NCT04035733

rVA576 in Adult Mild to Moderate Bullous Pemphigoid Subjects

A Phase IIa Open-label Single Arm Study of Safety and Efficacy of rVA576 in Adult Mild to Moderate Bullous Pemphigoid Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: AKARI Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Bullous pemphigoid (BP) is the most common of the autoimmune blistering skin diseases in Western Europe. \[Joly 2012\]The study will recruit the new onset or relapsing mild to moderate BP patients. The study population will consist of patients above the age of 18 years with an active episode of BP, confirmed by inclusion and exclusion criteria and who, in the opinion of the Investigator, would benefit from treatment with rVA576. Recombinant rVA576 is a small protein complement C5 and LTB4 inhibitor, which prevents the cleavage of C5 by C5 convertase and thereby inhibits generation of C5b-9 the membrane attack complex (MAC), as well as preventing the release of the anaphylatoxin C5a. rVA576 is effective in inhibiting terminal complement activity irrespective of the activating pathway (classical, lectin or alternative). This Phase IIa open-label single-arm study will evaluate the safety and efficacy of rVA576 in adult mild to moderate Bullous Pemphigoid patients

Conditions

• Bullous Pemphigoid (BP)

Interventions

Type	Name	Description
DRUG	rVA576	BP subjects will be treated with 30 mg once daily rVA576 regime for 6 weeks.

Timeline

• Start date: 2018-09-25
• Primary completion: 2020-03-12
• Completion: 2020-04-29
• First posted: 2019-07-29
• Last updated: 2025-04-22

Locations

2 sites across 2 countries: Germany, Netherlands