Clinical Trials List
Protocol NumberAC-201-GOU-002
2014-11-03 - 2016-11-01
Phase II
Terminated7
Study ended1
ICD-10M10.9
Gout, unspecified
ICD-9274.9
Gout, unspecified
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF AC 201 IN SUBJECTS WITH GOUT
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Trial Applicant
TWI BIOTECHNOLOGY, INC
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Sponsor
-
Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Wei-Sheng Chen Division of Rheumatology
- C. D. CHOU Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Principal Investigator
Co-Principal Investigator
- 全以祖 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 林幸宜 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 吳詹永嬌 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 洪偉哲 Division of Rheumatology
- Po-Hao Huang Division of Rheumatology
The Actual Total Number of Participants Enrolled
13 Study ended
Condition/Disease
Osteoarthritis
Objectives
Gout is a type of inflammatory arthritis induced by the deposition of monosodium urate
(MSU) crystals in synovial fluid and other tissues. Gout is associated with hyperuricemia,
which is defined as a serum urate level of ≥6.8 mg/dL, the limit of urate solubility at
physiologic temperature and pH. Gout has two clinical phases. The first phase is
characterized by intermittent acute attacks that spontaneously resolve, typically over a period of 7 to 10 days, with asymptomatic periods between attacks. With inadequately treated hyperuricemia, transition to the second phase can occur, manifested as chronic tophaceous gout, which often involves polyarticular attacks, symptoms between attacks, and crystal deposition (tophi) in soft tissues or joints. The long-term gout management strategy of urate-lowering therapy (ULT) is to reduce and maintain serum uric acid (sUA)
concentrations below 6.0 mg/dL to reduce flare risk and prevent long-term complications
Test Drug
AC-201
Active Ingredient
AC-201
Dosage Form
CR
Dosage
100
Endpoints
Primary Efficacy Endpoint:
Proportion of subjects achieving serum uric acid concentration <6.0 mg/dL at Week 8
Secondary Efficacy Endpoints:
Absolute and percent change from baseline in serum uric acid concentration at each visit
Proportion of subjects achieving serum uric acid concentration <6.0 mg/dL or <5.0 mg/dL at each visit
Proportion of subjects experiencing ≥1 gout flare or ≥2 gout flares during each period and overall
Number of gout flares per subject during each period and overall
Time to first gout flare
Proportion of subjects achieving serum uric acid concentration <6.0 mg/dL without a gout flare during each period and overall
Additional Endpoints:
Pain associated with gout flares by visual analog scale score
Gout flare days per subject
Change from baseline in metabolic and inflammation markers
Proportion of subjects achieving serum uric acid concentration <6.0 mg/dL at Week 8
Secondary Efficacy Endpoints:
Absolute and percent change from baseline in serum uric acid concentration at each visit
Proportion of subjects achieving serum uric acid concentration <6.0 mg/dL or <5.0 mg/dL at each visit
Proportion of subjects experiencing ≥1 gout flare or ≥2 gout flares during each period and overall
Number of gout flares per subject during each period and overall
Time to first gout flare
Proportion of subjects achieving serum uric acid concentration <6.0 mg/dL without a gout flare during each period and overall
Additional Endpoints:
Pain associated with gout flares by visual analog scale score
Gout flare days per subject
Change from baseline in metabolic and inflammation markers
Inclution Criteria
Each subject must meet the following criteria to be enrolled in this study.
1. Male or female age 20 to 65 years, inclusive.
2. Meets ≥6 of the 12 American College of Rheumatology preliminary criteria (1977) for
the classification of acute arthritis of primary gout (Appendix 2), OR have proven tophus
or documented monosodium urate (MSU) crystals in the joint fluid.
3. Serum uric acid ≥7.5 mg/dL and ≤10 mg/dL at screening with ≥1 gouty arthritis flare
within one year prior to screening, OR serum uric acid ≥9 mg/dL and ≤10 mg/dL at
screening with or without prior gout flares.
