A Phase 2 interventional study of rVA576 in Bullous Pemphigoid (BP), sponsored by AKARI Therapeutics. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-22.
Sponsored by AKARI Therapeutics · Phase 2, Interventional, and Treatment
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
Cutaneous bullous pemphigoid (BP) per standard diagnostic criteria:
Exclusion Criteria:
Drug: rVA576
BP subjects will be treated with 30 mg once daily rVA576 regime for 6 weeks.
Safety parameter
Proportion of participants reporting grade 3, 4 and 5 adverse events, which are related/possibly related to rVA576 during the treatment period. Treatment emergent adverse events (TEAEs) consist of: * Change from baseline in physical examination * ECG * Clinical laboratory tests * Vital signs The Common Terminology Criteria for Adverse Events (CTCAE v4.03) will be used to grade adverse events.
Time frame: 42 days
Efficacy Parameter
Change in BPDAI between baseline (Day 1) and Day 42.
Time frame: 42 days
Quality of life questionnaire
Change in quality of life questionnaire between baseline (Day 1) and Day 42
Time frame: 42 days
Plan to share: Undecided
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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AKARI Therapeutics