A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis
NCT ID: NCT04285229
Last Updated: 2023-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
147 participants
INTERVENTIONAL
2020-04-10
2022-03-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ixekizumab
Participants received Ixekizumab during the double-blind and extended treatment periods (i.e.,) starting dose of 160 milligrams (mg) Ixekizumab in the beginning week followed by 80 mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection. No treatments were administered during the follow-up period.
Ixekizumab
Administered SC
Placebo
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection during the double-blind period. During the extension period, they received starting dose of 160 milligrams (mg) Ixekizumab in the beginning week followed by 80 mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection. No treatments were administered during follow-up period.
Ixekizumab
Administered SC
Placebo
Administered SC
Interventions
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Ixekizumab
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants have a history of back pain ≥3 months with age at onset \<45 years.
* Biologic naïve or have had prior treatment with 1 tumor necrosis factor (TNF) inhibitor.
* 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 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.
* 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Eli Lilly and Company
Locations
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Afflilated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
1st Hospital affiliated to Medical College of Shantou Univer
Shantou, Guangzhou, China
Wuhan Union Hospital
Wuhan, Hubei, China
Wu Han Tongji Hospital
Wuhan, Hubei, China
ZhuZhou Central Hospital
Zhuzhou, Hunan, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
HuaShan Hospital Affiliated To Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Peking University First Hospital
Beijing, , China
Beijing Hospital
Beijing, , China
Countries
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References
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Kong N, Hu J, Liu D, Li J, Wu H, Sun L, Lie D, Tan C, Li Z, Xiao Z, Huang C, Xu J, Yan Y, Li H, Zou H. Efficacy of Ixekizumab in Chinese Patients with Radiographic Axial Spondyloarthritis by Baseline C-Reactive Protein Level. Rheumatol Ther. 2025 Aug;12(4):627-639. doi: 10.1007/s40744-025-00765-7. Epub 2025 May 9.
Zhu X, Hu J, Liu D, Li J, Wu H, Sun L, Dai L, Tan C, Li Z, Xiao Z, Li X, Yan Y, Dou G, Sun Y, Zou H. Rapid and Sustained Effect of Ixekizumab on Patient Global, Spinal Pain, Stiffness, and Fatigue in Chinese Patients with Radiographic Axial Spondyloarthritis. Rheumatol Ther. 2024 Aug;11(4):1011-1022. doi: 10.1007/s40744-024-00688-9. Epub 2024 Jun 21.
Xue Y, Hu J, Liu D, Li J, Wu H, Tan C, Dai L, Sun L, Li Z, Xiao Z, Huang C, Yan Y, Ji F, Chen R, Zou H. Ixekizumab for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 52-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study. BioDrugs. 2024 Jan;38(1):145-156. doi: 10.1007/s40259-023-00625-2. Epub 2023 Sep 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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I1F-MC-RHCH
Identifier Type: OTHER
Identifier Source: secondary_id
16721
Identifier Type: -
Identifier Source: org_study_id
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