Back to resultsA Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Gout
Primary Purpose
Gout
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo
AC-201
Febuxostat
Sponsored by
About this trial
This is an interventional treatment trial for Gout
Eligibility Criteria
Inclusion Criteria:
- Male or female age 20 to 65 years, inclusive.
- 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.
- 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.
Exclusion Criteria:
- Use of allopurinol, febuxostat, benzbromarone, probenecid, or sulfinpyrazone within 2 weeks prior to screening.
- Occurrence of a gouty arthritis flare within 1 week prior to screening or during the screening period through baseline.
- Use of colchicine within 1 week prior to screening.
- Use of Glucocorticoids, NSAIDs or COX-2 inhibitors within 1 week prior to screening.
- Allergy, contraindication, or intolerance to febuxostat.
- Severe renal impairment.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) concentration >2 times the upper limit of laboratory normal range (>2x ULN) at screening.
Sites / Locations
- Taipei Veteran General Hospital (TVGH)
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
AC-201
Arm Description
Placebo plus Febuxostat
AC-201 CR tablet plus Febuxostat
Outcomes
Primary Outcome Measures
Proportion of Subjects Achieving Serum Uric Acid Concentration <6.0 mg/dL
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02287818
Brief Title
A Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Gout
Official Title
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF AC-201 IN SUBJECTS WITH GOUT
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
October 27, 2016 (Actual)
Study Completion Date
October 27, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TWi Biotechnology, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is designed to test the urate-lowering effect, safety, and tolerability of AC-201CR in an initial dosing period, followed by the addition of a ULT to test the efficacy and safety of the combination and prophylaxis of gout flares during ULT.
Detailed Description
AC-201CR is a control released formulation of AC-201 that in previous clinical studies showed potential dual effects in both reducing serum uric acid (sUA) and gout flares. The mechanism of action of AC-201 includes the inhibition of the production and activity of caspase-1 and interleukin-1β (IL-1β), and selective inhibition of re-absorption transporters in the kidney. The goal of gout treatment is to reduce serum uric acid (sUA) concentrations below the urate solubility limit while avoiding acute gout flares. However, the initiation of urate-lowering therapy (ULT) increases the occurrence of acute gouty arthritis flares. IL-1β plays a key role in mediating this inflammatory response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo plus Febuxostat
Arm Title
AC-201
Arm Type
Experimental
Arm Description
AC-201 CR tablet plus Febuxostat
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
PBO
Intervention Description
Placebo twice daily from Day 1 to Week 12
Intervention Type
Drug
Intervention Name(s)
AC-201
Other Intervention Name(s)
AC-201 CR tablet
Intervention Description
AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12
Intervention Type
Drug
Intervention Name(s)
Febuxostat
Other Intervention Name(s)
ULT
Intervention Description
Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration <6 mg/dL
Primary Outcome Measure Information:
Title
Proportion of Subjects Achieving Serum Uric Acid Concentration <6.0 mg/dL
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female age 20 to 65 years, inclusive.
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.
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.
Exclusion Criteria:
Use of allopurinol, febuxostat, benzbromarone, probenecid, or sulfinpyrazone within 2 weeks prior to screening.
Occurrence of a gouty arthritis flare within 1 week prior to screening or during the screening period through baseline.
Use of colchicine within 1 week prior to screening.
Use of Glucocorticoids, NSAIDs or COX-2 inhibitors within 1 week prior to screening.
Allergy, contraindication, or intolerance to febuxostat.
Severe renal impairment.
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) concentration >2 times the upper limit of laboratory normal range (>2x ULN) at screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang-Youh Tsai
Organizational Affiliation
Taipei Veteran General Hospital (TVGH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veteran General Hospital (TVGH)
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Gout
We'll reach out to this number within 24 hrs