Phase 2
N=82
A Proof-of-Concept Study of AC-201 to Prevent Gout Flares
Gout Flares
Bottom Line
View on ClinicalTrials.gov: NCT01712204 ↗Enrolled (actual)
82
Serious AEs
1.2%
Results posted
Dec 2014
Primary outcome: Primary: Number of Gout Flares Per Subject — 3.02; 2.45 flares — p=0.1356
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); AC-201 (Drug); Febuxostat (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- TWi Biotechnology, Inc.
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Gout Flares Per Subject |
3.02; 2.45 | 0.1356 |
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
Data sourced from ClinicalTrials.gov (NCT01712204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.