This is a phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of AK111 in subjects with active ankylosing spondylitis.
The purpose of this study is to evaluate the efficacy and safety of AK111 in the treatment of subjects with active ankylosing spondylitis. Subjects will be randomized to receive AK111 or placebo following subcutaneous injection. The study period for each subject will be 25 weeks, including a screening period of up to 35 days, followed by a treatment period of 12 weeks and a follow up period of 8 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
125
The first affiliated hospital of Bengbu medical college
Bengbu, Anhui, China
Peking university people's hospital
Beijing, Beijing Municipality, China
Percentage of subjects who achieve Assessment of SpondyloArthritis International Society 20% improvement (ASAS20) response at Week 16.
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global, pain, function (assessed by BASFI) and inflammation (mean of Ankylosing Spondylitis Disease Activity Index \[BASDAI\] question 5 and 6 ). ASAS20 response is defined as improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 \[least\] to 10 \[worst\]) and no worsening of ≥20% and ≥1 unit in the remaining domain.
Time frame: Week16
Percentage of subjects with treatment-emergent adverse events (TEAEs) during the study.
Time frame: Baseline to Week20
Percentage of subjects with treatment-emergent serious adverse events (SAEs) during the study.
Time frame: Baseline to Week20
Percentage of subjects who achieve SpondyloArthritis International Society 40% improvement (ASAS40) response at Week 16.
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global, pain, function (assessed by BASFI) and inflammation (mean of Ankylosing Spondylitis Disease Activity Index \[BASDAI\] question 5 and 6 ). ASAS40 response is defined as improvement of ≥40% and ≥2 units in at least 3 domains (on a scale of 0 \[least\] to 10 \[worst\]) and no worsening in the remaining domain.
Time frame: Week 16
Percentage of subjects who achieve ASAS20 response at each visit from baseline.
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global, pain, function (assessed by BASFI) and inflammation (mean of Ankylosing Spondylitis Disease Activity Index \[BASDAI\] question 5 and 6 ). ASAS20 response is defined as improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 \[least\] to 10 \[worst\]) and no worsening of ≥20% and ≥1 unit in the remaining domain.
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Peking University Shougang hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Xuanwu hospital capital medical university
Beijing, Beijing Municipality, China
Guangdong provincial people's hospital
Guangzhou, Guangdong, China
Nanfang Hospital
Guangzhou, Guangdong, China
The first affiliated hospital of Zhengzhou University
Zhengzhou, Henan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower hospital
Nanjing, Jiangsu, China
...and 5 more locations
Time frame: Baseline to Week 20
Percentage of subjects who achieve ASAS40 at each visit from baseline.
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global, pain, function (assessed by BASFI) and inflammation (mean of Ankylosing Spondylitis Disease Activity Index \[BASDAI\] question 5 and 6 ). ASAS40 response is defined as improvement of ≥40% and ≥2 units in at least 3 domains (on a scale of 0 \[least\] to 10 \[worst\]) and no worsening in the remaining domain.
Time frame: Baseline to Week 20
Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at each visit from baseline.
The Ankylosing Spondylitis Quality of Life (ASQoL), a validated disease-specific 18-item questionnaire, has been developed specifically for measuring health-related quality of life (HRQoL) in subjects with ankylosing spondylitis (AS) . The ASQoL score ranges from 0 to 18 with a higher score indicating worse HRQoL.
Time frame: Baseline to Week 20
pharmacodynamics(PD) parameters: Changes of Interleukin-17A (IL-17A) level in peripheral serum compared with baseline and its relationship with AK111 exposure.
Time frame: Baseline to Week 20
Immunogenicity: Number and percentage of subjects with detectable anti-AK111 antibody (ADA).
Time frame: Baseline to Week 20
Change from baseline on the 36-item Short-Form (SF-36) Health Survey at each visit from baseline.
The SF-36 is a 36-item generic health status measure. It measures 8 general health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Each of the 8 domain scores and the component summary scores range from 0 to 100, with higher scores indicating better health status.
Time frame: Baseline to Week 20
Area under the curve from 0 to the time of the last quantifiable concentration (AUC0-t)
Time frame: Baseline to Week 20
Maximum observed concentration (Cmax)
Time frame: Baseline to Week 20
Terminal elimination half-life (T1/2)
Time frame: Baseline to Week 20
Time of occurrence of Cmax (Tmax)
Time frame: Baseline to Week 20