A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis
NCT ID: NCT02757352
Last Updated: 2020-03-13
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
303 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-08-02
Study Completion Date
2019-05-07
Brief Summary
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The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biologic disease modifying antirheumatic drug (bDMARD) naïve participants with nonradiographic axial spondyloarthritis (nonrad-axSpA).
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Detailed Description
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Conditions
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Axial 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
Participants received a starting dose of 80 or 160 milligram (mg) of ixekizumab given subcutaneously (SC) at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52 during the double-blind period.
Inadequate responders (IR) as determined by investigators could switch to ixekizumab 80 mg Q2W open label between week 16 and 44.
Group Type
EXPERIMENTAL
Ixekizumab
Intervention Type
DRUG
Administered SC
Q4W Ixekizumab
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52 during the double-blind period.
Inadequate responders as determined by investigators could switch to ixekizumab 80 mg Q2W open label week 16 and 44.
Group Type
EXPERIMENTAL
Ixekizumab
Intervention Type
DRUG
Administered SC
Placebo
Participants received placebo as 2 SC injections Q2W to week 52 during double-blind period.
Inadequate responders as determined by investigators could switch to ixekizumab 80 mg Q2W open label between week 16 and 44.
Group Type
PLACEBO_COMPARATOR
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.
* Diagnosis of nonradiographic axial spondyloarthritis (nr-axSpA) and fulfilling the 2009 Assessment of Spondyloarthritis International Society (ASAS) classification criteria.
* Have a history of back pain ≥3 months with age at onset \<45 years.
* Have active nr-axSpA defined as BASDAI ≥4 and total back pain ≥4 on a numeric rating scale (NRS) at screening and baseline.
* Have objective signs of inflammation by presence of sacroiliitis on MRI and/or presence of elevated C-reactive protein (CRP).
* In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS.
* If taking NSAIDS be on 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.
* Diagnosis of nonradiographic axial spondyloarthritis (nr-axSpA) and fulfilling the 2009 Assessment of Spondyloarthritis International Society (ASAS) classification criteria.
* Have a history of back pain ≥3 months with age at onset \<45 years.
* Have active nr-axSpA defined as BASDAI ≥4 and total back pain ≥4 on a numeric rating scale (NRS) at screening and baseline.
* Have objective signs of inflammation by presence of sacroiliitis on MRI and/or presence of elevated C-reactive protein (CRP).
* In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS.
* If taking NSAIDS be on 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 radiographic sacroiliitis fulfilling the 1984 modified New York criteria.
* Have received any prior, or are currently receiving treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents.
* Have 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 evidence of active anterior uveitis (an acute episode) within the last 42 days prior to baseline randomization.
* Have received any prior, or are currently receiving treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents.
* Have 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 evidence of active anterior uveitis (an acute episode) within the last 42 days prior to baseline randomization.
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
TriWest Research Assocaites
El Cajon, California, 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
Inlande Rheumatology Clinical Trials
Upland, California, United States
Site Status
Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC
Colorado Springs, Colorado, United States
Site Status
Clinical Research Center of CT/NY
Danbury, Connecticut, United States
Site Status
Sarasota Arthritis Center
Sarasota, Florida, United States
Site Status
West Broward Rheumatology Associates, Inc
Tamarac, Florida, United States
Site Status
Marietta Rheumatology
Marietta, Georgia, United States
Site Status
Institute of Arthritis Research
Idaho Falls, Idaho, United States
Site Status
The Arthritis & Diabetes Clinic Inc.
Monroe, Louisiana, United States
Site Status
Osteoporosis And Clinical Trial Center
Cumberland, Maryland, United States
Site Status
Osteoporosis And Clinical Trial Center
Hagerstown, Maryland, United States
Site Status
Glacier View Research Institute
Kalispell, Montana, United States
Site Status
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States
Site Status
Weill Cornell Physicians at Brooklyn Heights
Brooklyn, New York, United States
Site Status
Shanahan Rheumatology & Immunotherapy
Raleigh, North Carolina, United States
Site Status
Carolina Arthritis Associates
Wilmington, 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
Seattle Rheumatology Associates, P.L.L.C.
