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 Number of adverse events Up to week 68 Percentage of ASAS 40 in AS subjects Week 16 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
Trial Locations
- Locations (48)
Tenri Hospital
🇯🇵Nara, Japan
Fukuoka University Hospital
🇯🇵Fukuoka, Japan
Kyusyu University Hospital
🇯🇵Fukuoka, Japan
Katayama Seikeigeka Rheumatism Clinic
🇯🇵Hokkaido, Japan
Kagawa University Hospital
🇯🇵Kagawa, Japan
Juntendo University Hospital
🇯🇵Tokyo, Japan
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Cathay General Hospital
🇨🇳Taipei, Taiwan
Osaka City General Hospital
🇯🇵Osaka, Japan
Osaka City University Hospital
🇯🇵Osaka, Japan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
Fujita Health University Hpspital
🇯🇵Aichi, Japan
Kochi Medical School Hospital
🇯🇵Kochi, Japan
Okayama Saiseikai Outpatient Centerl Hospital
🇯🇵Okayama, Japan
Toho University Omori Medical Center
🇯🇵Tokyo, Japan
Tokyo Women's Medical University Hospital
🇯🇵Tokyo, Japan
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Tokyo Women's Medical University Yachiyo Medical Center
🇯🇵Chiba, Japan
Chihaya Hospital
🇯🇵Fukuoka, Japan
Sasebo Chuo Hospital
🇯🇵Nagasaki, Japan
Okinawa Prefectural Chubu Hospital
🇯🇵Okinawa, Japan
Tomishiro Central Hospital
🇯🇵Okinawa, Japan
St.Luke's International Hospital
🇯🇵Tokyo, Japan
Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Osaka University Hospital
🇯🇵Osaka, Japan
Yukioka Hospital
🇯🇵Osaka, Japan
Ajou University Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
China Medical University Hospital
🇨🇳Taichung, Taiwan
KyungHee University Hospital
🇰🇷Seoul, Korea, Republic of
The catholic university of korea Seoul St.mary's Hospital
🇰🇷Seoul, Korea, Republic of
Hokkaido University Hospital
🇯🇵Hokkaido, Japan
Hyogo College of Medicine
🇯🇵Hyogo, Japan
National Hosptal Organization Osaka Minami Medical Center
🇯🇵Osaka, Japan
Toho University Ohashi Medical Center
🇯🇵Tokyo, Japan
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung, Taiwan
Chang Gung Medical Foundation, LinKou Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of