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

July 15, 2024 updated by: Kyowa Kirin Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan
        • Fujita Health University Hpspital
      • Chiba, Japan
        • Tokyo Women's Medical University Yachiyo Medical Center
      • Fukuoka, Japan
        • Fukuoka University Hospital
      • Fukuoka, Japan
        • Chihaya Hospital
      • Fukuoka, Japan
        • Kyusyu University Hospital
      • Hokkaido, Japan
        • Hokkaido University Hospital
      • Hokkaido, Japan
        • Katayama Seikeigeka Rheumatism Clinic
      • Hyogo, Japan
        • Hyogo College of Medicine
      • Kagawa, Japan
        • Kagawa University Hospital
      • Kochi, Japan
        • Kochi Medical School Hospital
      • Nagasaki, Japan
        • Sasebo Chuo Hospital
      • Nara, Japan
        • Tenri Hospital
      • Okayama, Japan
        • Okayama Saiseikai Outpatient Centerl Hospital
      • Okinawa, Japan
        • Okinawa Prefectural Chubu Hospital
      • Okinawa, Japan
        • Tomishiro Central Hospital
      • Osaka, Japan
        • Osaka City General Hospital
      • Osaka, Japan
        • Osaka University Hospital
      • Osaka, Japan
        • National Hosptal Organization Osaka Minami Medical Center
      • Osaka, Japan
        • Osaka City University Hospital
      • Osaka, Japan
        • Yukioka Hospital
      • Tokyo, Japan
        • Toho University Ohashi Medical Center
      • Tokyo, Japan
        • Juntendo University Hospital
      • Tokyo, Japan
        • St.Luke's International Hospital
      • Tokyo, Japan
        • Toho University Omori Medical Center
      • Tokyo, Japan
        • Tokyo Women's Medical University Hospital
  • Korea, Republic of
      • Busan, Korea, Republic of
        • Pusan National University Hospital
      • Daegu, Korea, Republic of
        • Daegu Catholic University Medical Center
      • Daejeon, Korea, Republic of
        • Chungnam National University Hospital
      • Gwangju, Korea, Republic of
        • Chonnam National University Hospital
      • Gyeonggi-do, Korea, Republic of
        • Ajou University Hospital
      • Gyeonggi-do, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Incheon, Korea, Republic of
        • Inha University Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of
        • The Catholic University of Korea Seoul St.Mary's Hospital
      • Seoul, Korea, Republic of
        • KyungHee University Hospital
      • Seoul, Korea, Republic of
        • Hanyang University Seoul Hospital
  • Taiwan
      • Kaohsiung, Taiwan
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung, Taiwan
        • Kaohsiung Veterans General Hospital
      • Kaohsiung, Taiwan
        • Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital
      • Taichung, Taiwan
        • China Medical University Hospital
      • Taichung, Taiwan
        • Taichung Veterans General Hospital
      • Taichung, Taiwan
        • Chung Shan Medical University Hospital
      • Tainan, Taiwan
        • National Cheng Kung University Hospital
      • Taipei, Taiwan
        • Tri-Service General Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Cathay General Hospital
      • Taoyuan, Taiwan
        • Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo administered SC
Drug: Placebo
Administered Placebo by subcutaneous (SC) injection until week 16. Administered Brodalumab by SC injection from week 17 until week 66.
Experimental: Brodalumab
Brodalumab administered SC
Drug: Brodalumab
Administered Brodalumab by subcutaneous (SC) injection until week 66.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of ASAS 40 in axSpA subjects
Time Frame: Week 16
Week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of ASAS 40 in AS subjects
Time Frame: Week 16
Week 16
Percentage of ASAS 40 in nr-axSpA subjects
Time Frame: Week 16
Week 16
Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP change from baseline in axSpA subjects
Time Frame: Week 16
Week 16
Number of adverse events
Time Frame: Up to week 68
Up to week 68
Number of patients exposed to anti-KHK4827 antibodies
Time Frame: Pre-dose,Week 16,Week 32,Week 48,Week 68 or End of study
Pre-dose,Week 16,Week 32,Week 48,Week 68 or End of study
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
pre-dose、Week 1、Week 2、Week 4、Week 8、Week 12、Week 14、Week 16、Week 24、Week 28、Week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2017

Primary Completion (Actual)

September 23, 2019

Study Completion (Actual)

September 23, 2019

Study Registration Dates

First Submitted

December 5, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (Estimated)

December 7, 2016

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 15, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4827-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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