Ignite Creation Date:
2024-05-06 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03468322
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2018-03-08
Brief Title:
A Double-blind Intra-individual Comparison POC Trial of AC-203 in EB Patients
Sponsor:
TWi Biotechnology Inc
Organization:
TWi Biotechnology Inc
Study Overview
Official Title:
A Double-blind Intra-individual Comparison Proof-of-concept Trial of Topical AC-203 in Patients With Inherited Epidermolysis Bullosa
Status:
COMPLETED
Status Verified Date:
2019-04
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:
Inherited epidermolysis bullosa EB is a genetic skin disorder characterized by skin fragility and recurrent blister formation More and more evidence has suggested that the skin lesions initially caused by genetic mutations may be further aggravated by inflammatory responses Several reports showed successful alleviation of EB symptoms upon treatment with immunomodulatory therapies Modulation of proinflammatory cytokine IL-1β has shown promising results in alleviating epidermolysis bullosa simplex EBS a major subtype of inherited EB by downregulating IL-1β-mediated JNKMAPK signaling pathway This data further supports the potential of using cytokine modulators to treat EB
AC-203 a topical formulation can inhibit the production and activity of IL-1β down-regulate IL-1β receptors and increase IL1β-receptor antagonist IL1-Ra expression In addition AC-203 has been reported to inhibit anti-BP180 autoantibody-induced IL-6IL-8 upregulation in cultured keratinocytes and LPS-induced IL-6 upregulation in cultured macrophages Furthermore AC-203 was also found to inhibit the formation of NLRP3 inflammasome which plays essential roles in induction of caspase-1-dependent pyroptosis and release of inflammatory cytokines IL-1β and IL-18 These studies demonstrated the cytokine modulatory properties of AC-203 and pointed out the possible application of AC-203 in a variety of inflammatory diseases
This study is designed to test the efficacy safety tolerability and pharmacokinetics of AC-203 ointment vs placebo in patients with inherited EB
AC-203 a topical formulation can inhibit the production and activity of IL-1β down-regulate IL-1β receptors and increase IL1β-receptor antagonist IL1-Ra expression In addition AC-203 has been reported to inhibit anti-BP180 autoantibody-induced IL-6IL-8 upregulation in cultured keratinocytes and LPS-induced IL-6 upregulation in cultured macrophages Furthermore AC-203 was also found to inhibit the formation of NLRP3 inflammasome which plays essential roles in induction of caspase-1-dependent pyroptosis and release of inflammatory cytokines IL-1β and IL-18 These studies demonstrated the cytokine modulatory properties of AC-203 and pointed out the possible application of AC-203 in a variety of inflammatory diseases
This study is designed to test the efficacy safety tolerability and pharmacokinetics of AC-203 ointment vs placebo in patients with inherited EB
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?:
False
Is an FDA AA801 Violation?:
None