Axial Spondyloarthritis
Conditions
Keywords
Brodalumab, Axial Spondyloarthritis
Brief summary
To evaluate the efficacy of Brodalumab in axSpA (ankylosing spondylitis \[AS\] and non-radiographic axial spondyloarthritis \[nr-axSpA\]) subjects compared to placebo, as measured by the proportion of axSpA subjects achieving an Assessment of SpondyloArthritis international Society (ASAS) 40 response at week 16.
Interventions
DRUGBrodalumab
Administered Brodalumab by subcutaneous (SC) injection until week 66.
DRUGPlacebo
Administered Placebo by subcutaneous (SC) injection until week 16. Administered Brodalumab by SC injection from week 17 until week 66.
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject with age at onset \<45 years and continuous chronic back pain for ≥ 3 months fulfills the ASAS classification criteria of axial spondyloarthritis (with the exception of the Crohn's disease) * Subject has Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 at screening and enrollment * Subject has spinal pain score (BASDAI question #2) ≥ 4 at screening and enrollment * Subject has had adequate therapy with non-steroidal anti-inflammatory drugs (oral NSAIDs) for back pain for at least 3 months with inadequate treatment response before enrollment
Exclusion criteria
* Complete ankylosis (fusion) of the spine * Subject with active ongoing inflammatory diseases other than axSpA that might confound the evaluation of Brodalumab therapy, including reactive arthritis, spondyloarthritis associated with inflammatory bowel disease, SAPHO syndrome (pustulotic arthro-osteitis), fibromyalgia, ankylosing spinal hyperostosis, osteitis condensans ilii, spondylosis deformans, or osteoarthritis sacroiliac joint disease * Subject has a prior history of \>1 anti-tumor necrosis factor (TNF) therapy * Subject has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at enrollment * Subject has a history or evidence of a psychiatric disorder, alcohol and/or substance abuse * Subject has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at enrollment (note: subjects with a total score of 10 to 14 on the PHQ-8 should be referred to a mental health care professional)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of ASAS 40 in axSpA subjects | Week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of ASAS 40 in nr-axSpA subjects | Week 16 |
| Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP change from baseline in axSpA subjects | Week 16 |
| Percentage of ASAS 40 in AS subjects | Week 16 |
| Number of patients exposed to anti-KHK4827 antibodies | Pre-dose,Week 16,Week 32,Week 48,Week 68 or End of study |
| Serum KHK4827 concentration | pre-dose、Week 1、Week 2、Week 4、Week 8、Week 12、Week 14、Week 16、Week 24、Week 28、Week 32 |
| Number of adverse events | Up to week 68 |
Countries
Japan, South Korea, Taiwan
Outcome results
None listed