A Proof-of-Concept Study of AC-201 to Prevent Gout Flares
Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
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.