A Study of Brodalumab in Subjects With Axial Spondyloarthritis (axSpA)
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open Label Extension to Evaluate the Efficacy and Safety of Brodalumab in Subjects With Axial Spondyloarthritis
1 other identifier
interventional
159
3 countries
48
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2017
Typical duration for phase_3
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2016
CompletedFirst Posted
Study publicly available on registry
December 7, 2016
CompletedStudy Start
First participant enrolled
March 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2019
CompletedJuly 16, 2024
July 1, 2024
2.5 years
December 5, 2016
July 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of ASAS 40 in axSpA subjects
Week 16
Secondary Outcomes (6)
Percentage of ASAS 40 in AS subjects
Week 16
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
Number of adverse events
Up to week 68
Number of patients exposed to anti-KHK4827 antibodies
Pre-dose,Week 16,Week 32,Week 48,Week 68 or End of study
- +1 more secondary outcomes
Study Arms (2)
Brodalumab
EXPERIMENTALBrodalumab administered SC
Placebo
PLACEBO COMPARATORPlacebo administered SC
Interventions
Administered Placebo by subcutaneous (SC) injection until week 16. Administered Brodalumab by SC injection from week 17 until week 66.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
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, 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
Related Publications (2)
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.
PMID: 36130275DERIVEDWei 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.
PMID: 33827787DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2016
First Posted
December 7, 2016
Study Start
March 7, 2017
Primary Completion
September 23, 2019
Study Completion
September 23, 2019
Last Updated
July 16, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share