4. Is male, or is female and meets all the following criteria:
a. Not breastfeeding
b. If of childbearing potential (defined as non-post-hysterectomy or non-postmenopausal [≥50 years of age and amenorrheic for at least 1 year]), must have a negative pregnancy test result (human chorionic gonadotropin, beta subunit [hCG]) at Visit 1 (Screening) and Visit 2 (Day 1/Baseline), and must practice and be willing to continue to practice appropriate birth control during the entire duration of the study
5. Is able to read, understand, and sign the Informed Consent Form (ICF), communicate
with the investigator, complete study diaries, and understand and comply with protocol
requirements.
1. Male or female age 20 to 65 years, inclusive.
2. Meets ≥6 of the 12 American College of Rheumatology preliminary criteria (1977) for
the classification of acute arthritis of primary gout (Appendix 2), OR have proven tophus
or documented monosodium urate (MSU) crystals in the joint fluid.
3. Serum uric acid ≥7.5 mg/dL and ≤10 mg/dL at screening with ≥1 gouty arthritis flare
within one year prior to screening, OR serum uric acid ≥9 mg/dL and ≤10 mg/dL at
screening with or without prior gout flares.
4. Is male, or is female and meets all the following criteria:
a. Not breastfeeding
b. If of childbearing potential (defined as non-post-hysterectomy or non-postmenopausal [≥50 years of age and amenorrheic for at least 1 year]), must have a negative pregnancy test result (human chorionic gonadotropin, beta subunit [hCG]) at Visit 1 (Screening) and Visit 2 (Day 1/Baseline), and must practice and be willing to continue to practice appropriate birth control during the entire duration of the study
5. Is able to read, understand, and sign the Informed Consent Form (ICF), communicate
with the investigator, complete study diaries, and understand and comply with protocol
requirements.
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from the study.
1. Use of allopurinol, febuxostat, benzbromarone, probenecid, or sulfinpyrazone within
2 weeks prior to screening.
2. Occurrence of a gouty arthritis flare within 1 week prior to screening or during the
screening period through baseline.
3. Use of colchicine within 1 week prior to screening.
4. Use of any of the following medications within 1 week prior to screening:
a. Glucocorticoids (topical steroids allowed)
b. NSAIDs (topical NSAIDs allowed for purposes other than flare treatment)
c. COX-2 inhibitors
5. History of allergy or hypersensitivity to any component of study medication, including
diacerein.
6. Allergy, contraindication, or intolerance to febuxostat.
7. Any prior use of biologic anti-inflammatory therapy, including IL-1 modulators (anakinra, rilonacept, or canakinumab), tumor necrosis factor inhibitors (etanercept, adalimumab, or golimumab), IL-6 inhibitors (tocilizumab), or T-cell costimulation modulators (abatacept) within 6 months prior to screening.
8. Severe renal impairment (CrCl <30 mL/min; estimated using the Cockcroft-Gault
equation) at screening.
9. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) concentration
>2 times the upper limit of laboratory normal range (>2x ULN) at screening.
10. Has any of the following conditions:
a. Other (non-gout) chronic arthritis (e.g., rheumatoid arthritis, psoriatic arthritis,
ankylosing spondylitis) or other acute inflammatory arthritis (e.g., infectious/septic
arthritis, reactive arthritis, other crystal-induced arthritis); chronic osteoarthritis is
allowed if the nature of the condition is unlikely to confound flare interpretation
b. Autoimmune diseases with arthritis (e.g., systemic lupus erythematosus [SLE],
Behçet's disease, palindromic rheumatism)
c. Any condition requiring chronic daily use of pain medication
11. History of solitary kidney, post-renal transplant, or renal failure requiring regular dialysis treatments.
12. History of clinically significant cardiovascular disease, including significant edema,
congestive heart failure, New York Heart Association Class III or Class IV cardiac status,
unstable angina, myocardial infarction, uncontrolled arrhythmias, cerebrovascular
accident, transient ischemic attack, or any revascularization procedure, within 1 year
prior to screening.
13. Liver cirrhosis or severe hepatic impairment.
14. History of inflammatory bowel disease.
15. Use of azathioprine, mercaptopurine, or theophylline within 1 week of screening.
16. Uncontrolled hypertension, defined as systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg on ≥3 measurements at screening.
