Clinical trial NCT04285229: A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spondyloarthritis
Keywords: Ankylosing spondylitis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-02-26
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response in Biological Disease-modifying Antirheumatic Drug (bDMARD)-naïve Participants
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving an ASAS40 Response
timeFrame: Week 16
measure: Percentage of Participants Achieving an ASAS20 Response
timeFrame: Week 16
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: Baseline, Week 16
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Response
timeFrame: Baseline, Week 16
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Baseline, Week 16
measure: Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score)
timeFrame: Baseline, Week 16
measure: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
timeFrame: Baseline, Week 16
measure: Change From Baseline in 36-Item SF-36 Mental Component Summary (MCS) Score
timeFrame: Baseline, Week 16
measure: Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)
timeFrame: Baseline, Week 16
measure: Change From Baseline in Mobility on the Bath Ankylosing Spondylitis Metrology Index (BASMI)
timeFrame: Baseline, Week 16
measure: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
timeFrame: Baseline, Week 16
measure: Change From Baseline in MRI Sacroiliac Joint(s) (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score
timeFrame: Baseline, Week 16
measure: Number of Participants With Anterior Uveitis
timeFrame: Baseline through Week 16
measure: Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score
timeFrame: Baseline, Week 52
measure: Percentage of Participants With Anti-Ixekizumab Antibodies
timeFrame: Week 16
measure: Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss)
timeFrame: Week 16
Other outcomes:
Locations:
city: Bengbu
country: China
facility: Afflilated Hospital of Bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Shantou
country: China
facility: 1st Hospital affiliated to Medical College of Shantou Univer
state: Guangzhou
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Wuhan
country: China
facility: Wu Han Tongji Hospital
state: Hubei
city: ZhuZhou
country: China
facility: ZhuZhou Central Hospital
state: Hunan
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical College
state: Inner Mongolia
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
state: Jiangxi
city: Shanghai
country: China
facility: HuaShan Hospital Affiliated To Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital Sichuan University
state: Sichuan
city: Urumqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Beijing Hospital
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: