Status:
COMPLETED
A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis
Lead Sponsor:
Eli Lilly and Company
Conditions:
Spondyloarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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).
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2022
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT04285229
Start Date
April 10 2020
End Date
March 17 2022
Last Update
April 14 2023
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
Afflilated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233004
2
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
3
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
4
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020