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

Primary Purpose

Axial Spondyloarthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
KHK4827
Placebo
Sponsored by
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Axial Spondyloarthritis focused on measuring Brodalumab, KHK4827, Axial Spondyloarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Fujita Health University Hpspital
  • Tokyo Women's Medical University Yachiyo Medical Center
  • Chihaya Hospital
  • Fukuoka University Hospital
  • Kyusyu University Hospital
  • Hokkaido University Hospital
  • Katayama Seikeigeka Rheumatism Clinic
  • Hyogo College of Medicine
  • Kagawa University Hospital
  • Kochi Medical School Hospital
  • Sasebo Chuo Hospital
  • Tenri Hospital
  • Okayama Saiseikai Outpatient Centerl Hospital
  • Okinawa Prefectural Chubu Hospital
  • Tomishiro Central Hospital
  • National Hosptal Organization Osaka Minami Medical Center
  • Osaka City General Hospital
  • Osaka City University Hospital
  • Osaka University Hospital
  • Yukioka Hospital
  • Juntendo University Hospital
  • St.Luke's International Hospital
  • Toho University Ohashi Medical Center
  • Toho University Omori Medical Center
  • Tokyo Women's Medical University Hospital
  • Pusan National University Hospital
  • Daegu Catholic University Medical Center
  • Chungnam National University Hospital
  • Chonnam National University Hospital
  • Ajou University Hospital
  • Seoul National University Bundang Hospital
  • Inha University Hospital
  • Hanyang University Seoul Hospital
  • Konkuk University Medical Center
  • KyungHee University Hospital
  • Seoul National University Hospital
  • The catholic university of korea Seoul St.mary's Hospital
  • Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung Veterans General Hospital
  • China Medical University Hospital
  • Chung Shan Medical University Hospital
  • Taichung Veterans General Hospital
  • National Cheng Kung University Hospital
  • Cathay General Hospital
  • National Taiwan University Hospital
  • Tri-Service General Hospital
  • Chang Gung Medical Foundation, LinKou Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

KHK4827

Placebo

Arm Description

KHK4827 administered SC

Placebo administered SC

Outcomes

Primary Outcome Measures

Percentage of ASAS 40 in axSpA subjects

Secondary Outcome Measures

Percentage of ASAS 40 in AS subjects
Percentage of ASAS 40 in nr-axSpA subjects
Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP change from baseline in axSpA subjects
Number of adverse events
Number of patients exposed to anti-KHK4827 antibodies
Serum KHK4827 concentration

Full Information

First Posted
December 5, 2016
Last Updated
March 2, 2020
Sponsor
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02985983
Brief Title
A Study of KHK4827 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 KHK4827 in Subjects With Axial Spondyloarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 7, 2017 (Actual)
Primary Completion Date
September 23, 2019 (Actual)
Study Completion Date
September 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axial Spondyloarthritis
Keywords
Brodalumab, KHK4827, Axial Spondyloarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KHK4827
Arm Type
Experimental
Arm Description
KHK4827 administered SC
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC
Intervention Type
Drug
Intervention Name(s)
KHK4827
Other Intervention Name(s)
Brodalumab
Intervention Description
Administered KHK4827 by subcutaneous (SC) injection until week 66.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered Placebo by subcutaneous (SC) injection until week 16. Administered KHK4827 by SC injection from week 17 until week 66.
Primary Outcome Measure Information:
Title
Percentage of ASAS 40 in axSpA subjects
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of ASAS 40 in AS subjects
Time Frame
Week 16
Title
Percentage of ASAS 40 in nr-axSpA subjects
Time Frame
Week 16
Title
Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP change from baseline in axSpA subjects
Time Frame
Week 16
Title
Number of adverse events
Time Frame
Up to week 68
Title
Number of patients exposed to anti-KHK4827 antibodies
Time Frame
Pre-dose,Week 16,Week 32,Week 48,Week 68 or End of study
Title
Serum KHK4827 concentration
Time Frame
pre-dose、Week 1、Week 2、Week 4、Week 8、Week 12、Week 14、Week 16、Week 24、Week 28、Week 32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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)
Facility Information:
Facility Name
Fujita Health University Hpspital
City
Aichi
Country
Japan
Facility Name
Tokyo Women's Medical University Yachiyo Medical Center
City
Chiba
Country
Japan
Facility Name
Chihaya Hospital
City
Fukuoka
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka
Country
Japan
Facility Name
Kyusyu University Hospital
City
Fukuoka
Country
Japan
Facility Name
Hokkaido University Hospital
City
Hokkaido
Country
Japan
Facility Name
Katayama Seikeigeka Rheumatism Clinic
City
Hokkaido
Country
Japan
Facility Name
Hyogo College of Medicine
City
Hyogo
Country
Japan
Facility Name
Kagawa University Hospital
City
Kagawa
Country
Japan
Facility Name
Kochi Medical School Hospital
City
Kochi
Country
Japan
Facility Name
Sasebo Chuo Hospital
City
Nagasaki
Country
Japan
Facility Name
Tenri Hospital
City
Nara
Country
Japan
Facility Name
Okayama Saiseikai Outpatient Centerl Hospital
City
Okayama
Country
Japan
Facility Name
Okinawa Prefectural Chubu Hospital
City
Okinawa
Country
Japan
Facility Name
Tomishiro Central Hospital
City
Okinawa
Country
Japan
Facility Name
National Hosptal Organization Osaka Minami Medical Center
City
Osaka
Country
Japan
Facility Name
Osaka City General Hospital
City
Osaka
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
Country
Japan
Facility Name
Osaka University Hospital
City
Osaka
Country
Japan
Facility Name
Yukioka Hospital
City
Osaka
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo
Country
Japan
Facility Name
St.Luke's International Hospital
City
Tokyo
Country
Japan
Facility Name
Toho University Ohashi Medical Center
City
Tokyo
Country
Japan
Facility Name
Toho University Omori Medical Center
City
Tokyo
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Tokyo
Country
Japan
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Daegu Catholic University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Hanyang University Seoul Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
KyungHee University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The catholic university of korea Seoul St.mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
Cathay General Hospital
City
Taipei
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
Country
Taiwan
Facility Name
Chang Gung Medical Foundation, LinKou Chang Gung Memorial Hospital
City
Taoyuan
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36130275
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.
Results Reference
derived
PubMed Identifier
33827787
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.
Results Reference
derived

Learn more about this trial

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

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