A Study of KHK4827 in Subjects With Axial Spondyloarthritis (axSpA)

Axial Spondyloarthritis Clinical Trial

Official title:

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open Label Extension to Evaluate the Efficacy and Safety of KHK4827 in Subjects With Axial Spondyloarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02985983
• Other study ID #: 4827-006
• Status: Completed
• Phase: Phase 3
• Start date: March 7, 2017
• Est. completion date: September 23, 2019

Study information

• Verified date: March 2020
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy of KHK4827 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: September 23, 2019
• Est. primary completion date: September 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 KHK4827 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-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)

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis

Intervention

Drug:
• KHK4827
Administered KHK4827 by subcutaneous (SC) injection until week 66.
• Placebo
Administered Placebo by subcutaneous (SC) injection until week 16. Administered KHK4827 by SC injection from week 17 until week 66.

Locations

Country	Name	City	State
Japan	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	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
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Ajou University Hospital	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	KyungHee University Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	The catholic university of korea Seoul St.mary's Hospital	Seoul
Taiwan	Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
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

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of ASAS 40 in axSpA subjects		Week 16
Secondary	Percentage of ASAS 40 in AS subjects		Week 16
Secondary	Percentage of ASAS 40 in nr-axSpA subjects		Week 16
Secondary	Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP change from baseline in axSpA subjects		Week 16
Secondary	Number of adverse events		Up to week 68
Secondary	Number of patients exposed to anti-KHK4827 antibodies		Pre-dose,Week 16,Week 32,Week 48,Week 68 or End of study
Secondary	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