Clinical Trials List
2017-01-01 - 2020-06-30
Phase III
Terminated11
ICD-10M47.9
Spondylosis, unspecified
ICD-10M46.90
Unspecified inflammatory spondylopathy, site unspecified
ICD-10M47
Spondylosis
ICD-9720.0
Ankylosing spondylitis
A Phase 3 Multicenter, Randomized, Double-blind,Placebo-controlled Study with an Open Label Extension to Evaluatethe Efficacy and Safety of KHK4827 in Subjects with Axial Spondyloarthritis
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Trial Applicant
Linical
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Sponsor
Kyowa Kirin Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Po-Hao Huang 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 梁培英 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 吳俊欣 Division of Rheumatology
- Chia-Tse Weng Division of Rheumatology
- 林峻宇 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Jeng-Hsien Yen Division of Rheumatology
- 吳正欽 Division of Rheumatology
- 歐燦騰 Division of Rheumatology
- Sung Wan-Yu Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 林靖才 Division of Rheumatology
- 謝佳偉 Division of Rheumatology
- WEN-NAN HUANG Division of Rheumatology
- Yi-Ming Chen Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Yao-Fan Fang 風濕免疫科
- 張哲慈 風濕免疫科
- TianMing Zhan 風濕免疫科
- Ping-Han Tsai 風濕免疫科
- Chang-Fu Kuo 風濕免疫科
- 陳彥輔 風濕免疫科
The Actual Total Number of Participants Enrolled
8 Terminated
Audit
None
Co-Principal Investigator
- Wen Chan Tsai 未分科
Audit
None
Co-Principal Investigator
- KO-JEN LI 風濕免疫科
- 郭佑民 風濕免疫科
- CHIEH-YU SHEN 風濕免疫科
- SONG-CHOU HSIEH 風濕免疫科
- CHIH-WEI YU 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
• ASAS 40 at week 16 in axSpA (AS and nr-axSpA) subjects
Secondary Endpoints:
• ASAS 20 at week 16 in axSpA (AS and nr-axSpA) subjects
• ASAS 40 at week 16 in AS subjects
• ASAS 40 at week 16 in nr-axSpA subjects
• ASDAS-CRP change from baseline at week 16 in axSpA subjects
Inclution Criteria
1) Personally submitted written voluntary informed consent to participate in the study (if
a minor at the time of consent, written informed consent must be obtained from his or
her legally acceptable representative as well)
2) Aged ≥ 18 years at the time of consent (the cut-off age depends on the local law)
3) Subject fulfills the ASAS classification criteria of axial spondyloarthritis (with the
exception of the Crohn's disease criterion) for > 3 months
AS subjects: Subject has radiographic evidence of sacroiliitis grade ≥ 2 bilaterally or
grade 3 to 4 unilaterally (image must have been obtained ≤ 6 months from time of
screening; centrally read)
OR
nr-axSpA subjects: Subject does not have radiographic evidence of sacroiliitis grade ≥
2 bilaterally or grade 3 to 4 unilaterally (image must have been obtained ≤ 6 months
from time of screening; centrally read)
AND
presence of inflammatory lesions of sacroiliac joint on MRI of Spondyloarthritis
Research Consortium of Canada (SPARCC) level ≥ 2 (centrally read)
4) Subject has Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4
at screening and enrollment
5) Subject has spinal pain score (BASDAI question #2) ≥ 4 at screening and enrollment
6) Subject has had adequate therapy of non-steroidal anti-inflammatory drugs (NSAIDs)
for at least 3 months.
7) For subjects receiving non-biologic DMARDs (methotrexate or sulfasalazine): the
subject has received treatment for ≥ 3 months, with a stable dose for ≥ 4 weeks prior
to initiation of investigational product.
8) For subject receiving oral corticosteroids: the subject has received treatment for ≥ 4
weeks prior to initiation of investigational product.
9) No findings in chest X-ray (or chest computed tomography (CT) scan) suggestive of
active tuberculosis, meeting any of the following criteria at screening:
• Negative QuantiFERON or T-spot test
• “Borderline” or “invalid” result of QuantiFERON or T-spot test, and negative
result in re-testing
• “Borderline” result in re-testing QuantiFERON or T-spot test, and taking antituberculosis agents (isoniazid, as a general rule) on a regular basis since at least 3
weeks before the start of investigational product administration
• Positive result in QuantiFERON or T-spot test (including retest), but no findings in
chest CT scan suggestive of active tuberculosis, and taking anti-tuberculosis
agents(isoniazid, as a general rule) on a regular basis since at least 3 weeks before
the start of investigational product administration
Exclusion Criteria
1) Complete ankylosis (fusion) of the spine
2) 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
3) Subject has a planned surgical intervention between enrollment and week 16
4) Subject has an active infection or history of infections as follows:
• any active infection for which systemic anti-infectives were used within 28 days
prior to the first investigational product administration
• a serious infection, defined as requiring hospitalization or intravenous antiinfectives within 8 weeks prior to the first investigational product administration
• recurrent or chronic infections or other active infection that, in the opinion of the
investigators, might cause this study to be detrimental to the subject
5) Subject has any systemic disease (e.g., renal failure, heart failure, hypertension, liver
disease, diabetes, anemia) considered by the investigators to be clinically significant
and uncontrolled.
