A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis
A Multicenter, Randomized, Double-Blind and Placebo-Controlled 16-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Chinese Patients With Radiographic Axial Spondyloarthritis
2 other identifiers
interventional
147
1 country
19
Brief Summary
The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in Chinese participants with radiographic axial spondyloarthritis (r-axSpA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2020
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2020
CompletedFirst Posted
Study publicly available on registry
February 26, 2020
CompletedStudy Start
First participant enrolled
April 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2022
CompletedResults Posted
Study results publicly available
June 28, 2022
CompletedApril 14, 2023
April 1, 2023
12 months
February 19, 2020
May 19, 2022
April 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response in Biological Disease-modifying Antirheumatic Drug (bDMARD)-naïve Participants
ASAS40 is defined as improvement from baseline of greater than or equal to (\>=) 40 % and absolute improvement from baseline of at least 2 units (range of 0 to 10) in at least 3 of the following 4 domains without any worsening in the remaining domain. 1. Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active). 2. Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3. Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. 4. Inflammation based on Q5 \& Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity \& duration of stiffness): Score ranges from "0" (none) and "10" (very severe).
Week 16
Secondary Outcomes (16)
Percentage of Participants Achieving an ASAS40 Response
Week 16
Percentage of Participants Achieving an ASAS20 Response
Week 16
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
Baseline, Week 16
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Response
Baseline, Week 16
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
Baseline, Week 16
- +11 more secondary outcomes
Study Arms (2)
Ixekizumab
EXPERIMENTALParticipants 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.
Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- Have an established diagnosis of radiographic axial spondyloarthritis (r-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.
- 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.
You may not qualify if:
- Have total ankylosis of the spine.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Afflilated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004, China
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020, China
1st Hospital affiliated to Medical College of Shantou Univer
Shantou, Guangzhou, 515041, China
Wuhan Union Hospital
Wuhan, Hubei, 430022, China
Wu Han Tongji Hospital
Wuhan, Hubei, 430030, China
ZhuZhou Central Hospital
Zhuzhou, Hunan, 412007, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, 014000, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337000, China
HuaShan Hospital Affiliated To Fudan University
Shanghai, Shanghai Municipality, 20040, China
West China Hospital Sichuan University
Chengdu, Sichuan, 610041, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830001, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Peking University First Hospital
Beijing, 100034, China
Beijing Hospital
Beijing, 100730, China
Related Publications (4)
Zhu X, Hu J, Liu D, Li J, Wu H, Sun L, Dai L, Tan C, Li Z, Xiao Z, Wang Y, Dong L, Yan Y, Li H, Zou H. Efficacy of Ixekizumab in Chinese Patients with Radiographic-Axial Spondyloarthritis by Baseline Inflammation Status on Magnetic Resonance Imaging. Rheumatol Ther. 2026 Jan 6. doi: 10.1007/s40744-025-00819-w. Online ahead of print.
PMID: 41495585DERIVEDKong 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.
PMID: 40343690DERIVEDZhu 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.
PMID: 38907104DERIVEDXue 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.
PMID: 37737952DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2020
First Posted
February 26, 2020
Study Start
April 10, 2020
Primary Completion
March 31, 2021
Study Completion
March 17, 2022
Last Updated
April 14, 2023
Results First Posted
June 28, 2022
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.