Ignite Creation Date:
2024-05-06 @ 1:01 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01712204
Status:
COMPLETED
Last Update Posted:
2018-05-22
First Post:
2012-10-19
Brief Title:
A Proof-of-Concept Study of AC-201 to Prevent Gout Flares
Sponsor:
TWi Biotechnology Inc
Organization:
TWi Biotechnology Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Trial Of AC-201 In Subjects With Gout Initiating Urate-Lowering Therapy
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Clinical trials have demonstrated that anti-IL-1 agents IL-1Ra IL-1 Trap and anti-IL-1β monoclonal antibody can reduce the frequency of gout flares during the initial period of treatment with urate-lowering therapy and prevent of gout flares in gout patients with frequent flares AC-201 is an oral IL-1 modulator but with a mechanism distinct from that of existing anti-IL-1 agents The active metabolite of AC-201 has been shown in vitro and in vivo to inhibit the production and activity of IL-1 down-regulate IL-1 receptors and increase IL1-Ra Molecular research further suggests that these effects are mediated upstream via inhibition of MAPK signaling pathways and binding of NF-κB and AP-1 transcription factors that encode for a range of pro-inflammatory factors including IL-1β TNF-α IL-6 IL-8 iNOS and MMPs which have been implicated in gout flares 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None