A Study of KHK4827 in Subjects With Axial Spondyloarthritis (axSpA)
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| ClinicalTrials.gov Identifier: NCT02985983 |
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Recruitment Status :
Completed
First Posted : December 7, 2016
Last Update Posted : March 3, 2020
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Sponsor:
Kyowa Kirin Co., Ltd.
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.
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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 |
| 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 |
|---|---|
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Experimental: KHK4827
KHK4827 administered SC
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Drug: KHK4827
Administered KHK4827 by subcutaneous (SC) injection until week 66.
Other Name: Brodalumab |
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Placebo Comparator: Placebo
Placebo administered SC
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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 :
- Percentage of ASAS 40 in axSpA subjects [ Time Frame: Week 16 ]
Secondary Outcome Measures :
- Percentage of ASAS 40 in AS subjects [ Time Frame: Week 16 ]
- Percentage of ASAS 40 in nr-axSpA subjects [ Time Frame: Week 16 ]
- Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP change from baseline in axSpA subjects [ Time Frame: Week 16 ]
- Number of adverse events [ Time Frame: 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 ]
- 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 ]
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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 48 study locations
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| 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.:
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Brodalumab KHK4827 Axial Spondyloarthritis |
Additional relevant MeSH terms:
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Spondylitis Spondylarthritis Bone Diseases, Infectious Infections Bone Diseases Musculoskeletal Diseases |
Spinal Diseases Arthritis Joint Diseases Brodalumab Dermatologic Agents |