Clinical Trials List
2012-11-01 - 2014-11-01
Phase II
Terminated7
Study ended1
A Randomized, Double-Blind, Placebo-Controlled Trial of AC-201 In Subjects with Gout Initiating Urate-Lowering Therapy
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Trial Applicant
TWI BIOTECHNOLOGY, INC
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chang-Youh Tsai Division of Rheumatology
- Wei-Sheng Chen Division of Rheumatology
- 劉德鈴 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
- 歐燦騰 風濕免疫科
- 吳正欽 風濕免疫科
- Wen Chan Tsai 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 林靖麒 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Po-Hao Huang 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Study ended
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
To evaluate the efficacy of AC-201 to reduce the occurrence of gouty flares in subjects with gout initiating urate-lowering therapy.
SECONDARY OBJECTIVES
To evaluate the safety and tolerability of AC-201 in subjects with gout initiating
urate-lowering therapy.
To assess the change in serum uric acid in subjects with gout initiating urate-lowering therapy with or without AC-201.
Inclution Criteria
1. Male or female age 20 to 80 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 at screening
4. Experienced ≥2 gouty arthritis flares within one year prior to screening
5. 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
6. 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
1. Occurrence of a gouty arthritis flare ongoing at screening or during the screening period through baseline.
2. Use of allopurinol, febuxostat, benzbromarone, probenecid, or sulfinpyrazone within
4 weeks prior to screening.
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
b. NSAIDs
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. Contraindication to or history of allergy or hypersensitivity to diclofenac or any other
NSAIDs (including aspirin).
8. 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).
9. Severe renal impairment (CrCl <30 mL/min; estimated using the Cockcroft-Gault
equation) at screening.
10. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) concentration >3x upper limit of laboratory normal range (ULN) at screening.
11. 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)
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
12. History of solitary kidney, post-renal transplant, or renal failure requiring regular dialysis treatments.
13. 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.
14. Liver cirrhosis or severe hepatic impairment.
15. Active peptic ulcer requiring treatment with proton pump inhibitors or H2 receptor
antagonists.
16. History of inflammatory bowel disease.
17. Asthma that may require the use of theophylline or glucocorticoids.
18. Use of azathioprine, mercaptopurine, or theophylline within 1 week of screening.
19. Uncontrolled hypertension, defined as systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg on ≥3 measurements at screening.
20. History of malignant disease (with the exception of basal and squamous cell carcinoma of the skin) within 5 years of screening.
21. Active tuberculosis receiving anti-tuberculosis medication (e.g., pyrazinamide,
ethambutol).
22. Any clinically significant medical condition or laboratory value that could potentially
affect study participation and/or personal well-being, as judged by the investigator.
23. Has participated in any diacerein studies within 1 year prior to screening.
24. Has participated in an investigational drug study within 30 days prior to screening.
25. 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.
26. 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
60 participants
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Global
80 participants
