NCT03286582

A Proof-of-Concept Study of Topical AC-203 in Patients With Bullous Pemphigoid

A Randomized, Open-Label, Controlled Trial of Topical AC-203 in Subjects With Bullous Pemphigoid

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: TWi Biotechnology, Inc. · Industry
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bullous Pemphigoid

Interventions

Type	Name	Description
DRUG	AC-203 1% Topical Ointment	AC-203 1% ointment BID (twice daily)
DRUG	Clobetasol 0.05% Topical Ointment	Clobetasol 0.05% Topical Ointment BID

Timeline

• Start date: 2017-09-05
• Primary completion: 2018-12-25
• Completion: 2019-01-22
• First posted: 2017-09-18
• Last updated: 2019-09-19

Locations

1 site across 1 country: Taiwan