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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02985983
Recruitment Status : Completed
First Posted : December 7, 2016
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Axial Spondyloarthritis Drug: KHK4827 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 7, 2017
Actual Primary Completion Date : September 23, 2019
Actual Study Completion Date : September 23, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Brodalumab

Arm Intervention/treatment
Experimental: KHK4827
KHK4827 administered SC
Drug: KHK4827
Administered KHK4827 by subcutaneous (SC) injection until week 66.
Other Name: Brodalumab

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




Primary Outcome Measures :
  1. Percentage of ASAS 40 in axSpA subjects [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. Percentage of ASAS 40 in AS subjects [ Time Frame: Week 16 ]
  2. Percentage of ASAS 40 in nr-axSpA subjects [ Time Frame: Week 16 ]
  3. Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP change from baseline in axSpA subjects [ Time Frame: Week 16 ]
  4. Number of adverse events [ Time Frame: Up to week 68 ]
  5. Number of patients exposed to anti-KHK4827 antibodies [ Time Frame: Pre-dose,Week 16,Week 32,Week 48,Week 68 or End of study ]
  6. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985983


Locations
Show Show 48 study locations
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.
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Responsible Party: Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier: NCT02985983    
Other Study ID Numbers: 4827-006
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kyowa Kirin Co., Ltd.:
Brodalumab
KHK4827
Axial Spondyloarthritis
Additional relevant MeSH terms:
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Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Brodalumab
Dermatologic Agents