6) Subject has a known history of human immunodeficiency virus infection
7) Subject has positive result in any item of infection tests (hepatitis B surface [HBs]
antigen, HBs antibody, hepatitis B core [HBc] antibody, hepatitis C virus [HCV]
antibody, human immunodeficiency virus [HIV] antigen/antibody, or Human Tlymphotropic virus type 1 [HTLV-1] antibody) with the exception of the following
cases:
• Subjects negative for HBs antigen and positive for HBc antibody and/or HBs
antibody, and with a hepatitis B virus DNA (HBV-DNA) level below the detection
sensitivity (such subjects are required to undergo the HBV-DNA assay at 4-week
intervals). However, HBV-DNA measurement will not be required for subjects
who are positive for antibodies produced after HB vaccination and who are not
affected with hepatitis B at screening.
8) Subject had myocardial infarction, unstable angina pectoris or stroke within the past
12 months prior to the first investigational product administration
9) Subject has any active malignancy, including evidence of cutaneous basal or
squamous cell carcinoma or melanoma.
10) Subject has a history of malignancy within 5 years prior to enrollment EXCEPT
treated and considered cured cutaneous basal or squamous cell carcinoma, in situ
cervical cancer or in situ breast ductal carcinoma
11) Subject has any concurrent medical condition or electrocardiogram (ECG)
abnormality that, in the opinion of the investigators, could cause this study to be
detrimental to the subject.
12) Subject has a history of Crohn's disease
13) Subject has any of the following laboratory abnormalities at screening:
• aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 × the
upper limit of normal (ULN)
• serum direct bilirubin ≥ 1.5 mg/dL (25.7 μmol/L)
• white blood cell (WBC) count < 3000/μL
• neutrophil count < 2000/μL
14) Subject has any other laboratory abnormality, which, in the opinion of the
investigators, will prevent the subject from completing the study or will interfere with
the interpretation of the study results
15) Subject has used DMARDs other than a stable dose of methotrexate or sulfasalazine,
or has received live vaccine (s) within 28 days of the first dose of investigational
product
16) Subject has used any narcotic analgesics (excluding tramadol) or medical marijuana
within 1 week prior to enrollment
17) Subject has a prior history of >1 anti-TNF therapy
18) Subject has used commercially available or investigational biologic therapies as
follows:
• anti-TNF therapy as follows: within 1 month prior to investigational product
initiation for adalimumab or etanercept, and within 2 months prior to
investigational product initiation for other anti-TNF agents.
• anti-IL-17 biologics (e.g., brodalumab, secukinumab, ixekizumab)
• anti-IL-12/IL-23 biologic therapy (e.g., ustekinumab, briakinumab) within 6
months prior to investigational product initiation
19) Subject has a history of treatment with any corticosteroids (other than oral
corticosteroids) within 4 weeks before the start of investigational product
administration.
20) Subject has treated in a clinical study with an investigational product other than
KHK4827 or with an unapproved medical device within 4 months before
investigational product administration in this study
21) Subject has planned participation in another clinical study during this study.
22) Subject has known sensitivity to any of the products or components to be
administered during dosing.
23) Subject is not likely to complete all protocol-required study visits or procedures,
and/or to comply with all required study procedures to the best of the subject and
investigator's knowledge.
24) 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
25) Subject has a history or evidence of a psychiatric disorder, alcohol and/or substance
abuse, or any other mental health disorder that, in the opinion of the investigators,
would pose a risk to subject safety or interfere with the study evaluation, procedures
or completion.
26) 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).
27) Subject has a history or evidence of any other clinically significant disorder, condition
or disease (with the exception of those outlined above) that, in the opinion of the
investigators would pose a risk to subject safety or interfere with the study evaluation,
procedures or completion.
28) Pregnant or lactating women or women who are willing to have a child within 8
weeks after the last dose of the investigational product.
29) Women of child-bearing potential (except for permanently sterilized, postmenopausal
[defined as amenorrhea ≥ 12 consecutive months without an alternative medical
cause] or anatomically not of childbearing potential) with a positive pregnancy test
(assessed by a serum pregnancy test during screening and a urine pregnancy test at
enrollment).
30) Women of child-bearing potential who do not agree to use effective contraception
from the day of providing consent through 8 weeks after the last dose of
investigational product. Fertile men who do not agree to use effective contraception
from the day of first dose of investigational product through 8 weeks after the last
dose of investigational product. Effective contraception is defined as using any two of
the following methods: condom, oral contraceptives, intrauterine contraceptive device,
and diaphragm, or practice true abstinence from sexual intercourse. The investigators
will thoroughly explain the risks in pregnancy and the effective contraceptive
methods to the subjects.
31) Anyone otherwise considered unsuitable for the study by the investigators
The Estimated Number of Participants
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Taiwan
85 participants
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Global
120 participants
