A Study of Brodalumab in Subjects With Axial Spondyloarthritis (axSpA)
- Registration Number
- NCT02985983
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 159
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo administered SC Brodalumab Brodalumab Brodalumab administered SC
- Primary Outcome Measures
Name Time Method Percentage of ASAS 40 in axSpA subjects Week 16
- Secondary Outcome Measures
Name Time Method Percentage of ASAS 40 in nr-axSpA 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 Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP change from baseline in axSpA subjects Week 16 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 Percentage of ASAS 40 in AS subjects Week 16
Trial Locations
- Locations (48)
Fujita Health University Hpspital
🇯🇵Aichi, Japan
Tokyo Women's Medical University Yachiyo Medical Center
🇯🇵Chiba, Japan
Chihaya Hospital
🇯🇵Fukuoka, Japan
Fukuoka University Hospital
🇯🇵Fukuoka, Japan
Kyusyu University Hospital
🇯🇵Fukuoka, Japan
Hokkaido University Hospital
🇯🇵Hokkaido, Japan
Katayama Seikeigeka Rheumatism Clinic
🇯🇵Hokkaido, Japan
Hyogo College of Medicine
🇯🇵Hyogo, Japan
Kagawa University Hospital
🇯🇵Kagawa, Japan
Kochi Medical School Hospital
🇯🇵Kochi, Japan
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