A Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Gout

NCT ID: NCT02287818

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-10-27

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.

Conditions

Gout

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Placebo plus Febuxostat

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo twice daily from Day 1 to Week 12

Febuxostat

Intervention Type: DRUG

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

AC-201

AC-201 CR tablet plus Febuxostat

Group Type: EXPERIMENTAL

AC-201

Intervention Type: DRUG

AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12

Febuxostat

Intervention Type: DRUG

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

Interventions

Placebo

Placebo twice daily from Day 1 to Week 12

Intervention Type: DRUG

AC-201

AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12

Intervention Type: DRUG

Febuxostat

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

Intervention Type: DRUG

Other Intervention Names

PBO; AC-201 CR tablet; ULT

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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 Glucocorticoids, NSAIDs or COX-2 inhibitors within 1 week prior to screening.

5. Allergy, contraindication, or intolerance to febuxostat.

6. Severe renal impairment.

7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) concentration >2 times the upper limit of laboratory normal range (>2x ULN) at screening.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TWi Biotechnology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chang-Youh Tsai

Role: PRINCIPAL_INVESTIGATOR

Taipei Veteran General Hospital (TVGH)

Locations

Taipei Veteran General Hospital (TVGH)

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

AC-201-GOU-002

Identifier Type: -

Identifier Source: org_study_id