis Irrespective of Symptom Duration. Adv Ther. 2025 Sep;42(9):4706-4716. doi: 10.1007/s12325-025-03305-5. Epub 2025 Jul 22.
Reference Type
DERIVED
Deodhar A, Poddubnyy D, Rahman P, Ermann J, Tomita T, Bolce R, Leage SL, Kronbergs A, Johnson C, Araujo J, Leung A, van der Heijde D. Long-Term Safety and Efficacy of Ixekizumab in Patients With Axial Spondyloarthritis: 3-year Data From the COAST Program. J Rheumatol. 2023 Aug;50(8):1020-1028. doi: 10.3899/jrheum.221022. Epub 2023 Feb 15.
Reference Type
DERIVED
Ortolan A, Ramiro S, Ramonda R, van der Heijde D. External validation of the alternative Ankylosing Spondylitis Disease Activity Score in three randomized clinical trials of ixekizumab. Rheumatology (Oxford). 2023 Jun 1;62(6):2257-2261. doi: 10.1093/rheumatology/keac618.
Reference Type
DERIVED
van der Horst-Bruinsma IE, de Vlam K, Walsh JA, Bolce R, Hunter T, Sandoval D, Zhu D, Geneus V, Soriano ER, Magrey M. Baseline Characteristics and Treatment Response to Ixekizumab Categorised by Sex in Radiographic and Non-radiographic Axial Spondylarthritis Through 52 Weeks: Data from Three Phase III Randomised Controlled Trials. Adv Ther. 2022 Jun;39(6):2806-2819. doi: 10.1007/s12325-022-02132-2. Epub 2022 Apr 16.
Reference Type
DERIVED
Maksymowych WP, Bolce R, Gallo G, Seem E, Geneus VJ, Sandoval DM, Ostergaard M, Tada K, Baraliakos X, Deodhar A, Gensler LS. Ixekizumab in radiographic axial spondyloarthritis with and without elevated C-reactive protein or positive magnetic resonance imaging. Rheumatology (Oxford). 2022 Nov 2;61(11):4324-4334. doi: 10.1093/rheumatology/keac104.
Reference Type
DERIVED
van der Heijde D, Ostergaard M, Reveille JD, Baraliakos X, Kronbergs A, Sandoval DM, Li X, Carlier H, Adams DH, Maksymowych WP. Spinal Radiographic Progression and Predictors of Progression in Patients With Radiographic Axial Spondyloarthritis Receiving Ixekizumab Over 2 Years. J Rheumatol. 2022 Mar;49(3):265-273. doi: 10.3899/jrheum.210471. Epub 2021 Dec 1.
Reference Type
DERIVED
Deodhar AA, Mease PJ, Rahman P, Navarro-Compan V, Strand V, Hunter T, Bolce R, Leon L, Lauzon S, Marzo-Ortega H. Ixekizumab improves spinal pain, function, fatigue, stiffness, and sleep in radiographic axial Spondyloarthritis: COAST-V/W 52-week results. BMC Rheumatol. 2021 Sep 20;5(1):35. doi: 10.1186/s41927-021-00205-3.
Reference Type
DERIVED
Dougados M, Wei JC, Landewe R, Sieper J, Baraliakos X, Van den Bosch F, Maksymowych WP, Ermann J, Walsh JA, Tomita T, Deodhar A, van der Heijde D, Li X, Zhao F, Bertram CC, Gallo G, Carlier H, Gensler LS; COAST-V and COAST-W Study Groups. Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W). Ann Rheum Dis. 2020 Feb;79(2):176-185. doi: 10.1136/annrheumdis-2019-216118. Epub 2019 Nov 4.
Reference Type
DERIVED
Mease P, Walsh JA, Baraliakos X, Inman R, de Vlam K, Wei JC, Hunter T, Gallo G, Sandoval D, Zhao F, Dong Y, Bolce R, Marzo-Ortega H. Translating Improvements with Ixekizumab in Clinical Trial Outcomes into Clinical Practice: ASAS40, Pain, Fatigue, and Sleep in Ankylosing Spondylitis. Rheumatol Ther. 2019 Sep;6(3):435-450. doi: 10.1007/s40744-019-0165-3. Epub 2019 Jun 28.
Reference Type
DERIVED
Deodhar A, Poddubnyy D, Pacheco-Tena C, Salvarani C, Lespessailles E, Rahman P, Jarvinen P, Sanchez-Burson J, Gaffney K, Lee EB, Krishnan E, Santisteban S, Li X, Zhao F, Carlier H, Reveille JD; COAST-W Study Group. Efficacy and Safety of Ixekizumab in the Treatment of Radiographic Axial Spondyloarthritis: Sixteen-Week Results From a Phase III Randomized, Double-Blind, Placebo-Controlled Trial in Patients With Prior Inadequate Response to or Intolerance of Tumor Necrosis Factor Inhibitors. Arthritis Rheumatol. 2019 Apr;71(4):599-611. doi: 10.1002/art.40753. Epub 2019 Mar 8.
Reference Type
DERIVED
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
http://www.lillytrialguide.com/EN-us/studies/arthritis/rhbw
Click here for more information about this study: A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis (COAST-W)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
I1F-MC-RHBW
Identifier Type: OTHER
Identifier Source: secondary_id
2015-003937-84
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16179
Identifier Type: -
Identifier Source: org_study_id
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