A Study of Brodalumab in Subjects With Axial Spondyloarthritis (axSpA)
NCT ID: NCT02985983
Last Updated: 2024-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
159 participants
INTERVENTIONAL
2017-03-07
2019-09-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Efficacy and Safety of Brodalumab Compared With Placebo in Subjects With Axial Spondyloarthritis
NCT02429882
Efficacy and Influencing Factors of Secukinumab in Patients With Axial Spondyloarthritis
NCT07130331
A Trial of SHR-1314 Injection in Adult Patients With Active Non-radiographic Axial Spondyloarthritis
NCT06860750
Evaluate the Preliminary Efficacy, Safety, and PK of Subcutaneous JS005 in Chinese Adult Patients With Active Nr-axSpA
NCT05242588
A Phase III Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis
NCT06378697
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Brodalumab
Brodalumab administered SC
Brodalumab
Administered Brodalumab by subcutaneous (SC) injection until week 66.
Placebo
Placebo administered SC
Placebo
Administered Placebo by subcutaneous (SC) injection until week 16. Administered Brodalumab by SC injection from week 17 until week 66.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Brodalumab
Administered Brodalumab by subcutaneous (SC) injection until week 66.
Placebo
Administered Placebo by subcutaneous (SC) injection until week 16. Administered Brodalumab by SC injection from week 17 until week 66.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Hyōgo, , Japan
Kagawa University Hospital
Kagawa, , Japan
Kochi Medical School Hospital
Kochi, , Japan
Sasebo Chuo Hospital
Nagasaki, , Japan
Tenri Hospital
Nara, , Japan
Okayama Saiseikai Outpatient Centerl Hospital
Okayama, , Japan
Okinawa Prefectural Chubu Hospital
Okinawa, , Japan
Tomishiro Central Hospital
Okinawa, , Japan
National Hosptal Organization Osaka Minami Medical Center
Osaka, , Japan
Osaka City General Hospital
Osaka, , Japan
Osaka City University Hospital
Osaka, , Japan
Osaka University Hospital
Osaka, , Japan
Yukioka Hospital
Osaka, , Japan
Juntendo University Hospital
Tokyo, , Japan
St.Luke's International Hospital
Tokyo, , Japan
Toho University Ohashi Medical Center
Tokyo, , Japan
Toho University Omori Medical Center
Tokyo, , Japan
Tokyo Women's Medical University Hospital
Tokyo, , Japan
Pusan National University Hospital
Busan, , South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Ajou University Hospital
Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Inha University Hospital
Incheon, , South Korea
Hanyang University Seoul Hospital
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
KyungHee University Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
The catholic university of korea Seoul St.mary's Hospital
Seoul, , South Korea
Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Cathay General Hospital
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation, LinKou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kim TH, Kishimoto M, Wei JC, Jeong H, Nozaki A, Kobayashi S. Brodalumab, an anti-interleukin-17 receptor A monoclonal antibody, in axial spondyloarthritis: 68-week results from a phase 3 study. Rheumatology (Oxford). 2023 May 2;62(5):1851-1859. doi: 10.1093/rheumatology/keac522.
Wei JC, Kim TH, Kishimoto M, Ogusu N, Jeong H, Kobayashi S; 4827-006 study group. Efficacy and safety of brodalumab, an anti-IL17RA monoclonal antibody, in patients with axial spondyloarthritis: 16-week results from a randomised, placebo-controlled, phase 3 trial. Ann Rheum Dis. 2021 Aug;80(8):1014-1021. doi: 10.1136/annrheumdis-2020-219406. Epub 2021 Apr 7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
4827-006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.