Axial Spondyloarthritis (axSpA)
Conditions
Interventions
investigational material(s)
Generic name etc : Brodalumab
INN of investigational material : brodalumab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for
Sponsors
Kyowa Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Subject with age at onset = 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
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 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 |
|---|---|
| efficacy Percetage of ASAS 40 at week 16 in axSpA subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy - ASAS 20 at week 16 in axSpA subjects - ASAS 40 at week 16 in Ankylosing Spondylitis subjects - ASAS 40 at week 16 in non-radiographic axSpA subjects - Ankylosing Spondylitis Disease Activity Score /C-Reactive Protein change from baseline at week 16 in axSpA subjects safety - Adverse events - Anti-Brodalumab antibodies - Serum Brodalumab concentration | — |
Countries
Asia except Japan, Japan
Outcome results
None listed