17. History of malignant disease (with the exception of basal and squamous cell carcinoma of the skin) within 5 years of screening.
18. Positive test for human immunodeficiency virus (HIV), hepatitis B or C virus (HBV or
HCV), or TB (by chest X-ray).
19. Any clinically significant medical condition or laboratory value that could potentially
affect study participation and/or personal well-being, as judged by the investigator.
20. Has participated in any diacerein studies within 1 year prior to screening.
21. Has participated in a clinical study within 30 days prior to screening.
22. Is an immediate family member (spouse, parent, child, or sibling; biological or legally
adopted) of personnel directly affiliated with the study at the clinical study site, or is
directly affiliated with the study at the clinical study site.
23. Is employed by sponsor (i.e., is an employee, temporary contract worker, or designee
responsible for the conduct of the study).
1. Use of allopurinol, febuxostat, benzbromarone, probenecid, or sulfinpyrazone within
2 weeks prior to screening.
2. Occurrence of a gouty arthritis flare within 1 week prior to screening or during the
screening period through baseline.
3. Use of colchicine within 1 week prior to screening.
4. Use of any of the following medications within 1 week prior to screening:
a. Glucocorticoids (topical steroids allowed)
b. NSAIDs (topical NSAIDs allowed for purposes other than flare treatment)
c. COX-2 inhibitors
5. History of allergy or hypersensitivity to any component of study medication, including
diacerein.
6. Allergy, contraindication, or intolerance to febuxostat.
7. Any prior use of biologic anti-inflammatory therapy, including IL-1 modulators (anakinra, rilonacept, or canakinumab), tumor necrosis factor inhibitors (etanercept, adalimumab, or golimumab), IL-6 inhibitors (tocilizumab), or T-cell costimulation modulators (abatacept) within 6 months prior to screening.
8. Severe renal impairment (CrCl <30 mL/min; estimated using the Cockcroft-Gault
equation) at screening.
9. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) concentration
>2 times the upper limit of laboratory normal range (>2x ULN) at screening.
10. Has any of the following conditions:
a. Other (non-gout) chronic arthritis (e.g., rheumatoid arthritis, psoriatic arthritis,
ankylosing spondylitis) or other acute inflammatory arthritis (e.g., infectious/septic
arthritis, reactive arthritis, other crystal-induced arthritis); chronic osteoarthritis is
allowed if the nature of the condition is unlikely to confound flare interpretation
b. Autoimmune diseases with arthritis (e.g., systemic lupus erythematosus [SLE],
Behçet's disease, palindromic rheumatism)
c. Any condition requiring chronic daily use of pain medication
11. History of solitary kidney, post-renal transplant, or renal failure requiring regular dialysis treatments.
12. History of clinically significant cardiovascular disease, including significant edema,
congestive heart failure, New York Heart Association Class III or Class IV cardiac status,
unstable angina, myocardial infarction, uncontrolled arrhythmias, cerebrovascular
accident, transient ischemic attack, or any revascularization procedure, within 1 year
prior to screening.
13. Liver cirrhosis or severe hepatic impairment.
14. History of inflammatory bowel disease.
15. Use of azathioprine, mercaptopurine, or theophylline within 1 week of screening.
16. Uncontrolled hypertension, defined as systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg on ≥3 measurements at screening.
17. History of malignant disease (with the exception of basal and squamous cell carcinoma of the skin) within 5 years of screening.
18. Positive test for human immunodeficiency virus (HIV), hepatitis B or C virus (HBV or
HCV), or TB (by chest X-ray).
19. Any clinically significant medical condition or laboratory value that could potentially
affect study participation and/or personal well-being, as judged by the investigator.
20. Has participated in any diacerein studies within 1 year prior to screening.
21. Has participated in a clinical study within 30 days prior to screening.
22. Is an immediate family member (spouse, parent, child, or sibling; biological or legally
adopted) of personnel directly affiliated with the study at the clinical study site, or is
directly affiliated with the study at the clinical study site.
23. Is employed by sponsor (i.e., is an employee, temporary contract worker, or designee
responsible for the conduct of the study).
The Estimated Number of Participants
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Taiwan
140 participants
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Global
140 participants
