- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04285229
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Beijing, China, 100730
- Beijing Hospital
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Beijing, China, 100034
- Peking University First Hospital
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Anhui
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Bengbu, Anhui, China, 233004
- Afflilated Hospital of Bengbu Medical College
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Hefei, Anhui, China, 230001
- Anhui Provincial Hospital
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Guangdong
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Guangzhou, Guangdong, China, 510120
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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Shenzhen, Guangdong, China, 518020
- ShenZhen People's Hospital
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Guangzhou
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Shantou, Guangzhou, China, 515041
- 1st Hospital affiliated to Medical College of Shantou Univer
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Hubei
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Wuhan, Hubei, China, 430022
- Wuhan Union Hospital
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Wuhan, Hubei, China, 430030
- Wu Han Tongji Hospital
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Hunan
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ZhuZhou, Hunan, China, 412007
- ZhuZhou Central Hospital
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Inner Mongolia
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Baotou, Inner Mongolia, China, 014000
- The first affiliated hospital of Baotou medical college
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Jiangsu
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Nanjing, Jiangsu, China, 210029
- Jiangsu Province Hospital
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Nanjing, Jiangsu, China, 210000
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
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Jiangxi
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Pingxiang, Jiangxi, China, 337000
- Pingxiang People's Hospital
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Shanghai
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Shanghai, Shanghai, China, 20040
- Huashan Hospital Affiliated to Fudan University
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Sichuan
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Chengdu, Sichuan, China, 610041
- West China Hospital Sichuan University
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Xinjiang
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Urumqi, Xinjiang, China, 830001
- People's Hospital of Xinjiang Uygur Autonomous Region
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Yunnan
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Kunming, Yunnan, China, 650032
- First Affiliated Hospital of Kunming Medical University
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Zhejiang
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Hangzhou, Zhejiang, China, 310009
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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Administered SC
Other Names:
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Placebo Comparator: 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.
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Administered SC
Other Names:
Administered SC
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response in Biological Disease-modifying Antirheumatic Drug (bDMARD)-naïve Participants
Time Frame: Week 16
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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.
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Week 16
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving an ASAS40 Response
Time Frame: Week 16
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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.
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Week 16
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Percentage of Participants Achieving an ASAS20 Response
Time Frame: Week 16
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ASAS20 response is defined as a ≥20% improvement and an absolute improvement from baseline of ≥1 units (range 0 to 10) in ≥3 of 4 domains, and no worsening of ≥20% and ≥1 unit (range 0 to 10) in the remaining domain.
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Week 16
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Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time Frame: Baseline, Week 16
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ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are
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Baseline, Week 16
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Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Response
Time Frame: Baseline, Week 16
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The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis (rad-axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness.
Participants need to score each item with a score from 0 to 10 (NRS).
Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom.
LS mean was determined by MMRM with treatment, baseline CRP status, TNF inhibitors experience, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
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Baseline, Week 16
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Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: Baseline, Week 16
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The BASFI is a participant-reported assessment that establishes a participant's functional baseline and subsequent response to treatment.
The BASFI is composed with 10 questions to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants.
Participants respond to each question using an NRS scale (range 0 to 10).
The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10, with a higher score indicating worse function.
LS mean was determined by MMRM with treatment, baseline CRP status, TNF inhibitors experience, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
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Baseline, Week 16
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Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score)
Time Frame: Baseline, Week 16
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MRI score of spine was assessed using SPARCC method.
All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) were scored for bone marrow edema.
A single DVU has 18 scoring units, and each has score of 0 or 1, bringing the maximum total score to 414, the sum ranges from 0 to 414 with higher scores reflecting worse disease.
Scoring was performed by central readers.
LS mean was determined by ANCOVA with factors for treatment, baseline CRP status, TNF inhibitors experience, and baseline value.
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Baseline, Week 16
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Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
Time Frame: Baseline, Week 16
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SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality.
The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item.
The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores.
The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health.
LS mean was determined by MMRM with factors for treatment, baseline CRP status, TNF inhibitors experience, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
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Baseline, Week 16
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Change From Baseline in 36-Item SF-36 Mental Component Summary (MCS) Score
Time Frame: Baseline, Week 16
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SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality.
The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item.
The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores.
The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health.
LS mean was determined by MMRM with factors for treatment, baseline CRP status, TNF inhibitors experience, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
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Baseline, Week 16
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Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)
Time Frame: Baseline, Week 16
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High sensitivity CRP is the measure of acute phase reactant.
It was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on disease activity.
High sensitivity CRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation.
LS mean was determined by MMRM with treatment, baseline CRP status, TNF inhibitors experience, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
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Baseline, Week 16
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Change From Baseline in Mobility on the Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time Frame: Baseline, Week 16
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BASMI is a combined index comprising of 5 clinical measurements of spinal mobility in patients with radiographic axial spondyloarthritis (rad-axSpA).
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Baseline, Week 16
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Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Time Frame: Baseline, Week 16
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The MASES is an index used to measure the severity of enthesitis.
The MASES assesses 13 sites for enthesitis using a score of "0" for no activity or "1" for activity.
Sites assessed include costochondral 1 (right/left), costochondral 7 (right/left), spinal iliaca anterior superior (right/left), crista iliaca (right/left), spina iliaca posterior (right/left), processus spinosus L5, and Achilles tendon proximal insertion (right/left).
The MASES is the sum of all site scores (range 0 to 13); higher scores indicate more severe enthesitis.
LS mean was determined by MMRM with treatment, baseline CRP status, TNF inhibitors experience, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
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Baseline, Week 16
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Change From Baseline in MRI Sacroiliac Joint(s) (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score
Time Frame: Baseline, Week 16
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The SPARCC enthesitis is an index used to measure the severity of enthesitis.
The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity.
Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R).
The SPARCC is the sum of all site scores (range 0 to 16).
Higher scores indicate more severe enthesitis.
LS mean was determined by ANCOVA with factors for treatment, baseline CRP status, TNF inhibitors experience, and baseline value.
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Baseline, Week 16
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Number of Participants With Anterior Uveitis
Time Frame: Baseline through Week 16
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Anterior uveitis is an inflammation of the middle layer of the eye.
which includes the iris (colored part of the eye) and the adjacent tissue, known as the ciliary body.
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Baseline through Week 16
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Percentage of Participants With Anti-Ixekizumab Antibodies
Time Frame: Week 16
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A treatment emergent - antidrug antibody (TE-ADA) positive participant is defined as: a) a participant with a >= 4-fold increase over a positive baseline antibody titer; or b) for a negative baseline titer, a participant with an increase from the baseline to a level of >= 1:10.
Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.
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Week 16
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Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss)
Time Frame: Week 16
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Pharmacokinetics (PK): Steady-state trough serum concentration of Ixekizumab at week 16.
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Week 16
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Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score
Time Frame: Baseline, Week 52
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ASAS-NSAID score is used to present the NSAID intake by considering the type of NSAID, the total dose and the number of days taking NSAID during a period of interest (PI).
For the NSAID equivalence scoring system, "no NSAID intake" was set to a score value of 0, and the reference dose of NSAID (150 mg/day diclofenac) was set to a score value of 100.
The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac.
ASAS-NSAID score = (equivalent NSAID score) x (days of intake during PI) x (days per week)/(PI in days).
The total score range is from 0 to 100, higher the score greater the NSAID intake and 0 represents no intake at all.
A negative change from baseline indicates less NSAID consumption.
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Baseline, Week 52
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16721
- I1F-MC-RHCH (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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