Seattle, Washington, United States
Site Status
Arthritis Northwest Rheumatology
Spokane, Washington, United States
Site Status
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Capital Federal, , Argentina
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Ciudad Autonoma de Buenos Aire, , Argentina
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Quilmes, , Argentina
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Rosario, , Argentina
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Rosario, , Argentina
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San Juan, , Argentina
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San Miguel de Tucumán, , Argentina
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San Miguel de Tucumán, , Argentina
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Vienna, , Austria
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Vienna, , Austria
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Goiás, , Brazil
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Juiz de Fora, , Brazil
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Rio de Janeiro, , Brazil
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Rio de Janeiro, , Brazil
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Québec, , Canada
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St. John's, , Canada
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Toronto, , Canada
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Trois-Rivières, , Canada
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Brno, , Czechia
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Ostrava, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Uherské Hradiště, , Czechia
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Helsinki, , Finland
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Helsinki, , Finland
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Hyvinkää, , Finland
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Kuopio, , Finland
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Oulu, , Finland
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Halle, Saxony-Anhalt, Germany
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Bad Doberan, , Germany
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Berlin, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Herne, , Germany
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Bunkyō City, , Japan
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Chūōku, , Japan
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Kita-gun, , Japan
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Kuwana, , Japan
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Nankoku, , Japan
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Nishinomiya, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Ōsaka, , Japan
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Sapporo, , Japan
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Sasebo, , Japan
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Suita-shi, , Japan
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Tenri, , Japan
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Yamagata, , Japan
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Chihuahua City, , Mexico
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Guadalajara, , 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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Elblag, , Poland
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Lodz, , Poland
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Nadarzyn, , Poland
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Poznan, , Poland
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Świdnik, , Poland
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Warsaw, , Poland
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Office: Perez-De Jesus, Amarilis
Caguas, PR, Puerto Rico
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Ponce School of Medicine CAIMED Center
Ponce, PR, Puerto Rico
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Mindful Medical Research
San Juan, PR, Puerto Rico
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Latin Clinical Trial Center
Santurce, , Puerto Rico
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Bucharest, , Romania
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Bucharest, , Romania
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Constanța, , Romania
Site Status
V.A. Nasonova Research Institute of Rheumatology
Moscow, , Russia
Site Status
City Clinical Hospital #1
Moscow, , Russia
Site Status
Ryazan State Medical University/Ryazan Clinical Regional Cardiological Dispensary
Ryazan, , Russia
Site Status
Clinical Rheumatology Hospital # 25
Saint Petersburg, , Russia
Site Status
Saratov Regional Clinical Hospital
Saratov, , Russia
Site Status
Clinical Hospital for Emergency Care
Yaroslavl, , Russia
Site Status
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
Daejeon, , South Korea
Site Status
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Seoul, , South Korea
Site Status
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
Seoul, , South Korea
Site Status
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
Seoul, , South Korea
Site Status
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.
Seoul, , South Korea
Site Status
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
Seoul, , South Korea
Site Status
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
Seoul, , South Korea
Site Status
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.
Seoul, , South Korea
Site Status
Countries
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United States
Argentina
Austria
Brazil
Canada
Czechia
Finland
Germany
Japan
Mexico
Netherlands
Poland
Puerto Rico
Romania
Russia
South Korea
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
Maksymowych WP, Baraliakos X, Lambert RG, Landewe R, Sandoval D, Carlier H, Lisse J, Li X, Hojnik M, Ostergaard M. Effects of ixekizumab treatment on structural changes in the sacroiliac joint: MRI assessments at 16 weeks in patients with non-radiographic axial spondyloarthritis. Lancet Rheumatol. 2022 Sep;4(9):e626-e634. doi: 10.1016/S2665-9913(22)00185-0. Epub 2022 Aug 9.
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
Deodhar A, Mease P, Marzo-Ortega H, Hunter T, Sandoval D, Kronbergs A, Lauzon S, Leung A, Navarro-Compan V. Ixekizumab improves sleep and work productivity in patients with non-radiographic axial spondyloarthritis: results from the COAST-X trial at 52 weeks. BMC Rheumatol. 2021 Sep 25;5(1):50. doi: 10.1186/s41927-021-00218-y.
Reference Type
DERIVED
Deodhar A, Mease P, Rahman P, Navarro-Compan V, Marzo-Ortega H, Hunter T, Sandoval D, Kronbergs A, Leon L, Shan M, Leung A, De Vlam K, Strand V. Ixekizumab Improves Patient-Reported Outcomes in Non-Radiographic Axial Spondyloarthritis: Results from the Coast-X Trial. Rheumatol Ther. 2021 Mar;8(1):135-150. doi: 10.1007/s40744-020-00254-z. Epub 2020 Dec 7.
Reference Type
DERIVED
Walsh JA, Magrey MN, Baraliakos X, Inui K, Weng MY, Lubrano E, van der Heijde D, Boonen A, Gensler LS, Strand V, Braun J, Hunter T, Li X, Zhu B, Leon L, Calderon DMS, Kiltz U. Improvement of Functioning and Health With Ixekizumab in the Treatment of Active Nonradiographic Axial Spondyloarthritis in a 52-Week, Randomized, Controlled Trial. Arthritis Care Res (Hoboken). 2022 Mar;74(3):451-460. doi: 10.1002/acr.24482. Epub 2022 Jan 26.
Reference Type
DERIVED
Deodhar A, van der Heijde D, Gensler LS, Kim TH, Maksymowych WP, Ostergaard M, Poddubnyy D, Marzo-Ortega H, Bessette L, Tomita T, Leung A, Hojnik M, Gallo G, Li X, Adams D, Carlier H, Sieper J; COAST-X Study Group. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial. Lancet. 2020 Jan 4;395(10217):53-64. doi: 10.1016/S0140-6736(19)32971-X. Epub 2019 Dec 5.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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http://www.lillytrialguide.com/en-US/studies/nonradiographic-axial%20spondyloarthritis/RHBX#?postal=
Click here for more information about this study: A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis (COAST-X)
Other Identifiers
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I1F-MC-RHBX
Identifier Type: OTHER
Identifier Source: secondary_id
2015-003938-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16180
Identifier Type: -
Identifier Source: org_study_id
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