Ignite Creation Date:
2024-05-06 @ 10:33 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03286582
Status:
TERMINATED
Last Update Posted:
2019-09-19
First Post:
2017-09-14
Brief Title:
A Proof-of-Concept Study of Topical AC-203 in Patients With Bullous Pemphigoid
Sponsor:
TWi Biotechnology Inc
Organization:
TWi Biotechnology Inc
Study Overview
Official Title:
A Randomized Open-Label Controlled Trial of Topical AC-203 in Subjects With Bullous Pemphigoid
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated with partial enrollment completed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Bullous pemphigoid BP is a chronic inflammatory subepidermal autoimmune blistering disease which mainly develops in the elderly with onset usually in the late 70s and a substantial increase in incidence in people older than 80 years If untreated it can persist for months or years with periods of spontaneous remissions and exacerbations It has been found that blisters and sera of BP patients contain abnormally high levels of pro-inflammatory cytokines such as interleukin-6 IL-6 and IL-8 Recently it also has been demonstrated that NLRP3 NACHT LRR and PYD domains-containing protein 3 inflammasome components the NLRP3-caspase-1-IL-18 axis were significantly up-regulated in peripheral blood mononuclear cells from BP patients and positively correlated with disease activity AC-203 is a topical formulation of an oral modulator of inflammasome and IL-1beta pathways In vitro studies have demonstrated that AC-203 significantly reduced secretion of IL-6 and moderately reduced IL-8 secretion in HaCaT cells treated with specific anti-BP180 IgG This study is designed to test the safety tolerability efficacy and pharmacokinetics of AC-203 ointment vs a topical steroid comparator representing standard of care ointment in subjects with BP
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None