A Proof-of-Concept Study of AC-201 to Prevent Gout Flares
Condition: Gout Flares
MeSH terms: Gout
Intervention: Placebo; AC-201; Febuxostat
Intervention description: Placebo Capsule BID for 16 Weeks; AC-201 50mg Capsule BID for 16 Weeks; Febuxostat 80 mg QD for 16 Weeks
Intervention MeSH terms: Febuxostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 82.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Prophylaxis of Acute Gout Flares; Urate-Lowering Therapy; Hyperuricemia; Gouty arthritis

Summary:

      Initiation of ULT for gout increases the occurrence of acute gouty arthritis flares due to
      mobilization of urate from tissue deposits. IL-1β plays a key role in mediating the
      inflammatory response in gouty arthritis. The efficacy of IL-1β blockade in the prophylaxis
      of gouty flares during initiation of ULT has been validated in multiple trials of IL-1β
      inhibitor therapies. Therefore, it is believed that IL-1β is a relevant therapeutic target
      for gout flares. AC-201 is an IL-1β modulator indicated for the treatment of osteoarthritis
      with good safety record and very few contraindications to the co-morbidities commonly among
      gout patients. AC-201 has also been demonstrated to have uric acid-lowering effects in
      clinical trials. The favorable product profile of AC-201 overall provides a strong rationale
      for investigating its clinical utility as prophylaxis against flares when initiating ULT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female age 20 to 80 years, inclusive

          -  Meets at least 6 of the 12 American College of Rheumatology preliminary criteria
             (1977) for the classification of acute arthritis of primary gout, OR have proven
             tophus or documented monosodium urate (MSU) crystals in the joint fluid

          -  Serum uric acid ≥7.5 mg/dL at screening

          -  Experienced ≥2 gouty arthritis flares within one year prior to screening

        Exclusion Criteria:

          -  Occurrence of a gouty arthritis flare ongoing at screening or during the screening
             period through baseline

          -  Use of allopurinol, febuxostat, benzbromarone, probenecid, or sulfinpyrazone within 4
             weeks prior to screening

          -  Use of colchicine, glucocorticoids, NSAIDs, or COX-2 inhibitors within 1 week prior to
             screening

          -  Other (non-gout) chronic arthritis, acute inflammatory arthritis, autoimmune diseases
             with arthritis, or any condition requiring chronic daily use of pain medication

          -  History of allergy to any components of study medication, including diacerein

          -  Allergy, contraindication, or intolerance to febuxostat

          -  Contraindication or allergy to NSAIDs

          -  Severe renal impairment

          -  Any prior use of biologic anti-inflammatory therapy, such as IL-1 modulators, tumor
             necrosis factor inhibitors, IL-6 inhibitors, or T-cell costimulation modulator