Clinical trial NCT02985983: A Study of Brodalumab in Subjects With Axial Spondyloarthritis (axSpA)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Axial Spondyloarthritis
Keywords: Brodalumab
Axial Spondyloarthritis
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-12-07
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

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 (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)

Primary outcomes:
measure: Percentage of ASAS 40 in axSpA subjects
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of ASAS 40 in AS subjects
timeFrame: Week 16
measure: Percentage of ASAS 40 in nr-axSpA subjects
timeFrame: Week 16
measure: Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP change from baseline in axSpA subjects
timeFrame: Week 16
measure: Number of adverse events
timeFrame: Up to week 68
measure: Number of patients exposed to anti-KHK4827 antibodies
timeFrame: Pre-dose,Week 16,Week 32,Week 48,Week 68 or End of study
measure: Serum KHK4827 concentration
timeFrame: pre-dose、Week 1、Week 2、Week 4、Week 8、Week 12、Week 14、Week 16、Week 24、Week 28、Week 32
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Fujita Health University Hpspital
city: Chiba
country: Japan
facility: Tokyo Women's Medical University Yachiyo Medical Center
city: Fukuoka
country: Japan
facility: Chihaya Hospital
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Fukuoka
country: Japan
facility: Kyusyu University Hospital
city: Hokkaido
country: Japan
facility: Hokkaido University Hospital
city: Hokkaido
country: Japan
facility: Katayama Seikeigeka Rheumatism Clinic
city: Hyogo
country: Japan
facility: Hyogo College of Medicine
city: Kagawa
country: Japan
facility: Kagawa University Hospital
city: Kochi
country: Japan
facility: Kochi Medical School Hospital
city: Nagasaki
country: Japan
facility: Sasebo Chuo Hospital
city: Nara
country: Japan
facility: Tenri Hospital
city: Okayama
country: Japan
facility: Okayama Saiseikai Outpatient Centerl Hospital
city: Okinawa
country: Japan
facility: Okinawa Prefectural Chubu Hospital
city: Okinawa
country: Japan
facility: Tomishiro Central Hospital
city: Osaka
country: Japan
facility: National Hosptal Organization Osaka Minami Medical Center
city: Osaka
country: Japan
facility: Osaka City General Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Osaka
country: Japan
facility: Yukioka Hospital
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Tokyo
country: Japan
facility: St.Luke's International Hospital
city: Tokyo
country: Japan
facility: Toho University Ohashi Medical Center
city: Tokyo
country: Japan
facility: Toho University Omori Medical Center
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: KyungHee University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The catholic university of korea Seoul St.mary's Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Cathay General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation, LinKou Chang Gung Memorial Hospital
Study officials:
References:
citation: 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.
citation: 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.